Evaluating the Effectiveness of an Online Small-Group Self-Management Workshop for Rural Caregivers of Individuals With Alzheimer's Disease and Related Dementias
Phase: NA
Conditions: Depression, Stress, Psychological, Self Efficacy, Loneliness, Social Isolation, Health Care Utilization, Dementia, Dementia Alzheimers, Dementia of Alzheimer Type, Dementia, Vascular, Dementia Frontal, Dementia, Lewy Body, Dementia, Mixed, Dementia in Parkinsons Disease, Dementia, HIV, Dementia Frontotemporal, Dementia, Multi-Infarct
Sponsor: University of California, San Francisco

Study Application (Version 1.1)
1.0
General Information
*Enter the full title of your study:
Evaluating the Effectiveness of an Online Small-Group Self-Management Workshop for Rural 
Caregivers of Individuals with Alzheimer’s Disease and Related Dementias
*Enter the study alias:
Workshop for rural ADRD caregivers
* This field allows you to enter an abbreviated version of the Study Title to quickly identify this
study.
2.0
Add departments
2.1 and Specify Research Location:
Is 
Primary? Department Name
UCSF - 
 - M_MED-CORE-DGIM
138335
3.0
List the key study personnel: (Note: external and affiliated collaborators who 
are not in the UCSF directory can be identified later in the Qualifications of 
Key Study Personnel section at the end of the form)
3.1 *Please add a Principal Investigator for the study:
Yank, Veronica, MD
Select if applicable
Department Chair
Resident
Fellow
If the Principal Investigator is a Fellow, the name of the Faculty Advisor must be supplied below.
3.2 If applicable, please select the Research Staff personnel
A) Additional Investigators
Cheng, Jing, PhD 
Other Investigator
Chesla, Catherine, RN, PhD, FAAN 
Other Investigator
Covinsky, Kenneth E 
Other Investigator
Karliner, Leah, MD 
Other Investigator
N
NCT04428112
August 15, 2018

B) Research Support Staff
Barajas, Raquel 
 Research Assistant
Santoyo-Olsson, Jasmine 
 Study Coordinator
3.3 *Please add a Study Contact
 
Agarwal, Sanjhavi 
Barajas, Raquel 
Santoyo-Olsson, Jasmine 
Santoyo-Olsson, Jasmine 
Yank, Veronica, MD 
The Study Contact(s) will receive all important system notifications along with the Principal 
Investigator. (e.g. The project contact(s) are typically either the Study Coordinator or the Principal 
Investigator themselves).
3.4 If applicable, please add a Faculty Advisor/Mentor:
 
3.5 If applicable, please select the Designated Department Approval(s)
 
Add the name of the individual authorized to approve and sign off on this protocol from your 
Department (e.g. the Department Chair or Dean).
4.0
 
Initial Screening Questions
Updated June 2017
4.1  
: 
* PROJECT SUMMARY
 
(REQUIRED) Give a brief overview of this project (250 words or less). Tell us 
what this study is about, who is being studied, and what it aims to achieve. If you have an NIH 
  
Abstract, paste it here:  Click on the orange question mark to the right for more detailed instructions.
Among 13 million informal caregivers of individuals with Alzheimer’s disease or related 
dementias, an estimated 1.4 million live in rural areas of the US. These caregivers are a 
vulnerable group due to their physical isolation and well-documented rural disparities in health 
care access and quality. Many rural dementia caregivers experience serious health consequences 
due to caregiving responsibilities that can limit their ability to maintain their caregiving role. Thus, 
there is an pressing need for effective, scalable, and accessible programs to support rural 
dementia caregivers so that they can sustain their own well-being and effective caregiving within 
the home environments of their loved ones.
Online programs offer a convenient and readily translatable option for program delivery because 
they can be accessed by caregivers in the home environment and at the convenience of the user. 
 is an online 6-week, interactive, small-group self-management, social 
Building Better Caregivers
support, and skills-building workshop developed for caregivers of individuals with Alzheimer’s 
disease or related forms of dementia. In our evaluations of the program in non-randomized 
studies, caregivers experienced significant improvements in stress, depression symptoms, and 
self-efficacy and partners experienced improved well-being.
Building on these encouraging preliminary findings, we now propose to conduct a hybrid 
effectiveness-implementation randomized controlled trial that will enroll and randomize 640 rural 
dementia caregivers into two groups: 320 in the intervention (workshop) group and 320 in the 

attention control group. Caregivers will be recruited through 19 community organizations (serving 
rural communities in 17 states). Primary outcomes will be caregiver stress and depression 
symptoms. We hypothesize that stress scores and depression symptoms will be significantly 
improved at 12 months in the intervention group versus control group. We will also identify key 
strengths (facilitators) and weaknesses (barriers) of workshop implementation. We will use the 
RE-AIM implementation framework and a mixed methods approach to identify implementation 
characteristics pertinent to both caregivers and rural community organizations.
If the 
 workshop is proven to be effective, this research has the 
Building Better Caregivers
potential to open new research horizons, particularly on how to reach and effectively support 
isolated dementia caregivers in rural areas with an intervention that is scalable, even in low-
resourced settings. If the workshop can achieve its goals with rural dementia caregivers, some of 
those most isolated, it would also be expected to be scalable in other low-resourced settings (e.
g., in urban or suburban environments).
 
4.2  
: 
* HUD DEVICE (REQUIRED) Does this application involve a 
 (HUD):
Humanitarian Use Device
No 
Yes, and it includes a research component 
Yes, and it involves clinical care ONLY 
4.3  
: (Click the Help link for definitions and guidance): 
* TYPE OF RESEARCH
 
(REQUIRED)
Biomedical research 
Social, behavioral, educational, and/or public policy research 
Hybrid - includes aspects of BOTH types of research (check this option if your research is 
mainly social/behavioral but also involves specimen collection or blood draws to look at 
biological measures) 
4.4  
 
* SUBJECT CONTACT:
 
(REQUIRED) Does this study involve 
 contact or interactions with 
ANY
participants:
Yes (including phone, email or web contact) 
No (limited to medical records review, biological specimen analysis, and/or data analysis) 
4.5  
Does your protocol involve any radiation exposure to patients/subjects 
* RADIATION EXPOSURE: 
 from 
 
for 
 purposes (e.g., x-rays, CT-scans, DEXA, CT-guided biopsy, 
EITHER
standard care
 
OR
research
radiation therapy, or nuclear medicine including PET, MUGA or bone scans): (REQUIRED)
  Yes  
  No
4.6  
 
* RISK LEVEL: 
 
(REQUIRED) What is your estimation of the risk level, including all screening 
procedures and study activities 
:
(Help Text updated 9/13)
Minimal risk 
Greater than minimal risk 
4.7  * REVIEW LEVEL: 
 
(REQUIRED) Requested review level (Click on the orange question mark to the 
right for definitions and guidance):
Full Committee 
Expedited 
Exempt 

4.8  
 
* EXPEDITED REVIEW CATEGORIES:
 
(REQUIRED)     If you think this study qualifies for expedited 
 
review, select the 
 that the research falls under: (check all that apply)
regulatory categories
Category 1: A very limited number of studies of approved drugs and devices
Category 2: Blood sampling
Category 3: Noninvasive specimen collection (e.g. buccal swabs, urine, hair and nail clippings, 
etc.)
Category 4: Noninvasive clinical procedures (e.g. physical sensors such as pulse oximeters, 
MRI, EKG, EEG, ultrasound, moderate exercise testing, etc.)
Category 5: Research involving materials (data, documents, records, or specimens) that were 
previously collected for either nonresearch or research purposes
Category 6: Use of recordings (voice, video, digital or image)
Category 7: Low risk behavioral research or research employing survey, interview, oral 
history, focus group, program evaluation, human factors evaluation, or quality assurance 
methodologies
4.11  
 
* CLINICAL TRIAL:
 
(REQUIRED)     Is this a clinical trial? According to The World Health Organization 
    
(WHO) and the International Committee of Medical Journal Editors (ICMJE) a 
is:
 
clinical trial
 
Any research study that prospectively assigns human participants or groups of humans to one 
or more health-related interventions to evaluate the effects on health outcomes.
      ICMJE requires 
 of a clinical trial in a public database (such as ClinicalTrials.gov) 
registration
    
prior to enrollment, for eventual publication of results in member biomedical journals.
Guidance: 
Public Law 110-85 requires that all investigators who perform an 
 must 
applicable clinical trial
        
ensure that the trial is registered on a government web site called 
.
ClinicalTrials.gov
 
The FDA 
   
requires registration for “applicable clinical trials,” defined as follows:
For any trials of drugs and biologics: controlled clinical investigations, other than Phase 1 
investigations, of a product subject to FDA regulation.
For trials of biomedical devices: controlled trials with health outcomes of devices subject to 
FDA regulation, other than small feasibility studies, and pediatric post-market surveillance.
    For additional information on the 
 registration process at UCSF and the definition 
ClinicalTrials.gov
of a clinical trial for purposes of registration, visit the ClinicalTrials.gov section of the UCSF Clinical 
 
  
  
Research Resource HUB.
 Yes  
 No
Clinical Trial Registration
  "NCT" number for this trial:
pending
If you don't yet have the NCT#, type 'Pending.' 
4.12  
 
* CLINICAL TRIAL PHASE (REQUIRED) Check the applicable phase(s) 
:
(Help Text updated 9/13)
Phase I
Phase II
Phase III
Phase IV
4.13  
: 
* INVESTIGATOR-INITIATED
 
(REQUIRED) Is this an investigator-initiated study:
 Yes  
 No
4.14    
    
 
* CANCER: (REQUIRED)
Does this study involve cancer (e.g., the study involves patients with 
cancer or at risk for cancer, including behavioral research, epidemiological research, public policy 

  
research, specimen analysis, and chart reviews):  
  Yes  
  No
If you don't know if you should answer 'Yes' or 'No,' please 
 the 
email
Cancer Center's Protocol Review Committee for help.
4.15  SCIENTIFIC REVIEW: If this study has undergone scientific or scholarly review, please indicate 
which entity performed the review (check all that apply):
Cancer Center Protocol Review Committee (PRC) (Full approval is required prior to final CHR 
approval for cancer-related protocols.)
CTSI Clinical Research Services (CRS) Advisory Committee
CTSI Consultation Services
Departmental scientific review
Other:
 Specify 
*
Other: (REQUIRED)
National Institute of Health of Health Center for Scientific Review Special Emphasis Panel: Health 
Disparities in Caregiving for Alzheimer's Disease
4.17    
    
 
* FINANCIAL INTERESTS: (REQUIRED)
Do you or any other responsible personnel (or the spouse, 
registered domestic partner and/or dependent children thereof) have 
 related to 
financial interests
  
this study:  
  Yes  
  No
5.0
 Funding
5.1  
FEDERAL FUNDING: 
* 
(REQUIRED) Is this study currently supported in whole or in part by Federal 
funding, 
, OR has it received 
 Federal funding in the past:
even by a subcontract
ANY
 Yes  
 No
The IRB is required to compare the grant to the IRB application for studies 
with federal support. Indicate which portion of your grant you will be 
attaching:
For NIH grants, the Research Plan, including the Human Subjects Section
For other federal proposals (contracts or grants), the section of the proposal describing 
human subjects work
The section of your progress report if it provides the most current information about your 
human subjects work
The grant is not attached. The study is funded by an award that does not describe specific 
plans for human subjects, such as career development awards (K awards), cooperative 
agreements, program projects, and training grants (T32 awards) OR UCSF (or the affiliate 
institution) is not the prime recipient of the award
5.2  
Is this project linked in any way to the Department of Defense (DoD): 
* DoD INVOLVEMENT: 
(REQUIRED)
  Yes  
  No
5.3  
 
SPONSORS: Identify all sponsors and provide the funding details. If funding comes from a 
 
Subcontract, please list only the Prime Sponsor:

External Sponsors:
 
 
View 
Details
Sponsor Name
Sponsor Type
Awardee 
Institution:
Contract 
Type:
Project 
Number 
UCSF 
RAS 
System 
Award 
Number 
("A" + 
6 
digits) 
No Sponsor has been added to this IRB Study
If the funding is coming through UCSF and you don't know 
the A or P number,  you can search the eProposal side for 
the contract or grant (this does NOT replace adding the 
sponsor by name above 
 entering the A or P number):
AND
Project Status
Proposal Number
Project Title
Principal 
Investigator
No Projects are Linked to this IRB Study
Other Funding Sources and Unfunded Research - 
Gift, Program, or Internal Funding (check all that 
apply):
Funded by gift (specify source below)
Funded by UCSF or UC-wide program (specify source below)
Specific departmental funding (specify source below)
Unfunded (miscellaneous departmental funding)
Unfunded student project
6.0
 Sites, Programs, Resources, and External IRB Review
6.1  
 
 (check all that apply):
UCSF AND AFFILIATED SITES
UCSF (including Laurel Heights and all the other sites outside the main hospitals)
Parnassus
Mission Bay
China Basin
Mount Zion
Helen Diller Family Comprehensive Cancer Center
Langley Porter Psychiatric Institute
San Francisco General Hospital (SFGH)
SF VA Medical Center (SF VAMC)
Blood Centers of the Pacific (BCP)
Blood Systems Research Institute (BSRI)
Fresno Community Medical Center
Gallo
Gladstone
Jewish Home

Institute on Aging (IOA)
SF Dept of Public Health (DPH)
6.2  
At what locations will study visits and activities occur:
LOCATIONS: 
Community organizations will be engaged in all phases of the project via a longitudinal webinar- 
and list-serve-based Learning Collaborative. The confirmed sites include: California Center for 
Rural Policy, Humboldt Independent Practice Association, Elder Options, Eastern Idaho 
Community Action Partnership, Bluegrass Area Agency on Aging and Independent Living, Maine 
Health, MAC Incorporated (Maintaining Active Citizens), Elder Services of the Merrimack Valley, 
Inc., University of Nebraska Medical Center (UNMC) College of Nursing, Centralina Area Agency 
on Aging, North Carolina Department of Health and Human Services, Division of Aging and Adult 
Services, South Dakota State University, North Central Texas Council of Governments, Area 
Agency on Aging of North Texas, Area Agency on Aging of the Panhandle, Area Agency on Aging 
of Tarrant County, Texas A&M Center for Population Health and Aging, Wisconsin Institute for 
Healthy Aging, and Wyoming Center on Aging, University of Wyoming.
Study participants will be recruited through 19 community organizations (serving rural 
communities in 17 states). They will provide input on recruitment approaches and will provide 
organization preferences and suggestion for recruitment of the rural caregivers they serve.  All 
centers have agreed to help with recruitment efforts by distributing flyers, posting 
flyers, mailings, brochures, radio ads, list-serve, etc.
Intervention group participants: will access the Building Better Caregivers 6-week program online 
at home. The workshop platform has the capability to track user engagement data such as 
number of workshop log-ins, website sections visited, number of postings/messages, action plans 
made and completed, and workshop completion.
Control group participants: will receive a mailed educational packet and two brief staff phone calls.
Survey data will be collected through online surveys completed by caregivers and conducted at 
baseline, post-intervention (1.5 months), and 6, and 12 months using the secure REDCap 
application. We will also give participants the option to complete questions by mail or phone 
interview.
6.3  
Will any study procedures or tests be conducted off-site by non-UCSF 
OFF-SITE PROCEDURES: 
personnel:
  Yes  
  No
6.4  RESEARCH PROGRAMS: Check any UCSF research programs this study is associated with:
Cancer Center
Center for AIDS Prevention Sciences (CAPS)
Global Health Sciences
Immune Tolerance Network (ITN)
Neurosciences Clinical Research Unit (NCRU)
Osher Center
Positive Health Program
6.5  * CTSI CRS SERVICES: (REQUIRED) Will this study be carried out at one of the UCSF Clinical Research 
 units or utilize 
:
Services (CRS)
CRS services
  Yes  
  No
6.6  * MULTI-CENTER TRIAL:
 
 (REQUIRED) Is this a multicenter research trial? By multi-center trial, we 
mean a study where the protocol is developed by an industry sponsor, consortium, a disease-group, 
etc., who then selects sites across the nation or in different countries to participate in the trial. The 
local sites do not have any control over the design of the protocol. 

  Yes  
  No
6.7  
Check all the other types of sites not affiliated with UCSF with which you are 
OTHER SITE TYPES: 
cooperating or collaborating on this project:   Do NOT check any boxes below if this is a 
multi-center clinical trial, UCSF is just one of the sites, and neither UCSF nor its 
affiliates are the coordinating center.
Other UC Campus
Other institution
Other community-based site
Foreign Country
Sovereign Native American nation (e.g. Navajo Nation, Oglala Sioux Tribe, Havasupai, etc.)
6.10  
Does this application include a request to rely on an external IRB 
* 
: 
RELYING ON AN EXTERNAL IRB
other than the NCI IRB (e.g. UC reliance, private/commercial IRB, or institutional IRB): 
 
(REQUIRED)
        
 
Check out the orange question mark to the right to find out if your study is 
 
eligible for external IRB review.
  Yes  
  No
7.0
 Outside Site Information
7.1  
 
Outside Site Information
Click "Add a new row" to enter information for a site. Click it again to add a second site again to 
add a third site, a fourth site, etc.
Outside Site Information
Non-UCSF affiliated site information:
Site name:
California Center for Rural Policy
Contact name:
Connie Stewart
Email:
Phone:
707-826-3400
For Federally-funded studies only, corresponding FWA#:

 research at this site will be reviewed by:
* The
The non-affiliated site's IRB or a private IRB 
The non-affiliated site is requesting UCSF to be the IRB of 
record for this study 
The non-affiliated site is not engaged in the human subjects 
research and has provided a letter of support 
If the other site's IRB approval letter is available now, attach it to 
the application.  If the IRB approval letter is not yet available, 
submit it once you receive it. 
  
  Or, if the other site is 
 in human subjects 
 
not engaged
research, attach the letter of support to your application.
Outside Site Information
Non-UCSF affiliated site information:
Site name:
Humboldt Independent Practice Association
Contact name:
Rosemary DenOuden
Email:
Phone:
707-443-4563
For Federally-funded studies only, corresponding FWA#:
 research at this site will be reviewed by:
* The
The non-affiliated site's IRB or a private IRB 
The non-affiliated site is requesting UCSF to be the IRB of 
record for this study 
The non-affiliated site is not engaged in the human subjects 
research and has provided a letter of support 
If the other site's IRB approval letter is available now, attach it to 
the application.  If the IRB approval letter is not yet available, 
submit it once you receive it. 
  
  Or, if the other site is 
 in human subjects 
 
not engaged
research, attach the letter of support to your application.

Outside Site Information
Non-UCSF affiliated site information:
Site name:
Elder Options
Contact name:
Kristen Griffis
Email:
Phone:
352-378-6649
For Federally-funded studies only, corresponding FWA#:
 research at this site will be reviewed by:
* The
The non-affiliated site's IRB or a private IRB 
The non-affiliated site is requesting UCSF to be the IRB of 
record for this study 
The non-affiliated site is not engaged in the human subjects 
research and has provided a letter of support 
If the other site's IRB approval letter is available now, attach it to 
the application.  If the IRB approval letter is not yet available, 
submit it once you receive it. 
  
  Or, if the other site is 
 in human subjects 
 
not engaged
research, attach the letter of support to your application.
Outside Site Information
Non-UCSF affiliated site information:
Site name:
Eastern Idaho Community Action Partnership
Contact name:
Morgan Nield
Email:

Phone:
208-522-5391
For Federally-funded studies only, corresponding FWA#:
 research at this site will be reviewed by:
* The
The non-affiliated site's IRB or a private IRB 
The non-affiliated site is requesting UCSF to be the IRB of 
record for this study 
The non-affiliated site is not engaged in the human subjects 
research and has provided a letter of support 
If the other site's IRB approval letter is available now, attach it to 
the application.  If the IRB approval letter is not yet available, 
submit it once you receive it. 
  
  Or, if the other site is 
 in human subjects 
 
not engaged
research, attach the letter of support to your application.
Outside Site Information
Non-UCSF affiliated site information:
Site name:
Bluegrass Area Agency on Aging and Independent Living
Contact name:
Lydia M. Jacobs
Email:
Phone:
859-269-8021
For Federally-funded studies only, corresponding FWA#:
 research at this site will be reviewed by:
* The
The non-affiliated site's IRB or a private IRB 
The non-affiliated site is requesting UCSF to be the IRB of 
record for this study 
The non-affiliated site is not engaged in the human subjects 
research and has provided a letter of support 
If the other site's IRB approval letter is available now, attach it to 
the application.  If the IRB approval letter is not yet available, 
submit it once you receive it. 

  
  Or, if the other site is 
 in human subjects 
 
not engaged
research, attach the letter of support to your application.
Outside Site Information
Non-UCSF affiliated site information:
Site name:
Maine Health
Contact name:
Margaret S. Haynes
Email:
Phone:
207-661-7001
For Federally-funded studies only, corresponding FWA#:
 research at this site will be reviewed by:
* The
The non-affiliated site's IRB or a private IRB 
The non-affiliated site is requesting UCSF to be the IRB of 
record for this study 
The non-affiliated site is not engaged in the human subjects 
research and has provided a letter of support 
If the other site's IRB approval letter is available now, attach it to 
the application.  If the IRB approval letter is not yet available, 
submit it once you receive it. 
  
  Or, if the other site is 
 in human subjects 
 
not engaged
research, attach the letter of support to your application.
Outside Site Information
Non-UCSF affiliated site information:
Site name:
MAC Incorporated (Maintaining Active Citizens)
Contact name:

Leigh Ann Eagle
Email:
Phone:
410-742-0505 x 136
For Federally-funded studies only, corresponding FWA#:
 research at this site will be reviewed by:
* The
The non-affiliated site's IRB or a private IRB 
The non-affiliated site is requesting UCSF to be the IRB of 
record for this study 
The non-affiliated site is not engaged in the human subjects 
research and has provided a letter of support 
If the other site's IRB approval letter is available now, attach it to 
the application.  If the IRB approval letter is not yet available, 
submit it once you receive it. 
  
  Or, if the other site is 
 in human subjects 
 
not engaged
research, attach the letter of support to your application.
Outside Site Information
Non-UCSF affiliated site information:
Site name:
Elder Services of the Merrimack Valley, Inc.
Contact name:
Rosanne DiStefano
Email:
Phone:
978-687-7747
For Federally-funded studies only, corresponding FWA#:
 research at this site will be reviewed by:
* The
The non-affiliated site's IRB or a private IRB 
The non-affiliated site is requesting UCSF to be the IRB of 
record for this study 

The non-affiliated site is not engaged in the human subjects 
research and has provided a letter of support 
If the other site's IRB approval letter is available now, attach it to 
the application.  If the IRB approval letter is not yet available, 
submit it once you receive it. 
  
  Or, if the other site is 
 in human subjects 
 
not engaged
research, attach the letter of support to your application.
Outside Site Information
Non-UCSF affiliated site information:
Site name:
University of Nebraska Medical Center (UNMC) College of Nursing
Contact name:
Sue Barnason PhD, RN, APRN-CNS, CEN, CCRN, FAHA, FAEN, 
FAAN
Email:
Phone:
402-472-7359
For Federally-funded studies only, corresponding FWA#:
 research at this site will be reviewed by:
* The
The non-affiliated site's IRB or a private IRB 
The non-affiliated site is requesting UCSF to be the IRB of 
record for this study 
The non-affiliated site is not engaged in the human subjects 
research and has provided a letter of support 
If the other site's IRB approval letter is available now, attach it to 
the application.  If the IRB approval letter is not yet available, 
submit it once you receive it. 
  
  Or, if the other site is 
 in human subjects 
 
not engaged
research, attach the letter of support to your application.
Outside Site Information
Non-UCSF affiliated site information:

Site name:
Centralina Area Agency on Aging
Contact name:
Linda H. Miller
Email:
Phone:
704-372-2416
For Federally-funded studies only, corresponding FWA#:
 research at this site will be reviewed by:
* The
The non-affiliated site's IRB or a private IRB 
The non-affiliated site is requesting UCSF to be the IRB of 
record for this study 
The non-affiliated site is not engaged in the human subjects 
research and has provided a letter of support 
If the other site's IRB approval letter is available now, attach it to 
the application.  If the IRB approval letter is not yet available, 
submit it once you receive it. 
  
  Or, if the other site is 
 in human subjects 
 
not engaged
research, attach the letter of support to your application.
Outside Site Information
Non-UCSF affiliated site information:
Site name:
North Carolina Department of Health & Human Services Division 
of Aging & Adult
Contact name:
Alicia Blater, M.S
Email:
alicia.blater@dhhs.nc.gov
Phone:
919-855-3400

For Federally-funded studies only, corresponding FWA#:
 research at this site will be reviewed by:
* The
The non-affiliated site's IRB or a private IRB 
The non-affiliated site is requesting UCSF to be the IRB of 
record for this study 
The non-affiliated site is not engaged in the human subjects 
research and has provided a letter of support 
If the other site's IRB approval letter is available now, attach it to 
the application.  If the IRB approval letter is not yet available, 
submit it once you receive it. 
  
  Or, if the other site is 
 in human subjects 
 
not engaged
research, attach the letter of support to your application.
Outside Site Information
Non-UCSF affiliated site information:
Site name:
South Dakota State University
Contact name:
Nancy L. Fahrenwald, PhD, RN, APHN-BC, FAAN
Email:
Phone:
605-688-5178
For Federally-funded studies only, corresponding FWA#:
 research at this site will be reviewed by:
* The
The non-affiliated site's IRB or a private IRB 
The non-affiliated site is requesting UCSF to be the IRB of 
record for this study 
The non-affiliated site is not engaged in the human subjects 
research and has provided a letter of support 
If the other site's IRB approval letter is available now, attach it to 
the application.  If the IRB approval letter is not yet available, 
submit it once you receive it. 
  
  Or, if the other site is 
 in human subjects 
 
not engaged
research, attach the letter of support to your application.

Outside Site Information
Non-UCSF affiliated site information:
Site name:
North Central Texas Council of Governments
Contact name:
Doni Green
Email:
dgreen@nctcog.org
Phone:
817-640-3300
For Federally-funded studies only, corresponding FWA#:
 research at this site will be reviewed by:
* The
The non-affiliated site's IRB or a private IRB 
The non-affiliated site is requesting UCSF to be the IRB of 
record for this study 
The non-affiliated site is not engaged in the human subjects 
research and has provided a letter of support 
If the other site's IRB approval letter is available now, attach it to 
the application.  If the IRB approval letter is not yet available, 
submit it once you receive it. 
  
  Or, if the other site is 
 in human subjects 
 
not engaged
research, attach the letter of support to your application.
Outside Site Information
Non-UCSF affiliated site information:
Site name:
Area Agency on Aging of North Texas
Contact name:
Rhonda K. Pogue
Email:

Phone:
940-322-5281
For Federally-funded studies only, corresponding FWA#:
 research at this site will be reviewed by:
* The
The non-affiliated site's IRB or a private IRB 
The non-affiliated site is requesting UCSF to be the IRB of 
record for this study 
The non-affiliated site is not engaged in the human subjects 
research and has provided a letter of support 
If the other site's IRB approval letter is available now, attach it to 
the application.  If the IRB approval letter is not yet available, 
submit it once you receive it. 
  
  Or, if the other site is 
 in human subjects 
 
not engaged
research, attach the letter of support to your application.
Outside Site Information
Non-UCSF affiliated site information:
Site name:
Area Agency on Aging of the Panhandle
Contact name:
Melissa Carter
Email:
Phone:
806-331-2227
For Federally-funded studies only, corresponding FWA#:
 research at this site will be reviewed by:
* The
The non-affiliated site's IRB or a private IRB 
The non-affiliated site is requesting UCSF to be the IRB of 
record for this study 
The non-affiliated site is not engaged in the human subjects 
research and has provided a letter of support 

If the other site's IRB approval letter is available now, attach it to 
the application.  If the IRB approval letter is not yet available, 
submit it once you receive it. 
  
  Or, if the other site is 
 in human subjects 
 
not engaged
research, attach the letter of support to your application.
Outside Site Information
Non-UCSF affiliated site information:
Site name:
Area Agency on Aging of Tarrant County
Contact name:
Donald R. Smith
Email:
Phone:
817-258-8000
For Federally-funded studies only, corresponding FWA#:
 research at this site will be reviewed by:
* The
The non-affiliated site's IRB or a private IRB 
The non-affiliated site is requesting UCSF to be the IRB of 
record for this study 
The non-affiliated site is not engaged in the human subjects 
research and has provided a letter of support 
If the other site's IRB approval letter is available now, attach it to 
the application.  If the IRB approval letter is not yet available, 
submit it once you receive it. 
  
  Or, if the other site is 
 in human subjects 
 
not engaged
research, attach the letter of support to your application.
Outside Site Information
Non-UCSF affiliated site information:
Site name:
Texas A&M Center for Population Health and Aging

Contact name:
Marcia Ory, PhD, MPH
Email:
Phone:
979-436-9368
For Federally-funded studies only, corresponding FWA#:
 research at this site will be reviewed by:
* The
The non-affiliated site's IRB or a private IRB 
The non-affiliated site is requesting UCSF to be the IRB of 
record for this study 
The non-affiliated site is not engaged in the human subjects 
research and has provided a letter of support 
If the other site's IRB approval letter is available now, attach it to 
the application.  If the IRB approval letter is not yet available, 
submit it once you receive it. 
  
  Or, if the other site is 
 in human subjects 
 
not engaged
research, attach the letter of support to your application.
Outside Site Information
Non-UCSF affiliated site information:
Site name:
Wisconsin Institute for Healthy Aging
Contact name:
Betsy J. Abramson
Email:
Phone:
608-243-5690
For Federally-funded studies only, corresponding FWA#:
 research at this site will be reviewed by:
* The

The non-affiliated site's IRB or a private IRB 
The non-affiliated site is requesting UCSF to be the IRB of 
record for this study 
The non-affiliated site is not engaged in the human subjects 
research and has provided a letter of support 
If the other site's IRB approval letter is available now, attach it to 
the application.  If the IRB approval letter is not yet available, 
submit it once you receive it. 
  
  Or, if the other site is 
 in human subjects 
 
not engaged
research, attach the letter of support to your application.
Outside Site Information
Non-UCSF affiliated site information:
Site name:
Wyoming Center on Aging University of Wyoming
Contact name:
Christine L. McKibbin, Ph.D.
Email:
Phone:
307-766-2719
For Federally-funded studies only, corresponding FWA#:
 research at this site will be reviewed by:
* The
The non-affiliated site's IRB or a private IRB 
The non-affiliated site is requesting UCSF to be the IRB of 
record for this study 
The non-affiliated site is not engaged in the human subjects 
research and has provided a letter of support 
If the other site's IRB approval letter is available now, attach it to 
the application.  If the IRB approval letter is not yet available, 
submit it once you receive it. 
  
  Or, if the other site is 
 in human subjects 
 
not engaged
research, attach the letter of support to your application.
Outside Site Information

Non-UCSF affiliated site information:
Site name:
Stanford University
Contact name:
Dolores Gallagher-Thompson, Ph.D., ABPP
Email:
Phone:
650-400-8172
For Federally-funded studies only, corresponding FWA#:
 research at this site will be reviewed by:
* The
The non-affiliated site's IRB or a private IRB 
The non-affiliated site is requesting UCSF to be the IRB of 
record for this study 
The non-affiliated site is not engaged in the human subjects 
research and has provided a letter of support 
If the other site's IRB approval letter is available now, attach it to 
the application.  If the IRB approval letter is not yet available, 
submit it once you receive it. 
  
  Or, if the other site is 
 in human subjects 
 
not engaged
research, attach the letter of support to your application.
8.0
 Research Plan and Procedures
8.1  This new consolidated section requests information about:
Hypothesis
Aims
Study Design
Background and Significance
Preliminary Studies
Procedures
Statistical Methods
References
Later sections include:
Drugs and Devices
Sample Size, Eligibility, and Subjects
Recruitment and Consent
Risks and Benefits
Data and Safety Monitoring Plan
Confidentiality, Privacy and Security

Financial Considerations
Qualifications of Personnel
Other Approval and Registrations
8.2  
Describe the hypothesis or what the study hopes to prove 
:
HYPOTHESIS: 
(Help Text updated 9/13)
We propose to conduct a hybrid effectiveness-implementation randomized controlled trial of the B
 online self-management workshop among rural caregivers of partners 
uilding Better Caregivers
with Alzheimer’s disease or other forms of dementia. We hypothesize that stress scores and 
depression symptoms will be significantly improved at 12 months in the intervention vs. control 
group (Aim 1). We also will identify the key strengths (facilitators) and weaknesses (barriers) of 
workshop implementation to characterize its potential to achieve widespread, community-based, 
real-world implementation in rural America (Aim 2).
8.3  
List the specific aims:
AIMS: 
Aim 1: Evaluate the effectiveness of an online self-management workshop for rural 
informal caregivers of individuals with Alzheimer’s disease. We will perform a 12-month 
randomized controlled trial of the 
 workshop by comparing validated 
Building Better Caregivers
self-reported outcomes for participants in the intervention group (n=320) and attention control 
group (n=320) on the primary outcomes of caregiver stress and depression symptoms. Nineteen 
community organizations and three national organizations serving rural communities in 17 states 
have agreed to partner with us on the proposed trial. We will recruit rural dementia caregivers 
from the many rural communities they serve.
Aim 2: Identify key strengths (facilitators) and weaknesses (barriers) of workshop 
implementation. For our implementation evaluation, we will use the RE-AIM framework and a 
mixed methods approach. To identify implementation characteristics pertinent to 
, we 
caregivers
will identify patterns of experience across all workshop participants via analysis of implementation 
questions embedded in trial surveys administered to all participants. To more deeply understand 
these experiences, we will interview a sample of 60 caregivers—15 per US region (West, Midwest, 
Northeast, South). To determine implementation characteristics pertinent to community 
, we will collect data from our partner community organizations on experiences of 
organizations
barriers and facilitators. Analyses will compare and contrast characteristics within and between 
organizations. Findings will identify essential elements of workshop implementation that should be 
incorporated into future implementation efforts. Findings on effective and ineffective strategies 
will inform the implementation of other online programs for rural, caregiver, and Alzheimer’s 
disease populations.
8.4  
Briefly describe the study design (e.g., observational, interventional, randomized, placebo-
DESIGN: 
controlled, blinded, cross-over, cross-sectional, longitudinal, pharmacokinetic, etc.):  
We will recruit 640 rural dementia caregiver adults through 19 community organizations (serving 
rural communities in 17 states to implement a randomized, attention controlled clinical trial. 
Caregivers will be randomized to receive the online intervention (workshop) group or attention 
control group. The online workshops will be facilitated by trained caregivers who will lead 
workshops. We will assess both primary and secondary outcomes at baseline, 1.5 months (post 
intervention), 6 and 12 months, with the main intervention group comparison being at 12 
months. Interested control group caregivers also will be offered the workshop after the trial is 
completed.
Using mixed methods approach we will identify implementation characteristics pertinent to 
caregivers, identify patterns of experience across all workshop participants via analysis of 
implementation questions embedded in trial surveys administered to all participants. To more 
deeply understand these experiences, we will interview a sample of 60 caregivers—15 per US 
region (West, Midwest, Northeast, South).
To determine implementation characteristics pertinent to community organizations, we will collect 
data from our partner community organizations on experiences of barriers and facilitators. 
Analyses will compare and contrast characteristics within and between organizations. Findings will 

identify essential elements of workshop implementation that should be incorporated into future 
implementation efforts. Findings on effective and ineffective strategies will inform the 
implementation of other online programs for rural, caregiver, and Alzheimer’s disease populations.
8.5  
 Briefly provide the background and significance of this study (e.g. 
BACKGROUND AND SIGNIFICANCE:
 
why is this study needed) (space limit: one half page):
Approximately 13 million informal caregivers provide critical support to US adults with Alzheimer’s 
disease and other forms of dementia—enabling them to live safer, healthier, and more fulfilling 
lives in their homes and local communities. Informal caregivers (“caregivers”) are usually unpaid 
family members or friends who help patient care recipients (“partners”) manage their health 
conditions and day-to-day activities. Among dementia caregivers, an estimated 1.4 million live in 
rural areas. These caregivers are particularly vulnerable due to their geographic isolation and the 
well-documented rural disparities in health care access and quality. Many rural caregivers 
experience high levels of stress, depression, and other adverse health consequences due to these 
responsibilities, which can also limit their ability to maintain their caregiving role. Thus, there is a 
pressing need for scalable, accessible programs to support rural dementia caregivers so that they 
can sustain their own well-being and continue to provide care within the home environments of 
their loved ones.
There are several programs for dementia caregivers, but only two have been evaluated among 
rural caregivers, and neither used a randomized study design. In addition, well-established 
dementia caregiver programs (e.g., REACH, COPE, Tele-Savvy) are delivered in-person, one-on-
one (e.g., by phone), or at set times of day, which can diminish uptake by caregivers who live in 
rural areas, cannot leave their partners alone, or have difficulty keeping regular appointments 
during the day when caregiver responsibilities are most intense. Isolated rural dementia 
caregivers also crave social interactions with peers. Online small group programs that are 
accessible at home at any time of day would be an ideal option for many such caregivers.
8.6  
Briefly summarize any preliminary studies relevant to your proposed 
PRELIMINARY STUDIES: 
research 
:
(space limit: one half page)
Our team has developed and pilot tested an online 6-week, highly interactive, small-group self-
management and skills-building workshop for caregivers of loved ones with dementia or cognitive 
impairment. The workshop, called Building Better Caregivers, is based on Self-Efficacy Theory 
boosted by enhanced social support and builds on substantial evidence from other dementia 
caregiver interventions and self-management programs. Every part of the workshop is designed 
to enhance caregiver self-management behaviors, dementia caregiving skills, and peer social 
support. In our evaluations of the program in non-randomized studies, caregivers experienced 
significant improvements in stress, depression symptoms, and self-efficacy (Cohen’s d 
standardized effect size range 0.27-0.70), and partners experienced improved well-being (effect 
size = 0.40). Participation by rural dementia caregivers ranged from 30-50%, and the community 
organizations that partnered with us expressed enthusiasm for expanding the workshop reach to 
a greater number of rural dementia caregivers.
Building on these encouraging preliminary findings, we now propose to conduct a hybrid 
effectiveness-implementation randomized controlled trial of the Building Better Caregivers online 
self-management workshop among rural caregivers of partners with Alzheimer’s disease or other 
forms of dementia. Effectiveness-implementation trials focus a priori on assessing both clinical 
effectiveness and implementation and can therefore reduce time to translation.
8.7  
Is this a treatment study, i.e. does this study intend to provide treatment 
* TREATMENT PROTOCOL: 
to individuals with a medical or psychological condition: (REQUIRED) 
  Yes  
  No
8.8  
 Does this study involve any services or procedures (e.g. physical exams, 
* BILLABLE PROCEDURES:
surgeries, lab tests, imaging studies, or drugs) that could be billable to patients, their insurance, 
Sponsor, or any other entity (answer 'Yes' even if the study is going to pay for all the procedures): 
(REQUIRED) 

  Yes  
  No
If you are not sure if your study involves billable procedures, send an email 
to the 
 for help answering this 
UCSF Office of Clinical Research (OCR)
question.
8.9  
Types of research activities that will be carried out. Check all that 
 COMMON RESEARCH ACTIVITIES: 
*
apply and describe in more detail in the 'Procedures / Methods' section: (REQUIRED)
Interviews, questionnaires, surveys
Educational or cognitive tests
Focus groups
Observation
Non-invasive imaging or testing (MRI, EEG, pulse oximetry, etc.)
Administration of contrast agent
Imaging procedures or treatment procedures that involve radiation (x-rays, CT scans, CT-
guided biopsies, DEXA scans, MUGA or PET scan)
Biopsy conducted solely for research purposes
Use of placebo
Sham surgical procedure
Collection of data from wearable tech such as Fitbit, Apple Watch, Garmin, motion actigraphs, 
etc.)
Fitness tests or other exertion activities
Use of mobile health apps or other apps
Social media-based research activities
None of the above
8.10  
PROCEDURES / METHODS: 
* 
(REQUIRED)
Describe the research methods and study activities taking place at 
each site (e.g. what will participants be asked to do and what will 
members of the study team do?). If there will be multiple 
participant groups or study sites, explain what will happen with 
each group or study sites.
 
If some of the activities would occur even if the person were not in 
the study, as in the case of treatment or tests performed for 
diagnostic purposes, clearly differentiate between those activities 
that will be done solely for research purposes and those that are 
happening as part of routine care.
 
Please call our office at 415-476-1814 and ask to speak to someone on the 
Expedited Review team if you need help differentiating between what parts 
are research and what parts aren't.
For Aim 1-Procedures for RCT.
Only #1 below will be done if a potential participant does not enroll in the study.
1.    
Eligibility will be determined by an anonymous online screening survey. Potential 
Eligibility: 
participants will also be given the option to complete it by mail or phone, if they prefer.  Potential 
participants will be asked their age, gender, to indicate the outreach effort(s) they are responding 
to in which targeted rural communities, followed by the eligibility criteria: caring for patient with 
dementia (PWD); able to read and write in English; able to access the internet; providing care for 
≥ 10 hours per week.

2.    
After confirming eligibility they will read all consent forms (written at 
Informed consent: 
the 6th grade level) online. These will be formatted so that they can print them out if desired. 
They will be offered the opportunity to discuss the study by email or phone with the study 
coordinator or PI. Those comfortable doing so will then complete the online consent form (or a 
mailed hardcopy, if they prefer).
3.    
 Caregivers will be randomized after completion of enrollment and the 
Randomization.
baseline survey (see4a). Staff will inform study participants about treatment assignment by e-
mail or telephone (according to caregiver preference). Caregivers will be randomized to 6-week 
intervention or attention control group.
4.    Activities by group:
a. 
 Participants will receive the Building Better Caregivers 
Intervention group.
workshop.  Building Better Caregivers is an online 6-week, interactive, small-group self-
management, social support, and skills-building workshop developed for caregivers of 
individuals with Alzheimer’s disease or related forms of dementia.  Workshop content 
encompasses two complementary categories—topics that address caregiver self-
management and topics that focus on dementia caregiving skills. Workshops consist of 20-
25 persons. Each week, participants are asked to log on at least 2-3 times for a total time 
of approximately two hours. Activities are guided by two peer co-facilitators (caregivers 
themselves). Caregiver participation does not require “real time” attendance at pre-
determined times.  Caregivers interact in group discussions and person-to-person 
communications by making postings on discussion boards and sending individual 
messages. They can write these at any time of day or night. Such participant interactions 
are frequent and similar to email, Facebook, or texting exchanges. Each week focuses on 
the introduction of 2-3 new topics, with some key topics repeated in subsequent weeks. 
Lessons are then reinforced in the Discussion Center section of the website, where the 
peer social support occurs.
Information on the workshop facilitators:
All facilitators are originally leaders of another onlinee small group workshop called the 
chronic disease self-management program and have completed 4 days of training for that 
program. There are more than 5000 of these people nationwide. Those who are caregivers 
(of persons with dementia or other chronic conditions) and are interested in receiving 
additional training are offered the opportunity to become 
 
Building Better Caregivers
facilitators. They then receive additional training in a series of webinars that familiarize 
them with the workshop and train them to follow the workshop facilitator manual. The 
manual guides them through all workshop topics, activities, and anticipated participant 
interactions. Facilitators must demonstrate mastery of the material. Finally, they co-
facilitator their first workshop with an experienced facilitator and are mentored by an 
experienced trainer. Only after this do they become a fully-qualified facilitator. Canary 
Health (the health technology company that is licensed by Stanford University to 
administer the workshop) already has a robust cadre of these facilitators that guide 
workshops for Veteran caregivers. Facilitators can lead workshops remotely from 
anywhere in the US and are paid to do so. All workshop interactions are recorded on the 
workshop platform, such that fidelity tracking is streamlined. We will use this to perform 
fidelity monitoring in the current study. Dr. Yank and research staff will perform 
intervention fidelity monitoring. We will use a fidelity assessment instrument  to evaluate 
online recordings on a weekly basis. If facilitators stray from the facilitator manual they 
will receive immediate remedial training from Dr. Yank or Dr. Lorig. If they continue to 
depart from the manual they will be removed from their role and another facilitator will be 
brought in to serve as co-facilitator.
Weekly topics that are covered in readings, activities,and discussions include those that 
focus on caregiver self-management and those that focus on dementia caregiving:
Self-management topics
Making an action plan
Problem-solving
Managing stress
Managing difficult emotions
Helpful and unhelpful thinking
Finding ways to relax
Health eating
Physical activity/exercise
Getting a good night's sleep
Improving fatigue

Dementia caregiving topics
Difficult care partner behaviors--how to understand and manage
Getting help inside and outside the home (e.g., adult daycare, in-home care)
Managing medications
Safety concerns (e.g., wandering, driving)
Communication--how to understand and improve
Working with health care systems and providers
Making decisions about medication care (e.g., goals of care)
Planning for the future/legal issues (e.g., durable power of attorney)
Finanial issues (e.g., financial planning, wills)
These topics are covered in the Learning Center, discussed in the Discussion Center, and 
can be reinforced using tools in the My Tools area of the website, which are described 
further below:
The 
 is where participants learn self-management techniques.  Each 
Learning Center
week, new content is made available.  Past weeks’ content also remains 
available.  The Learning Center is self-directed in that participants can control the 
speed and timing of their reading and lessons.
The 
 is interactive and includes four directed bulletin boards where 
Discussion Center
discussions and interaction occur and are facilitated by the trained facilitators: the 
action-planning board, the problem-solving board, the difficult emotions board, and 
the celebrations board.
My Tools is a personal area accessible only by the participant and contains such 
tools as journals, exercise monitoring logs, and medication records.
For intervention group fidelity purposes. All workshop interactions are recorded via 
screen shots on the workshop platform, such that fidelity tracking is streamlined. Dr. 
Yank, Dr. Lorig or research staff will perform intervention fidelity monitoring. We will use 
the fidelity assessment instrument to evaluate online recordings on a weekly basis. If 
facilitators stray from the facilitator manual they will receive immediate remedial training 
from Dr. Lorig or Yank. If they continue to depart from the manual they will be removed 
from their role and another facilitator will be brought in to serve as co-facilitator.
b.  
Participants will receive written materials on dementia and 
Attention control group. 
caregiver resources and two brief phone calls of 15-30 minutes apiece by research 
staff.  Caregivers in the attention control group will be offered the online workshop after 
the 12 month trial is completed if they so desire. The written materials and phone call 
guides are still under development and will be submitted to the IRB for review as a 
modification request.
For control group fidelity purposes. Phone calls will be recorded. Dr. Yank and the 
research coordinator will evaluate recordings using a fidelity assessment instrument. Staff 
who stray from the phone call protocol will receive immediate remedial training. If an RA 
strays from the protocol again, he/she will be removed from making phone calls. At the 
outset of the trial, fidelity assessment will occur approximately every 4-5 calls to assure 
fidelity patterns are quickly established and reinforced. Subsequent checks will occur every 
10-12 calls.
5.    
Data will be collected at baseline, 1.5 months (post intervention), 6 months, 
Assessments: 
and 12 months. Data will be collected through online surveys completed by caregivers and 
conducted at baseline, post-intervention (1.5 months), and 6, and 12 months using the secure 
REDCap application. Assessments are expected to be 20 minutes each. Participants will be given 
the option to complete surveys by mail or phone interview.
a.    
 questions will ask about caregiver and PWD demographic information (e.g., 
Baseline
age, gender, race/ethnicity, education); caregiving relationship to PWD (e.g., spouse, 
child), and resources participants are accessing (e.g., paid in-home care). Baseline 
questions also will identify caregiver and partner chronic conditions (e.g., using the 
Charlson comorbidity index), partner need for assistance with ADLs and IADLs, and 
dementia characteristics (e.g., diagnosis, length of diagnosis, degree of impairment, 
presence of behavioral symptoms). Caregiver (CG) stress level (Stress visual numeric 
scale), CG depression symptoms (PHQ-8 score), Self-efficacy (Revised Scale for Caregiver 
Self-efficacy), Burden (Zarit Burden Inventory), Strain (Caregiver Strain Index), Global 
health score, and Healthcare utilization items.
b.    
. We will administer the Caregiver (CG) stress level (Stress visual 
1.5 months
numeric scale), CG depression symptoms (PHQ-8 score), Self-efficacy (Revised Scale for 
Caregiver Self-efficacy), Burden (Zarit Burden Inventory), Strain (Caregiver Strain Index), 
Global health score, and Healthcare utilization items. For participants randomized to the 

intervention group will be given additional questions on Reach (e.g., how heard about 
trial, reasons for participation); Implementation (e.g., ease of/barriers to logging into 
workshop and performing online activities, whether completed the workshop and, if not, 
why not); and Maintenance (e.g., whether workshop experiences have continued to 
influence their self-care or caregiving practices or own/partner’s health).
c.     
. We will administer the Caregiver (CG) stress level (Stress visual numeric 
6 months
scale), CG depression symptoms (PHQ-8 score), Self-efficacy (Revised Scale for Caregiver 
Self-efficacy), Burden (Zarit Burden Inventory), Strain (Caregiver Strain Index), Global 
health score, and Healthcare utilization items.  For participants randomized to the 
intervention group will be given additional questions on Reach (e.g., how heard about 
trial, reasons for participation); Implementation (e.g., ease of/barriers to logging into 
workshop and performing online activities, whether completed the workshop and, if not, 
why not); and Maintenance (e.g., whether workshop experiences have continued to 
influence their self-care or caregiving practices or own/partner’s health).
d.    
. We will administer the Caregiver (CG) stress level (Stress visual numeric 
12 months
scale), CG depression symptoms (PHQ-8 score), Self-efficacy (Revised Scale for Caregiver 
Self-efficacy), Burden (Zarit Burden Inventory), Strain (Caregiver Strain Index), Global 
health score, and Healthcare utilization items. For participants randomized to the 
intervention group will be given additional questions on Reach (e.g., how heard about 
trial, reasons for participation); Implementation (e.g., ease of/barriers to logging into 
workshop and performing online activities, whether completed the workshop and, if not, 
why not); and Maintenance (e.g., whether workshop experiences have continued to 
influence their self-care or caregiving practices or own/partner’s health).
For Aim 2-Procedures for In-depth Interviews.
We will randomly select a sub-set of intervention group caregivers for semi-structured telephone 
interviews regarding workshop implementation characteristics. We will sample for caregivers 
(n=60 total) from all US regions (n=15 per region—West, Midwest, South, Northeast) to achieve 
the expected saturation of themes within 12-15 interviews/region.
In the 30-minute telephone interview we will probe for deeper understanding of the caregiver’s 
impressions of and responses to the workshop. Interviews will be audiorecorded and electronically 
stored on secure computers. Following each interview, the interviewer will write a summary of the 
content of the interview to assist with subsequent analysis of audiorecordings. Professionals will 
transcribe and anonymize recordings.
Interviewers will ask caregivers questions about workshop Implementation and Maintenance (e.
g., What helped you be able to participate in the workshop? Are there other things that would 
have made it easier for you?, What got in the way of your participation in the workshop? Can you 
describe things that would help you overcome these problems?, What workshop activities did you 
participate in and why did you? What activities did you not participate in and why not?, What 
aspects of the workshop most impacted your caregiving? What workshop lessons or skills have 
you continued to use?, Can you describe the impact the workshop has had on you or your 
partner?).
For Aim 1 and 2-Procedures for Learning Collaborative.
We will establish a Learning Collaborative for our participating community organizations. The 
Learning Collaborative will enable efficient collection of implementation data, while simultaneously 
promoting regional and national networking and peer-to-peer learning among organizations 
serving similar populations of rural caregivers and PWD. Activities will span Years 1-5.
The Learning collaborative will consist of biannual 90-minute webinars and a longitudinal list-
serve to promote discussion and information exchange. All webinars will have a similar structure. 
Dr. Yank will facilitate these. The first half will be devoted to a discussion of aspects of workshop 
implementation. We also will track the use of different outreach strategies and subsequent 
successful (or unsuccessful) recruitment to inform future implementation efforts. The second half 
of the webinars will include lectures on and discussion of caregiving and Alzheimer’s disease 
topics relevant to the organizations. Organizations will be invited to nominate topics and speakers 
during study Year 1 and on an ad hoc basis subsequently.  Some webinars may be audio recorded 
for note purposes.
In addition, members will use a list-serve for learning from each other (e.g., discussing 
challenges, exchanging tips). Periodically, the research team will make posts to the list-serve to 
prompt group discussion of specific implementation questions, concerns, or success stories.  We 
will also ask for descriptive data related to their organization.

8.12  
List all questionnaires, surveys, interview, or focus group guides that will be used for 
INSTRUMENTS: 
this study:
If the instruments are not complete or not available because they 
will be developed as part of this study, describe the basic content or 
include an outline and submit the final versions to the IRB with a 
modification for approval prior to use.
Aim 1 Instrument.
Descriptive variables.
Baseline questions will ask about caregiver and patient with dementia (PWD) demographic 
information (e.g., age, gender, race/ethnicity, education);
caregiving relationship to PWD (e.g., spouse, child),
resources participants are accessing (e.g., paid in-home care).
 caregiver and PWD chronic conditions (e.g., using the Charlson comorbidity index),
PWD need for assistance with Activities of Daily Living (ADLs) and Instrumental Activities 
of Daily Living (IADLs),
 PWD dementia characteristics (e.g., diagnosis, length of diagnosis, degree of impairment, 
presence of behavioral symptoms).
Primary outcomes.
Caregivers describe high personal stress as one of the most challenging aspects of being a 
caregiver. We will use a single-item visual numeric scale (range 1-10) developed by our 
team. Visual numeric scales [VNS] have been shown to correlate well [r = .72] with same-
worded visual analogue scales [VAS] and generate higher completion rates.
 We will measure the co-primary outcome of caregiver depression symptoms with an 8-
item modified and validated version of the PHQ-9.
Secondary outcomes.
Self-efficacy will be measured with the 15-item Caregiver Self-Efficacy scale.
Caregiving burden will be assessed with the 12-item short form of the Zarit Burden 
Inventory.
The modified 13-item Caregiver Strain Index will measures caregiver strain.
Single-item caregiver-reported data will be collected on caregiver and PWD global health, 
hospitalizations, and emergency room visits.
We will use the National Health and Nutrition Survey question on global health.
We will measure healthcare utilization using single-item questions on hospitalizations and 
emergency room visits that have been demonstrated in multiple studies to be reliable 
within the 6-month recall time frame we are using, including among dementia caregivers.
For intervetion arm only: We will embed implementation questions administered to all 
intervention group caregivers at baseline and months 1.5, 6, and 12. Questions will ask about 
various aspects (e.g., how heard about trial, reasons for participation, ease of/barriers to logging 
into workshop and performing online activities, whether completed the workshop and, if not, why 
not; whether workshop experiences have continued to influence their self-care or caregiving 
practices or own/partner’s health).
 
Fidelity monitoring assessment. We will use the fidelity assessment instrument from pilot 
studies to evaluate online recordings on a weekly basis for the intervention group. Similarly, we 
will use a fidelity assessment instrument to evaluate phone calls for the attention control group.
 
Aim 2 Instrument.
We will develop an instrument that will be adminsted to a randomly selected sub-set of 
intervention group caregivers for semi-structured telephone interviews regarding workshop 
implementation characteristics. We will probe for deeper understanding of the caregiver’s 
impressions of and responses to the workshop. This instrument will ask caregivers questions 
about workshop 
 and 
. 
 (e.g., ease of/barriers to 
Implementation
Maintenance Implementation
logging into workshop and performing online activities, whether completed the workshop and, if 
not, why not) and 
 (e.g., whether workshop experiences have continued to influence 
Maintenance
their self-care or caregiving practices or own/partner’s health).
 

Aim 1 and 2 Learning Collaborative Instrument.
We will collect descriptive information about our partner agencies (e.g., rural region covered, 
agency type, caregiver services provided, etc.)
Attach any unpublished instruments in the 'Other Study Documents' 
section of the Initial Review Submission Packet form after 
completing the study application. Published instruments should 
NOT be attached.
8.13  
Are you drawing any blood or collecting other biosamples (e.g. tissue, 
* BIOSPECIMEN COLLECTION: 
buccal swabs, urine, saliva, hair, etc.): (REQUIRED)
  Yes  
  No
8.26  
Briefly summarize the methods and types of analyses that will be 
STATISTICAL METHODS: 
performed:
Aim 1 Data Analysis Methods.
Descriptive analyses. Caregiver and caregiver-reported partner socio-demographic 
characteristics, chronic conditions, and health utilization outcomes will be summarized as means 
(±SD), frequencies, percentages, and 95% confidence intervals at baseline and 1.5, 6, and 12 
months. The distributions of covariates at baseline will be checked for balance between the two 
groups with histograms and/or boxplots.
Primary analyses. Primary analyses will compare caregiver stress (stress score) and depression 
symptoms (PHQ-8 score) between intervention and control groups over time with respective 
linear mixed effects models. Linear mixed effects models use all available observations in the 
data, assume data are missing at random, and provide an intention-to-treat analysis. Models will 
include group, time, and (group*time) interaction terms as fixed effects and community 
organizations and subjects as random effects to account for the correlation within organizations 
and subjects due to measurements over time. Covariates with imbalanced distributions between 
the two groups will also be included in the models to control for potential confounding. The 
(group*time) interaction term will be used to evaluate if the two groups differ in outcomes over 
time. The study is powered to allow 30% loss to follow up. To assess for potential differential 
withdrawal between groups, comparisons of withdrawal rates and time to withdrawal will be 
performed. Models based on a potential outcome framework will be used to assess treatment 
effect while accounting for noncompliance and missing data and to examine potential treatment 
mechanisms/pathways via intermediate variables (such as social support, self-efficacy, caregiving 
skills). Multiple imputation based on reasonable assumptions on mechanisms of missing data will 
be used to perform sensitivity analyses.
Secondary analyses. Secondary analyses will use (generalized) linear mixed effect models 
similar to the primary mixed effect models for continuous, categorical, and count secondary 
outcomes. Treatment effects in subgroups (e.g. by sex) of our interest will be evaluated using 
(generalized) linear mixed effect models with corresponding interactions of group, time and sex 
while controlling for false discovery rate. We expect a small and balanced recall error between the 
two groups but if recall error is unbalanced, measurement error models will be considered for 
treatment evaluation. We will examine loss to follow-up by comparing caregivers lost to follow-up 
to those who complete the study.   
 
Aim 2 Data Analysis Methods.
We will use mixed methods and multiple data sources to generate findings. We will identify 
facilitators and barriers of workshop implementation pertinent to caregivers.
Data analyses using all intervention caregivers' : We will embed implementation questions 
in the web-based trial surveys administered to all intervention group caregivers at baseline and 
months 1.5, 6, and 12.  We will perform descriptive and comparative analyses of the survey-
based and platform-derived data to identify notable barriers and facilitators of workshop 
implementation for intervention group caregivers. For example, we will analyze participation rate 
by caregiver sub-groups (e.g., region, age, gender, race/ethnicity). Findings will identify the 
degree to which 
 successfully achieves the Reach, Implementation, and 
Building Better Caregivers
Maintenance domains of RE-AIM for caregivers.

1.  
2.  
3.  
4.  
5.  
Data analyses using a subest of intervention caregivers: We will sample for caregivers 
(n=60 total) from all US regions (n=15 per region—West, Midwest, South, Northeast) to achieve 
the expected saturation of themes within 12-15 interviews/region. Using data collected through 
telephone-based 30 minute interviews we will probe for deeper understanding of the caregiver’s 
impressions of and responses to the workshop. Interviews will be audiorecorded and electronically 
stored on secure computers. Professionals will transcribe and anonymize recordings. A code key 
linking transcripts to participants will be kept in a secure electronic file accessible to only the 
study PI and research coordinator.  Data analysis will be conducted concurrently with ongoing 
data collection to ensure timely generation of findings. Interview transcripts and summary notes 
will be uploaded into NVivo qualitative data management and analysis software.  Using NVivo the 
coding team will perform thematic analysis of interview transcripts. The coding team will consist 
of the research coordinator and RA. They will read each transcript and assign codes to identify 
emergent themes and also apply 
deductive codes derived from the RE-AIM framework. 
a priori 
After coding approximately 6-7 transcripts, the coding team will convene with Drs. Yank and 
Chesla (investigators with qualitative research expertise) to compare and discuss individual styles 
of coding and approaches to achieve coding consistency and begin to identify among emergent 
codes whether there are relevant sub-codes to be agreed upon. The coding team and 
investigators will meet for a similar discussion following coding of an additional 6-7 transcripts to 
assure consistency. After coding is completed, the same group will convene, discuss, and reach 
consensus on interview themes, qualitative findings, and illustrative quotes.
8.27  
(a separate bibliography can be attached 
REFERENCES: List only the 5-10 most relevant references 
for reference purposes if this study involves novel approaches, agents, or an emerging technology 
that the IRB may not be familiar with):
Lorig K, Thompson-Gallagher D, Traylor L, et al. Building Better Caregivers: a pilot online 
support workshop for family caregivers of cognitively impaired adults. Journal of Applied 
2012;31:423-437. http://journals.sagepub.com/doi/10.1177
Gerontology. 
/0733464810389806
Lorig K, Ritter PL, Laurent DD, Yank V. Building Better Caregivers:  A pragmatic 12-month 
trial of a community-based workshop for caregivers of cognitively impaired adults. J 
Applied Gerontol. 2017 Nov 1:733464817741682. doi: 10.1177/0733464817741682.
Ma J, Yank V, Xiao L, et al. Translating the Diabetes Prevention Program Lifestyle 
Intervention into primary care:  A randomized trial. 
2013;173:113-121. 
JAMA Intern Med. 
PMCID: PMC3856315.
Fitzgerald JD, Johnson L, Hire DG, et al. Association of objectively-measured physical 
activity with cardiovascular risk in mobility-limited older adults. 
2015;
J Amer Heart Assoc. 
4(2):pii: e001288. PMCID: PMC4345863.
Yank V, Tribett E, Green L, Pettis J. Learning from marketing: rapid development of 
medication messages that engage patients. 
2015;98:
Patient education and counseling. 
1025-1024. PMCID: PMC4684954.
9.0
 Drugs and Devices
9.1  
Are you 
 any drugs and/or biologics that are either 
* DRUGS AND/OR BIOLOGICS: 
STUDYING
approved or unapproved: (REQUIRED)
  Yes  
  No
9.3  
: Are you 
 any medical devices, in vitro diagnostics, or assays that are 
* MEDICAL DEVICES
STUDYING
 
either approved or unapproved:(REQUIRED)
  Yes  
  No
10.0
 Sample Size and Eligibility Criteria
10.1  
 
How many people will you enroll:
ENROLLMENT TARGET: 

678
 If there are multiple participant groups, indicate how many people will be 
in each group:
For Aim 1 Sample for RCT. We will recruit 640 rural dementia caregiver adults through 19 
community organizations (serving rural communities in 17 states to implement a randomized, 
attention controlled clinical trial. 320 in the intervention group and 320 in the control group for a 
total of n=640.
 
For Aim 2 Sample for In-depth Interviews. We will randomly select a sub-set of intervention 
group caregivers for semi-structured telephone interviews regarding workshop implementation 
characteristics. We will sample for caregivers (n=60 total) from all US regions (n=15 per region—
West, Midwest, South, Northeast).
 
For Aim 1 and Aim 2 Sample for Learning Collaborative. 19 community organizations 
(serving rural communities in 17 states) will have at most 2 representatives participating in the 
Learning Collaborative (n=2*19=38).
10.3  
Explain how and why the number of people was chosen. For multi-site 
SAMPLE SIZE JUSTIFICATION: 
studies, this is referring to the number that will be enrolled across all sites:
The study is powered on the co-primary outcome with the lowest effect size in pilot studies—the 
PHQ-8 depression symptoms score (effect size 0.27). We will use a recruitment target of 640 
participants. We assume 30% loss to follow-up, thus expecting 448 caregivers (224 per group) 
will complete the study at 12 months.  This sample size of 448 will allow us to detect a PHQ-8 
effect size of 0.265 with a power of 0.8 at a significance level of 0.05 (two-sided). The effect size 
of 0.265 corresponds to a 1.5 difference in PHQ-8 score (range 0-24) between groups assuming a 
common standard deviation of 5.6.  We also will have the power to detect a 1.4 difference in the 
co-primary outcome of stress score (range 0-10) between the two groups.
If we encounter problems meeting trial enrollment benchmarks, we will work with local 
organizations and others to find alternative recruitment strategies such as health system-based 
patient portals or recruitment through national caregiver discussion groups.  We also can add 
additional partner organizations after the start of the study.
10.4  
Eligible age ranges: 
* 
 AGE RANGE: 
PARTICIPANT
(REQUIRED)
0-6 years
7-12 years
13-17 years
18-64 years
65+
10.5  
 Data will be collected from or about the following types of people (check all 
STUDY POPULATIONS:
* 
 
that apply): (REQUIRED)
Inpatients
Outpatients
Family members or caregivers
Providers
People who have a condition but who are not being seen as patients
Healthy volunteers
Students
Staff of UCSF or affiliated institutions
None of the above

10.6  
Check the populations that may be enrolled: 
SPECIAL SUBJECT GROUPS: 
* 
(REQUIRED)
Children / Minors
Subjects unable to consent for themselves
Subjects unable to consent for themselves (emergency setting)
Subjects with diminished capacity to consent
Subjects unable to read, speak or understand English
Pregnant women
Fetuses
Neonates
Prisoners
Economically or educationally disadvantaged persons
None of the above
10.7  
 Briefly describe the population(s) that will be involved in this study. Include 
INCLUSION CRITERIA: 
anyone that data will be collected from or about (e.g. patients, healthy controls, caregivers, 
providers, administrators, students, parents, family members, etc.):
For Aim 1 RCT Sample Inclusion Criteria. We will include participants 1) who are 18 years or 
older, 2) responding to outreach efforts in targeted rural communities, 3) caring for person with 
dementia (PWD), 4) able to read and write in English, 5) able to access the internet, and 6) 
providing care for ≥ 10 hours per week*.
 
*We define “care” as the full range of caregiving activities, rather than a specific sub-set, because 
national data indicate that most caregivers perform a mixture of tasks.  Caregivers performing 
medium-to-high burden care do so for, on average, ≥ 10 hours/week, assist with ≥ 2 activities of 
daily living (ADLs) (e.g., dressing) and ≥ 4 instrumental ADLs (e.g., meal preparation), and 
perform medical tasks, health care coordination, and advocacy.  The time threshold of ≥ 10 hours
/week is therefore pragmatic, similar to criteria used in other studies, and will identify caregivers 
experiencing higher burden—those at increased risk for poor personal health outcomes and thus 
most likely to benefit from the intervention.
 
For Aim 2 Sample Inclusion Criteria for debriefing interviews with caregivers, must have 
Building Better Caregivers workshop.
participated in the 
 
For Aim 1 and 2 Sample Inclusion Criteria for Learning Collaborative participation are  :
community member within a community organization that is participating in the Learning 
Collaborative.
10.8  
 List any exclusion criteria (e.g. reasons why someone would not be included 
EXCLUSION CRITERIA:
in the study):
For Aim 1 RCT Sample Exclusion Criteria. We will exclude participants who 1) have an 
anticipated inability to complete the 12-month follow-up (e.g., planned travel), 2) partner living 
in a skilled nursing or similar facility, and 3) zip code of residence not a US-Census defined rural 
region.
10.9    
Do any study activities take place on patient 
* RESEARCH CONDUCTED ON PATIENT CARE WARDS: 
  
care units at UCSF medical facilities: (REQUIRED)  
  Yes  
  No
11.0
 Recruitment and Consent
11.1  
 
What kinds of methods will be used to identify potential participants for 
* RECRUITMENT METHODS: 
recruitment (check all that apply): (REQUIRED)

Medical records review
Recruitment registry
Re-contact of participants from the investigators' previous studies
Referrals from colleagues (attach the 'Dear Colleague' letter or other recruitment materials 
you will provide to colleagues)
Referrals from the community / word of mouth
Advertisements (flyers, brochures, radio or t.v. ads, posting on clinical research sites or social 
media, presentation of the study at community events/media, etc.)
Online recruiting tool such as TrialSpark
CTSI Recruitment Services unit
Other method (describe below)
Attach your recruitment materials (e.g., flyers, ads, recruitment 
letter templates, email text, etc.) in the Other Study Documents 
section of the Initial Review Submission Packet Form.
11.3  
How, when, and by whom will eligibility for recruitment be 
DETERMINATION OF ELIGIBILITY: 
determined:
Caregiver self-assessed anonymous eligibility screening will occur on the website prior to the 
verbal consent (by phone) and randomization. The following will be asked on the online screener 
form to determine eligibility: age 18 years or older; responding to outreach efforts in targeted 
rural communities; caring for patient with dementia (PWD); able to read and write in English; 
able to access the internet; providing care for ≥ 10 hours per week. If  the online screening form 
indicates that the person is eligible for participation in the study, it will provide the potential 
participant with a copy of the RCT study consent form and also for his/her contact information in 
order to arrange a phone call to perform verbal consent by phone for the RCT study. (Please also 
see attachment Online consent and screener for the details.)
11.4  
Who initiates contact (check all that apply): 
INITIATION OF CONTACT: 
* 
(REQUIRED)
Investigators/study team
UCSF recruitment unit (e.g. CTSI Consultation Services)
Potential participant
Other (explain below)
11.5  
 (check all that apply): 
HOW IS CONTACT INITIATED:
* 
(REQUIRED)
In person
Phone
Letter / email
Website or app
Other (explain below)
Attach the telephone recruitment script in the Other Study 
Documents section of the Initial Review Submission Packet Form. If 
potential participants will initiate contact, attach the telephone 
screening script that will be used to provide more information about 
the study and determine if callers are eligible to participate.
Attach the recruitment letter or email template in the Other Study 
Documents section of the Initial Review Submission Packet Form.

Provide the URL for any website in Recruitment Plan section, or 
attach a mock-up of the website or the app screens in the Other 
Study Documents section of the Initial Review Submission Packet 
Form.
11.6  
Based on the checkboxes you chose above, please provide a narrative 
RECRUITMENT PLAN: 
describing your recruitment plan. We want to know:
Who is conducting the search for potential participants, and how?
How are potential subjects being approached for recruitment? By whom, and when?
If there will be more than one participant group (e.g. patients, healthy controls, caregivers, family 
members, providers, etc.), provide details about the recruitment plans for each group. 
(Recommended length - 100-250 words)
We will use multiple recruitment methods, such as: 
Direct communications with local organizations, spiritual centers, and others. We will send 
mail and emails and make telephone calls to local senior centers, health centers, senior 
meal providers, ministerial associations, centers of worship, rural service associations, and 
Area Agencies on Aging.
Print media: We will produce brochures and posters and mail them to the local groups 
described above. We will telephone these sites to ensure receipt and that supplies are 
replenished.
Traditional news media: We will write and pay for advertisements, press releases, and 
public service announcements to be included in local radio and television stations and 
newspapers.
Online media: We will generate content for local organizations to insert into emails they 
send to their communities and pay for postings on local/regional social media sites and 
web sites (e.g., Craigslist).
We will also ask community partners within the targeted rural areas to help disseminate 
information about the study.
11.7  
How will permission to participate (i.e., informed consent) be obtained from 
CONSENT METHODS: 
* 
each potential participant. If there will be multiple groups and different plans for consenting each, 
  
check all that apply. See the orange Help bubble to the right for more detailed guidance.  
 
Participants will (check all that apply): (REQUIRED)
Sign a consent form at the end of the consent discussion (signed consent)
Provide online 'eConsent' using DocuSign or another E-Signature system
Click through a link in a survey or email after reading about the study and then complete the 
study online (electronic consent)
Be told about the study and be given a handout/information sheet and be asked if they agree 
to participate (verbal consent)
Complete the study activities and turn in materials, as in the case of a completed survey that 
is placed in a drop box or mailed to the study team (implied consent)
Not be able to provide consent and will have a family member consent for them, as in the 
case of a critically ill or unconscious patient (surrogate consent)
Not be able to provide consent (emergency waiver of consent - allowed for minimal risk 
research or greater than minimal risk research with an approved community consultation plan)
Not know about the study, as in the case of chart reviews or observations of public behavior 
(waiver of consent)
Other method (describe below)
Attach your consent form, information sheet, or electronic consent 
text in the Informed Consent Documents section of the Initial 
Review Submission Packet Form.
11.8  

Describe the process for obtaining informed consent, including details such as 
CONSENT PROCESS: 
* 
who will have the consent discussion and when participants will be asked to sign the consent form in 
relation to finding out about the study: (REQUIRED)        
 
We encourage researchers to review our 
   
.
guidance on obtaining and documenting informed consent
If there are multiple groups being consented differently, provide details about the consent 
process for each group.
If you are relying on 
, provide details about how that will happen.
verbal or implied consent
For studies using online recruitment and consent or consent via mail, provide details here.
For Aim 1 Consent for RCT.  Once eligibility is determined interested caregivers will have the 
opportunity to enroll.  First, they will read all informed consent information (written at the 6
 
th
grade level) online or by printing a copy from online. The consent information will be formatted to 
be easily printed and  read as paper copies if desired. If caregivers prefer, they will have the 
option of having study personnel send them the consent information sheet by email or in the 
paper post. Interested caregivers will be scheduled for a phone-based informed consent 
discussion with qualified study personnel. During that call the study personnel will review the 
informed consent information sheet out loud, conduct a discussion of it with the potential 
participant, and address all questions or concerns. At such time as the caregivers confirm 
that their questions or concerns have been met and the study personnel determines the caregiver 
understands the study and consent process, study personnel will then obtain verbal 
consent. Caregivers will verbally indicate that they consent ot participate in the study at that time 
during the phone call. This will be considered to be verbal informed consent to participate. Once 
verbal consent is obtained we will mail them a copy of the information sheet.
For Aim 2 debriefing interviews. For the intervention group caregivers who are randomly 
selected for the semi-structured telephone interviews regarding workshop implementation 
characteristics. The research staff will explain over the telephone the purpose of the interview, 
review the informed consent information sheet out loud, address any questions or concerns 
participants may have, and obtain verbal informed consent prior to beginning the 
interview.  Once verbal consent is obtained we will mail them a copy of the information sheet.
For Aim 1 and 2 Learning Collaborative. For the members of the partner community sites who 
have agreed to partner with us in this study, the research staff will explain over the phone the 
purpose of the biannual webinars (to provide input on recruitment preferences for the caregivers 
they serve, and their experience with implementing and maintaining the Building Better 
Caregivers online workshop and your suggestions for improving it) community members will be 
told that some webinars will be audiorecorded and notes will be taken by research staff. These 
will be electronically stored on secure computers, answer any questions community members 
may have, read the information sheet out loud, and obtain verbal informed consent prior to their 
participation in the webinars.  Once verbal consent is obtained we will mail them a copy of the 
information sheet.
 It is important that the people obtaining consent are qualified to do so. 
*
Briefly describe the training and experience these individuals have in 
obtaining informed consent: (REQUIRED)
For Aim 1  RCT (participatns who prefer to do verbal consent process by phone) and for 
Aim 2 debriefing interviews.
For the telephone surveys, an experienced staff member will obtain verbal informed consent by 
utilizing a low-literacy script to explain the purpose interview (learn more about their experience 
in the intervention), answer any questions or concerns, and ask explicitly if the potential 
participant agrees to participate in the relevant portion of the project under questions (RCT 
or one-time 30-minute phone interview for Aim 2 ).  The interviewer will ask questions to make 
sure that the participant has understood the information.
For Aim 1 and 2 Learning Collaborative. For the Learning Collaborative, the PI or experienced 
research staff will obtain verbal informed consent by utilizing a low-literacy script to explain the 
purpose interview (learn more about their experience implementing the intervention, recruitment, 
etc.), answer any questions, and ask explicitly if the potential participant agrees to participate in 
the webinars and that some may be audio recorded.  The PI or research staff will ask questions to 
make sure that they have understood the information.

11.9  
Indicate how the study team will assess and enhance the subjects' 
CONSENT COMPREHENSION: 
* 
understanding of study procedures, risks, and benefits prior to signing the consent form (check all 
that apply): (REQUIRED)        
 
Tip: Review the Consent Comprehension - Learning Notes in the Help 
bubble at the right for specific questions that can be asked to assess comprehension, consider using 
the UCSF Decision-Making Capacity Assesment Tool, and review our guidance on obtaining written or 
 
verbal informed consent for more detail on how to conduct the assessment.
The study team will engage the potential participant in a dialogue, using open-ended 
questions about the nature of the study or the experimental treatment, the risks and benefits 
of participating, and the voluntary nature of participation
Potential participants will be asked or shown a series of questions to assess their 
understanding of the study purpose, procedures, risks and benefits, as well as the voluntary 
nature of participation (especially appropriate when the consent process happens online or 
through a mobile health app)
Other method (describe below):
Provide details of the other approaches that will be used, if using another 
method to assess comprehension:
Aim 1 RCT
 
The study interviewers have extensive experience in obtaining informed consent. Interviewers are 
trained to provide the participant with ample opportunity to have their questions answered, read 
all informed consent elements out loud, and confirm with the participant that the information has 
been understood. They will ask participants to verify that they have understood the critical 
elements of informed consent (e.g., risks, benefits, what is involved, voluntary nature) by asking 
them to repeat back what they understood about the consent form. The interviewers are well-
trained to address any questions and clarify any points, which the potential participant may have 
misunderstood.
11.10  
Does this study rely on some deception or misinformation about what the 
* DECEPTION: 
researchers are observing to get valid data? (REQUIRED)
  Yes  
  No
11.12  
Select the regulatory category under which 
* WAIVER OF DOCUMENTATION OF SIGNED CONSENT: 
the IRB may waive the requirement to obtain 
consent for this study:
signed 
The only record linking the subject and the research would be the consent document and the 
principal risk would be potential harm resulting from a breach of confidentiality. Each subject 
will be asked whether they want documentation linking them with the research. 46.117(c) 
(1)  
The research presents no more than minimal risk of harm to subjects and involves no 
procedures for which written consent is normally required outside of the research context. 
46.117(c) (2)  
11.13  
What is the estimated time commitment for participants (per visit and in total):
TIME: 
Study assessments will include (total time = 80 minutes):
Baseline online survey: 20 minutes
1.5-month online survey: 20 minutes
6-month online survey: 20 minutes
12-month online survey: 20 minutes
 

Study eligibility survey: 5-10 minutes
 
Frequency and duration of intervention group. Workshops run for 6 weeks. Each week, 
participants are asked to log on at least 2-3 times for a total time of approximately two hours. 
Caregiver participation does not require “real time” attendance at pre-determined times. (total 
time 120 minutes x 6 = 720 minutes or 12 hours over 12 months). 
 
Frequency and duration of control group. Participants will participate in two brief phone calls of 
15-30 minutes apiece. (total time 15-30 minutes x 2 = 30 - 60 minutes or .5 to 1 hour over 12 
months)
 
Total eligibility + assessment time = 85 – 90 minutes over 12 months
 
Total for debriefing interview. Those who are randomly selected to complete the phone 30 minute 
interview. (total time 30 minutes)
 
Total for learning collaborative 2x90=180 minutes x 5 years = 900 minutes or 15 hours + 5 
hours of phone calls. Total hours 20 hours
IMPORTANT TIP: Ensure this information is consistent with the 
information provided in the consent form.
11.16  
Describe other alternatives to study participation, if any, that are available 
OTHER ALTERNATIVES: 
to prospective subjects:
This study does not involve treatment and does not have any significant impact on subject’s 
concurrent or future care, the alternative is simply not to participate in this study.
12.0
 Risks and Benefits
12.1  
Check if your study involves any of these specific research-related risks 
RESEARCH-RELATED RISKS: 
to participants that may need to be disclosed in the consent form:
Physical discomforts or pain
Risks to employment, or social or legal standing
Possible personal discomfort due to sensitive topics (stress, embarassment, trauma)
Risk that the study team may observe possible evidence of child abuse, elder abuse, or a 
threat to self or others that they are required to report
For any boxes checked above, describe how you will minimize these risks 
* 
and discomforts, e.g., adding or increasing the frequency 
of monitoring, additional screening to identify and exclude people with 
diminished kidney or liver function, or modification of procedures such as 
changing imaging studies to avoid giving contrast agent to people who are 
more likely to suffer side effects from it, etc.: (REQUIRED)
This is a behavioral intervention with minimal risks.
Potential risks for caregivers taking part in the study may make respondents feel uncomfortable, 
upset or other emotional responses as a result of answering survey questions or during the 
interview, but they can refuse to answer or stop the interview at any time.  

There is also a risk of loss of confidentiality. We will take steps to protect the privacy of patient 
information, however we cannot guarantee total privacy. All participant data will be coded in a 
confidential manner that will protect the identity of the participant. Participants will be assigned a 
unique identifier, and all data entered into the study database will only utilize this identifier. A list 
of the participant names and the associated codes will be stored on a secured encrypted 
server.   All study-specific data files will be kept on secure servers that are password-protected 
and shielded from unauthorized access by firewalls. Only key study personnel will have access.
There is also slight risks for participating in the online workshop intervention (for those who are 
randomized to receive the Building Better Caregivers workshop initially or who choose to attend it 
later after the trial is completey (control group participants)). Because workshops consist of 20-
25 persons and run for 6 weeks. Each week, participants are asked to log on at least 2-3 times 
for a total time of approximately two hours. Activities are guided by two peer co-facilitators 
(caregivers themselves). Caregiver participation does not require “real time” attendance at pre-
determined times. Instead, caregivers interact in group discussions and person-to-person 
communications by making postings on discussion boards and sending individual messages. They 
can write these at any time of day or night. Participants may respond to workshop modules by 
experiencing and/or disclosing their experiences of stress and difficult emotions. The workshops 
are facilitated by peer facilitators who receive rigorous training on the management and triage of 
participants experiencing difficult emotions, which includes when and how to activate built-in 
safety protocols—such as contact of the overseeing health professional if a participant indicates 
they are at any risk for self-harm. Facilitators keep track of all participants by electronically 
checking in with them at least once weekly during the 6-week workshop. They also observe all 
online interactions and postings daily throughout the workshop. The activities of the facilitators 
are themselves reviewed by “Master Trainers” who monitor the fidelity, quality, and safety of 
workshop delivery. Workshop participants also receive training on how to contact their workshop 
facilitators.
12.2  
Describe any anticipated risks and discomforts not listed above:
RISKS: 
see section 12.1 above.
12.3  
MINIMIZING RISKS: Describe the steps you have taken to minimize the risks/discomforts to 
subjects. Examples include:
designing the study to make use of procedures involving less risk when appropriate
minimizing study procedures by taking advantage of clinical procedures conducted on the 
study participants
mitigating risks by planning special monitoring or conducting supportive interventions for the 
study
having a plan for evaluation and possible referral of subjects who report suicidal ideation
Efforts to provide protection against risks will occur during all stages of the project. Prior to 
enrollment, the study investigators will explain the study in a clear manner, using language at a 
6th grade level. We will attempt to make our informed consent forms at an 6th grade reading 
level and used bulleted formats to enhance comprehensibility of the forms for persons with lower 
educational levels. Participants will be given several opportunities to ask questions. To prevent 
the perception of coercion to participate, study investigators and research staff will inform the 
participants that they can drop out of the study at any time, and dropping out of the study will 
not affect the services they receive through our partner community organizations. A copy of the 
consent form will be given to the participant (online or by mail). The consent form will have 
contact information for both the study Principal Investigator (PI) and the IRB if they have any 
questions or concerns.
The Research Assistant (RA) will be trained by Dr. Yank, the PI, who is a self-management expert 
and practicing primary care physician, with expertise in chronic disease management and 
caregiver and self-management research.  In the course of the study, we will have several 
safeguards in place to quickly identify and respond to participants who we feel might require 
professional mental health assessment and services or other forms of medical assessment or 
care. To decrease the likelihood of an adverse event during the study, the RA will receive 
intensive training from the PI, Dr. Yank, and the Project Coordinator on procedures for reporting 

adverse events, how to recognize symptoms of clinical depression or anxiety, and the need to call 
the PI when she feels that a participant requires additional services from a mental health or 
health care professional. 
All participant data will be coded in a confidential manner that will protect the identity of the 
participant. Participants will be assigned a unique identifier, and all data entered into the study 
database will only utilize this identifier. A list of the participant names and the associated codes 
will be stored on an encrypted server. Only key study personnel will have access.
The workshop intervention is designed to be appropriate for caregivers of patients with dementia 
living in rural areas. Participants may respond to workshop modules by experiencing and/or 
disclosing their experiences of stress and difficult emotions or situations. The workshops are 
facilitated by peer facilitators who receive rigorous training on the management and triage of 
participants experiencing difficult emotions, which includes when and how to activate built-in 
harm protocols—such as contact of the overseeing health professional if a participant indicates 
they are at any risk for self-harm or harm of others, which in the case of the current study will be 
study PI Dr. Yank. Facilitators keep track of all participants by electronically checking in with them 
at least once weekly during the 6-week workshop. They also observe all online interactions and 
postings daily throughout the workshop. The activities of the facilitators are themselves reviewed 
by “Master Trainers” who monitor the fidelity, quality, and safety of workshop delivery. The 
Master Trainer also has the option (and in the case of a harm protocol activation a requirement) 
of consulting the "Super Trainer" who oversees and trouble-shoots all major workshop deviations 
or concerns. Workshop participants also receive training on how to contact their workshop 
facilitators and how to access self-help materials in the workshop and also have available to them 
a "crisis tab" that contains phone numbers, weblinks and other information for relevant crisis 
hotlines and related resources.
The 
 safety protocol is attached to the IRB application and includes the 
Building Better Caregivers
following characteristics:
Instructions to facilitator to activate the harm protocol in any situation when the facilitator 
"perceives there is a possible imminent threat to a participant's or other third party's well 
being based upon a participant contribution(s) on the Program website"
Protocolized communication by the facilitator to the participant through the secure internal 
email exchange within the workshop ("Post Office")
The letter language is pre-populated and instructs the participant on what to do (e.
g., call 911, contact their doctor) and that a member of the research team will 
reach out to them. That person will be the study physician and PI, Dr. Yank.
Generation of that letter automatically activates the harm protocol and the other 
harm protocol actions below
The workshop platform generates automatic emails to the workshop co-facilitator, Mentor, 
Super Mentor, and study PI and physician Dr. Yank
Once the study physicians receives a harm protocol activation notification, she will telephone the 
participant or relevant local professionals to assess the situation and determine teh required next 
steps. If the situation meets the standards of requiring mandatory reporting (e.g., of concern for 
imminent harm to participant or others), the study physician will perform those activities.
The equivalent harm protocol has been used successfully in the existing provision of a version of 
the workshop to over 3,000 caregivers of veterans by the Veterans Affairs Health Care System 
(see Preliminary Studies section of the Research Strategy for details on the workshop for veteran 
caregivers), with activations of the safety protocol being extremely rare (e.g., average of 3 times 
in 24 months) with successful resolution with participant safety being assured in all cases. The 
protocol has never been activated for elder abuse but has been activated in rare instances for the 
following circumstances:
Concern about the safety/welfare of the workshop participant (caregiver) in a situation 
where 
potential harm might be imposed on him/her by the care partner (e.g., loved one 
with dementia for whom they are caring)
the participant (caregiver) suggested that he/she might be severely depressed 
and in danger of self-harm/suicide
Concern about the care partner (not the study participant) hurting himself/herself—in 
other words, not that they are going to harm the caregiver but that they might harm 
themself
In the case of the VA workship, when the harm protocol is activated, the systems sends a VA 
social worker the activation alers and the social worker has performed the function that the study 
physician will perform in the current workshop being studied. Of note, mandatory reporting of 
elder abuse is required in all states involved in the study. The PI Dr. Yank, who is a general 
internal medicine physician will act as the study physician and mandatory reported. She has 

experiences serving as study physician on multiple studies in the past. If she is on vacation or 
otherwise unavailable to serve as study physician, the study physician responsibilities will be met 
by the back-up study physician, Dr. Karliner, who also is a physician investigator and colleague of 
Dr. Yank in the UCSF Division of General Internal Medicine and the UCSF Mt. Zion General 
Internal Medicine Clinic. 
In all cases when the PI is alerted to a potential safety issue, whether by the Building Better 
Caregivers workshop harm protocol or research team members, The PI will proceed to address 
these as potential adverse events. If the event is determined to be an AE that is moderate or 
higher in degree, Dr. Yank will then contact the participant directly to assess the situation, make 
appropriate referrals, make appropriate contact with local health or other authorities in the 
participant's home state and region, and follow-up with the participant. The participant will have 
given previous consent for the PI to contact him/her directly when such an assessment is 
indicated in the opinion of the RA or Project Coordinator or by activation of the BBC workshop 
harm protocol. Furthermore, study participants will have the full contact information for the study 
team, including email and telephone contact details, so that problems will be identified in a timely 
manner, and should be alleviated by the support and coping skills before the problem becomes 
more serious or chronic.  Finally, at the time of enrollment in the study, the study team will 
provide participants with a list of health resources available to them, which will include mental 
health services and hotline numbers.
12.5  
BENEFITS: 
* 
(REQUIRED) Note: These are the benefits that the IRB will consider during their review. 
They are not necessarily appropriate to include in the consent form.
Possible immediate and/or direct benefits to participants and society at 
large (check all that apply):
Positive health outcome (e.g. improvement of condition, relief of pain, increased mobility, 
etc.)
Closer follow-up than standard care may lead to improved outcomes or patient engagement
Health and lifestyle changes may occur as a result of participation
Knowledge may be gained about their health and health conditions
Feeling of contribution to knowledge in the health or social sciences field
The research presents a reasonable opportunity to further the understanding, prevention, or 
alleviation of a serious problem affecting the health or welfare of children
Other benefit (describe below)
None
12.6  
Explain why the risks to subjects are reasonable in relation to anticipated 
RISK TO BENEFIT RATIO: 
benefits, if any, to the participant or society:
The potential risks are outweighed by the anticipated benefits of reduced depression and reduced 
stress among caregivers of patients with dementia. Caregivers will receive caregiver self-
management and information on dementia caregiving skills, thus potentially can receive direct 
benefit from the study in terms of greater access to caregiving information and methods for 
relieving distress. The burden of participating in 4 surveys and a 6-week program is outweighed 
by the potential benefits associated with developing evidence-based online support for isolated 
dementia caregivers in rural areas with an intervention that is scalable, even in low-resourced 
settings. If the workshop can achieve its goals with rural dementia caregivers, some of those 
most isolated, it would also be expected to be scalable in other low-resourced settings (e.g., in 
urban or suburban environments).
12.7  
Do you have a Data and Safety Monitoring Plan (DSMP) for this 
DATA AND SAFETY MONITORING: 
* 
study (
): (Click the Help link for guidance 
A DSMP is 
 for Greater than Minimal Risk research
required
 
on risk determination) (REQUIRED)
 Yes  
 No

This is not required for minimal risk research but the UCSF IRB strongly recommends 
one to ensure the data collected are adequate to meet the research aims:
13.0
 
Data and Safety Monitoring Plan
13.2  
DATA AND SAFETY MONITORING PLAN: 
* 
(REQUIRED)
All greater than minimal risk studies are required to provide a plan. 
Lack of an adequate plan is one of the most common reasons why 
IRB approval is delayed.
 
Instructions:
Describe the plan for monitoring data quality and participant safety. Key 
areas that should be included in the plan are:
An explanation of the plan to monitor data collection, study progress, 
and safety
A description of who will perform the monitoring and at what 
frequency (e.g., the PI only, a contract research organization, a Data 
and Safety Monitoring Board or Data Monitoring Committee, etc.)
The type of data and events that will be reviewed (e.g., adverse 
events, breaches of confidentiality, unanticipated problems involving 
risk to participants or others, unblinded efficacy data, etc.)
Procedures and timeline for communicating monitoring results to the 
UCSF IRB, the study sponsor, and other appropriate entities
Assurance that the research team will adhere to the UCSF IRB 
reporting requirements
As appropriate:
A plan for conducting and reporting interim analysis
Clearly defined stopping rules
Clearly defined rules for withdrawing participants from study 
interventions
DATA AND SAFETY MONITORING PLAN
 
Procedures for implementing a Data Safety and Monitoring Plan (DSMP) at the University of 
California San Francisco have been developed on a campus-wide basis in conjunction with the 
Institutional Review Board (called the Committee on Human Research at UCSF), the Office of the 
Vice-Chancellor for Research, and the Office of Clinical Research in the School of Medicine.  The 
Data and Safety Monitoring Plan for the proposed project incorporates the policies on human 
subject data and safety monitoring specified by the UCSF Committee on Human Research (i.e. 
UCSF IRB).
 
1.         Risk Assessment – Minimal Risk
This study represents a minimal risk non-therapeutic behavioral intervention.  It encompasses a 
randomized controlled trial among 640 participants with the intervention tested being an online 
workshop (
) that focuses on improving participants’ self-care practices 
Building Better Caregivers
and skills for dementia caregiving. Data collection is performed through use of online surveys and 
phone-based interviews. The Research Assistant (RA) will be trained by Dr. Yank, the PI, who is a 

0.  
1.  
2.  
3.  
4.  
5.  
self-management expert and practicing primary care physician, with expertise in chronic disease 
management and caregiver and self-management research.  In the course of the study, we will 
have several safeguards in place to quickly identify and respond to participants who we feel might 
require professional mental health assessment and services or other forms of medical assessment 
or care. To decrease the likelihood of an adverse event during the study, the RA will receive 
intensive training from the PI, Dr. Yank, and the Project Coordinator on procedures for reporting 
adverse events, how to recognize symptoms of clinical depression or anxiety, and the need to call 
the PI when she feels that a participant requires additional services from a mental health or 
health care professional. 
 
For participants who are randomized to receive the 
 workshop initially 
Building Better Caregivers
or who choose to attend it later after they have finished participation in the control group, during 
the workshop they will receive training on healthy self-care practices and perform self-efficacy 
building activities, including those that may improve their mental and physical well-being.  For 
example, the workshop contains modules on managing stress and difficult emotions including 
symptoms of anxiety, depression, anger, and fatigue. Participants may respond to these modules 
by experiencing and/or disclosing their experiences of stress and difficult emotions. In light of 
this, the 
 workshop itself is staffed by peer facilitators who receive 
Building Better Caregivers
rigorous training on the management and triage of participants experiencing difficult emotions, 
which includes when and how to activate built-in safety protocols—such as contact of the 
overseeing health professional if a participant indicates they are at any risk for self-harm. 
Facilitators keep track of all participants by electronically checking in with them at least once 
weekly during the 6-week workshop. They also observe all online interactions and postings daily 
throughout the workshop. The activities of the facilitators are themselves reviewed by “Master 
Trainers” who monitor the fidelity, quality, and safety of workshop delivery. Workshop 
participants also receive training on how to contact their workshop facilitators. The workshop 
safety protocols already in place have been used successfully in the existing provision of a version 
of the workshop to over 3,000 caregivers of veterans by the Veterans Affairs Health Care System 
(see Preliminary Studies section of the Research Strategy for details on the workshop for veteran 
caregivers), with activations of the safety protocol being extremely rare (3 times in 24 months) 
with successful resolution with participant safety being assured in all cases. The Building Better 
 workshop safety protocol for the purpose of this study will include the addition of the 
Caregivers
study PI being informed of all safety protocol activations.
 
In all cases when the PI is alerted to a potential safety issue, whether by the study RA, Project 
Coordinator, or the 
 workshop safety protocol, The PI will proceed to 
Building Better Caregivers
address these as potential adverse events. Adverse events will be graded according to their 
significance for severe consequences, such as injury or death. If the event is determined to be an 
AE that is moderate or higher in degree, Dr. Yank will then contact the participant directly to 
assess the situation, make appropriate referrals, and follow-up with the participant and RA. The 
participant will have given previous consent for the PI to contact him/her directly when such an 
assessment is indicated in the opinion of the RA or Project Coordinator of by activation of the BBC 
workshop safety protocol. Furthermore, study participants will have the full contact information 
for the study team, including email and telephone contact details, so that problems will be 
identified in a timely manner, and should be alleviated by the support and coping skills before the 
problem becomes more serious or chronic.  Finally, at the time of enrollment in the study, the 
study team will provide participants with a list of health resources available to them, which will 
include mental health services and hotline numbers.
 
2.         Description of Adverse Event Grading and Anticipated Adverse Events
An adverse event (AE) is here defined as any unfavorable and unintended sign, symptom, injury 
or disease temporarily associated with an intervention or procedure, regardless of whether it is 
considered related to an intervention or procedure that occurs during the course of the study. AEs 
will be scored as follows:
 
= No adverse event or within normal limits
= Mild AE – not requiring treatment/follow-up
= Moderate AE – resolved with follow-up
= Severe AE – resulted in inability to carry on normal activities, requiring hospitalization
= Life-threatening or disabling AE – results in an immediate risk of death and/or results in 
persistent or significant disability
= Fatal AE

1.  
2.  
3.  
4.  
 
Adverse events categorized as severe, life-threating/disabling, or fatal are by definition serious 
adverse events. Examples of the types of adverse events we might encounter in the proposed 
study are as follows:
 
Mild AE (ones that do not require treatment/follow-up): reports of depressive symptoms, 
anxiety, and stress that do not interfere with normal activities; fatigue from answering 
study questions (via online survey—and for a sub-set, phone-based interviews); 
frustration when learning to use the online workshop site; anxiety about the ability to 
complete activities for the workshop; and worry about loss of confidentiality/privacy.
Moderate AE (ones that resolve with treatment/follow-up): experiences of transient 
episodes of depressive symptoms or anxiety attacks that modestly affect daily activities 
and resolve with lifestyle, stress management, or usual care approaches.
Severe AE (ones that result in inability to carry on normal activities, those requiring 
hospitalization): patient is so anxious or depressed that they enter a hospital or day-
treatment facility.
Life-threating or disabling AD (ones involving immediate risk of death or persistent 
disability): participant threatening or attempting self-harm or harm to others. These 
events are extremely rare and occur more often in participants with a history of 
depression.
 
Given that the proposed intervention is behavioral and educational in nature, we anticipate that 
mild AEs will comprise the overwhelming majority of reported AEs.  The PI, in consultation with 
the research team, is responsible for evaluating each AE and for and for notifying the project’s 
Data and Safety Monitoring Board and the UCSF Committee on Human Research of the 
occurrence of adverse events.
 
3.         Description of Monitoring Study Progress and Safety of Human Subject 
Participants
The Principal Investigator (PI), Veronica Yank, has primary responsibility for the overall conduct 
of the study and for the safety of research participants.  The PI will ensure that (1) the informed 
consent process is conducted appropriately and that informed consent is obtained prior to 
proceeding with any study procedures; (2) only eligible subjects, per protocol eligibility criteria, 
are enrolled in the study; (3) data are collected and analyzed per protocol requirements; (4) 
procedures are implemented to ensure that the project is consistently monitored for possible 
adverse events; (5) adverse events are reviewed promptly and reported as required to the UCSF 
Committee on Human Research (CHR) (i.e., UCSF IRB); and (6) the privacy and confidentiality of 
study subjects is maintained.  While implementation of aspects of the DSMP may be delegated to 
members of the research team, the PI maintains ultimate responsibility for the project and for the 
safety of study participants. 
 
The Research Team of PI, Co-Is/Consultants (Drs. Kate Lorig, Ken Covinksy, Catherine Chesla, 
Leah Karliner, Jing Cheng, Dolores Gallagher Thompson, and Nancy Fahrenwald), Project 
Coordinator, Data Analyst, and RA will meet quarterly by teleconference to review the progress of 
the study and address any human subject issues that occur. These discussions may involve 
adverse event prevention measures, subject accrual issues, research staff training on protection 
of human subjects, as well as occurrence of adverse events.
 
The Data Safety Monitoring Plan provides for an external, objective Data and Safety Monitoring 
Board (DSMB). The DSMB will meet on a scheduled basis as outlined in the DSMB Charter below. 
The DSMB will review on a scheduled basis reports prepared by the PI, statistician, and data 
management staff on the progress of the project including data on enrollments, comparison of 
target to actual enrollment, overall status of the study participants, information on race/ethnicity, 
gender, adverse events, serious adverse events and other information listed in the DSMB Charter 
below. The DSMB will also determine whether additional effort is required to foster the progress 
of the study, whether adverse events were scored and dealt with appropriately (i.e., was the 
safety and health of the subject addressed, did the subject receive medical attention or medical 

referral as needed, etc.) and whether adverse events were correctly and immediately reported to 
the UCSF Committee on Human Research. The DSMB will determine whether the study should 
continue, be terminated, or be modified based on observed beneficial or adverse effects.
 
4.         Plans for Assuring Compliance with Requirements Regarding the Reporting of 
Adverse Events
The PI is responsible for reporting adverse events to the research team, to the DSMB, and to the 
CHR.  Mild and moderate adverse events will be reported within 10 working days of the 
occurrence or knowledge of the occurrence.  Severe, life-threatening or fatal adverse events will 
be reported immediately to the PI, who will notify the CHR within 48 hours.  This means that 
research assistants will be trained to recognize, respond to, and record adverse events when they 
occur or immediately after they occur to insure the safety of the human subjects; and to report 
adverse events to the PI in a timely manner to insure compliance with institutional policies on 
human subject protection. This also means that research assistants engaged in data collection will 
be able to contact the PI as soon as an adverse event occurs. Specifically, the PI will report the 
following information in writing to the DSMB and UCSF CHR: 1) all severe adverse events 
associated with the study procedures, and/or 2) any incidents or problems involving the conduct 
of the study or patient participation, including problems with the recruitment and/or consent 
processes and/or education of participants about managing stress and coping with depression 
symptoms. The PI also will provide a written report of adverse events of moderate or greater 
severity during the course of the study to the CHR on an annual basis.
 
Severe adverse events are very rare in persons engaging in self-management and educational 
activities, although it is possible that a person with previously unidentified depression, anxiety 
disorder, or other mental illness may experience an aggravation during times of stress.  We will 
stop the study based on instructions from the DSMB or CHR, which will be notified immediately if 
a participant in this study experiences a severe adverse event while enrolled in the study.
 
5.         Plans for Performance of Safety Reviews, for Assuring Data Accuracy and 
Security, and Assuring Protocol Compliance
Safety reviews will be performed by the DSMB as described above.  Under the direction of the PI, 
the security of the data will be safe guarded. As part of the data management and analysis plan, 
all of the data files will be kept in a secure, locked file. All computer data will likewise be 
protected. Data will be entered directly into a computer and files will be matched to verify the 
accuracy of the data. Data will be entered into data files by identification number only. 
Participants’ names will be separated from the data and kept in a locked file cabinet. Access to 
the file cabinet will be strictly controlled by the PI and a project director.  The co-investigators will 
have access to this information only in the event of an adverse event.
 
To assure protocol compliance, the UCSF School of Medicine Office of Research will conduct an 
audit of the project on a periodic basis and evaluate compliance with adverse events reporting 
and the data safety and monitoring plan as outlined in the proposal.
 
6.         Steps Emanating from Data Review
The review of data may result in early termination of the study (see stopping guidelines section 
below), in protocol amendment, or in changes to the data collection plan or study forms. Should 
the protocol be amended as a result of data review, the UCSF CHR will be notified and the 
amendment approved prior to study amendment implementation unless the protocol amendment 
must be implemented to protect the immediate safety of the study subjects. In such a case, the 
protocol amendment will be immediately implemented and the UCSF CHR will be notified directly 
after protocol amendment implementation.
 
7.         Stopping Guidelines
The study will terminate if subjects experience a significantly large number of adverse events.
 

8.         Plans for Reporting Temporary or Permanent Suspension of a Funded Clinical 
Trial
The Principal Investigator will be responsible for immediately reporting to the funding agency (i.
e., the Program Officer responsible for the grant), any temporary or permanent suspension of the 
project and the reason for the suspension.
 
 
 
DSMB CHARTER
 
This Data Safety and Monitoring Board (DSMB) will act in an advisory capacity to the NIH to 
monitor participant safety and evaluate the efficacy of the intervention that is described in the 
research plan.
 
After the DSMB is formed, the initial tasks of the DSMB are to:
Review the entire IRB-approved study protocol and the Manual of Procedures, with regard 
to subject safety, recruitment, randomization, intervention, data management, quality 
control and analysis and the informed consent document with regard to applicability and 
readability.
Recommend changes to the protocol to the PI.
Identify the relevant data parameters and the format of the information to be regularly 
reported.
Recommend subject recruitment be initiated after receipt of a satisfactory protocol. If the 
need for modifications to the protocol, the MOP, consent form, or anything else is 
indicated by the DSMB and/or the Program Administrator, the DSMB will postpone its 
recommendation for the initiation of subject recruitment until after the receipt of 
satisfactory revised protocol(s), etc.
 
After completion of these initial tasks, The DSMB will meet on a regular schedule approximately 
two times a year (with additional meetings as needed). Meetings may be convened as conference 
calls as well as in person.  DSMB meetings will be attended by the PI and her designated staff, 
NIA program staff and the DSMB members. During closed sessions of the DSMB meetings only 
DSMB members and the NIA Program Officer may attend. The DSMB may request that a 
designated individual from the study (often the study’s biostatistician) who has been approved to 
have access to unmasked data will also attend the closed session. At these regular meetings, the 
DSMB tasks are to:
Review masked or unmasked data as needed and appropriate during the trial.
These data can be related to efficacy, recruitment, randomization, compliance, retention, 
protocol adherence, trials operating procedures, form completion, intervention effects, 
gender and minority inclusion, and subject safety.
Identify problems relating to safety during the study.
Identify needs for additional data relevant to safety issues, and request these data from 
the study investigators.
Propose appropriate analyses and periodically review developing data on safety and 
endpoints.
Semi-annually (and on other occasions if necessary), consider the rationale for 
continuation of the study, with respect to progress of randomization, retention, protocol 
adherence, data management, safety issues, and outcome data (if relevant) and make a 
recommendation for or against the trial's continuation.
Review and make recommendations on proposed protocol changes, and or new protocols 
proposed during the trial.
Send written reports following each DSMB meeting to the Program Officer and PI. Send 
additional reports on all issues reviewed by the DSMB as needed.
Provide timely advice on issues regarding data discrepancies found by the data auditing 
system or other sources.
Review manuscripts of trial results as requested; the NIA Program Officer may seek DSMB 
review of manuscripts reporting major outcomes prior to submission for publication.

 
Membership
The Data Safety Monitoring Board is expected to consist of 3 voting members, with the 
expectation that 2 members will constitute a quorum. The members will encompass expertise in 
biostatistics, clinical trials, and dementia caregiving, in addition to any other areas of expertise 
requested by the NIA Program Officer or NIA Director. DSMB members will have no direct 
involvement with the study or conflict of interest with the investigators or institutions conducting 
the study. Members will be nominated and will require approval of the NIA Director after review 
of their respective Curriculum Vitae and Conflict of Interest Statements. One of the DSMB 
members will be identified and agree to act as the Chairperson.
 
Meeting Format
The DSMB meetings will consist of an open and a closed session, both closed to the public 
because discussions may address confidential participant data. The study PI and key staff 
members, DSMB members and NIA Project Scientist attend the open sessions. Discussions at 
these sessions focus on the review of the aggregate data, conduct and progress of the study, 
including participant accrual, protocol compliance, and problems encountered. Data by blinded 
treatment group and unblinded data are not presented in the open session. The primary objective 
of the closed sessions is to review data by blinded study group and, if requested by the DSMB, 
unblinded data. The closed sessions are attended by the DSMB members, the NIA Program Officer 
and an unblinded study statistician. The NIA Program Officer attends the closed and open 
sessions as an observer, not as a DSMB member to answer any policy or administrative questions 
the DSMB members may have. If necessary, an executive session may be requested by the DSMB 
and will be attended only by voting DSMB members. The NIA Program Officer is not permitted to 
attend the executive sessions.
 
Reports
Interim Reports to the DSMB: Interim reports will generally prepared by the study statistician 
and analyst in conjunction with the PI and distributed to the DSMB, at least 10 days prior to a 
scheduled meeting. The contents of the report are determined by the DSMB. Additions and other 
modifications to these reports may be directed by the DSMB on a one time or continuing basis. 
Interim data reports will generally consist of two parts. Part 1 (Open Session Report) provides 
information on study aspects such as accrual, baseline characteristics, and other general 
information on study status. Part 2 (Closed Session Report) will contain data on study outcomes 
and safety data. Data files to be used for interim analyses will have undergone established editing 
procedures to the greatest extent possible.
 
Reports from the DSMB: A formal report from the Chairperson and approved by the DSMB will 
be supplied to the NIH within 6 weeks of each meeting. Each report will conclude with a 
recommendation to continue or to terminate the study. This recommendation will be made by 
formal majority vote. A recommendation to terminate the study will be transmitted to the NIH as 
rapidly as possible, by immediate telephone and fax if sufficiently urgent. In the event of a split 
vote in favor of continuation, a minority report will be contained within the regular DSMB report. 
The report will not include unblinded data, discussion of the unblinded data, etc. A separate set of 
notes summarizing the unblinded session will also be created by the DSMB Chairperson and 
maintained by the NIH. Copies of the blinded DSMB report will be sent to the UCSF IRB in the 
study.
 
Access to Interim Data
Access to the accumulating endpoint data will be limited to as small a group as possible. Limiting 
the access to interim data to the DSMB relieves the investigators of the burden of deciding 
whether it is ethical to continue to randomize patients and helps protect the study from bias in 
patient entry and/or evaluation.
 
Confidentiality

All materials, discussions and proceedings of the DSMB are completely confidential. Members and 
other participants in DSMB meetings are expected to maintain confidentiality.
 
 
 
13.3  
Will a Data and Safety Monitoring Board (DSMB) 
DATA AND SAFETY MONITORING BOARD (DSMB): 
* 
be established: (REQUIRED)
Yes 
No 
13.4  
Provide details from the DSMB's charter, including meeting frequency, and 
DSMB DETAILS: 
affiliations and qualifications of members:   If the DSMB has not yet been established, submit these 
details to us as they become available.
As noted in section 13.2 above, DSMB memebers "will require approval of the NIA Director after 
review of their respective Curriculum Vitae and Conflict of Interest Statements." After our team 
receives the NIA Director's approval of DSMB members, we will submit a modification request to 
add their names to the IRB study information. 
14.0
 Confidentiality, Privacy, and Data Security
14.1  
Indicate how subject privacy will be protected:
PROTECTING PRIVACY: 
Conduct conversations about the research in a private room
Ask the subject how they wish to be communicated with – what phone numbers can be 
called, can messages be left, can they receive mail about the study at home, etc.
Take special measures to ensure that data collected about sensitive issues do not get added 
to their medical records or shared with others without the subject’s permission
Other methods (describe below)
14.2  
Do any of the instruments ask about illegal or stigmatized behavior:
SENSITIVE DATA: 
  Yes  
  No
14.3  
Could a breach of privacy or 
CONSEQUENCES OF A LOSS OF PRIVACY OR CONFIDENTIALITY: 
confidentiality  result in any significant consequences to participants, such as criminal or civil 
liability, loss of state or federal benefits, or be damaging to the participant's financial standing, 
employability, or reputation:
  Yes  
  No
14.4  
Explain any extra steps that will be taken to assure 
EXTRA CONFIDENTIALITY MEASURES: 
confidentiality and protect identifiable information from improper use and disclosure, if any:
All research data will be coded and entered into a database (REDCap) that will be password-
protected and secured behind electronic firewalls on a secure server.  Data from the baseline, 1.5-
, 6- and 12-month interviews will use the unique identifier number and will be stored on a HIPAA 
compliant, secure server using the Research Electronic Data Capture Tool application (REDCap), a 
data storage platform approved and recommended by the UCSF CHR.  Once debriefing interviews 

are transcribed (any identifying information will be removed from transcripts), the digital audio 
files will be destroyed.
Any electronic or hard copy of patients’ contact information will be destroyed once data collection 
and cleaning of the data files is completed. The electronic file of names, addresses and phone 
numbers of potential participants will never be linked directly to data (survey responses). To 
protect against a loss of privacy, all participants will be assigned a unique identifier number, 
which will be used on all data collection forms. No names will be used on the data collection 
forms. A single master list linking participant id numbers and their contact information will be 
kept in a password protected electronic file, on a password protected computer, in the locked 
office of the Project Coordinator of the study. Only the Project Coordinator will have access to the 
master list linking participant study ID numbers and their names and contact information. This list 
will be destroyed once the study is complete.  No participant names will be used in publications or 
presentations that result from the study.
14.5  
Do you anticipate that this study may collect information that State or Federal 
 REPORTABILITY: 
*
law requires to be reported to other officials, such as elder abuse, child abuse, or threat to self or 
others: (REQUIRED)
  Yes  
  No
14.6  
Will this study obain a Certificate of Confidentiality:
CERTIFICATE OF CONFIDENTIALITY: 
  Yes  
  No
14.7  
Will there be any sharing of 
 research test results 
SHARING OF RESEARCH RESULTS: 
EXPERIMENTAL
with subjects or their care providers:
  Yes  
  No
14.8  
Will any personal identifiers be collected: 
IDENTIFIERS: 
* 
(REQUIRED) 
 Yes  
 No
Check all the identifiers that may be included:
Names
Dates
Postal addresses
Phone numbers
Fax numbers
Email addresses
Social Security Numbers*
Medical record numbers
Health plan numbers
Account numbers
License or certificate numbers
Vehicle ID numbers
Device identifiers or serial numbers
Web URLs
IP address numbers
Biometric identifiers
Facial photos or other identifiable images
Any other unique identifier

Could study records include 
 photos or images (even 'unidentifiable' 
* 
ANY
ones): (REQUIRED)
  Yes  
  No
14.9  
 
Will identifiable information be shared with outside groups:
DATA DISCLOSURE: 
  Yes  
  No
14.11  
(check all that apply): 
* DATA COLLECTION AND STORAGE: 
(REQUIRED)
Collection methods:
Paper-based (surveys, logs, diaries, etc.)
Electronic case report forms (CRFs), such as OnCore or another clinical trial management 
portal
Web-based online surveys or computer-assisted interview tool
Mobile applications (mobile or tablet-based)
Wearable devices
Audio/video recordings
Other:
What online survey tool will you use: 
* 
(REQUIRED)
Qualtrics (Recommended)
RedCAP (Recommended)
Survey Monkey (NOT recommended and may require UCSF ITS Security review)
Other
Data will be collected/stored in systems owned by (check all that apply): 
* 
(REQUIRED)
UCSF
SF VAMC
Amazon (Amazon Cloud)
Other academic institution
3rd party vendor (business entity)
Other (explain below)
14.12  
Indicate how data are kept secure and protected from improper use and 
DATA SECURITY: 
disclosure (check all that apply):   NOTE: Whenever possible, do not store subject identifiers on 
laptops, PDAs, or other portable devices. If you collect subject identifiers on portable devices, 
you MUST encrypt the devices.
Data are stored securely in My Research
Data are coded; data key is destroyed at end of study
Data are coded; data key is kept separately and securely
Data are kept in a locked file cabinet
Data are kept in a locked office or suite
Electronic data are protected with a password
Data are stored on a secure network
Data are collected/stored using REDCap or REDCap Survey
Data are securely stored in OnCore
14.13  

  
Confirm below that you will keep data confidential: 
* DATA SECURITY: 
(REQUIRED)  I will keep 
any data sets that include identifiers secure and protected from improper use and disclosure by 
using methods such as:
Physical Security – Keeping data in locked file cabinets, locked offices, locked suites, and 
physically securing computers and servers.
Electronic Security – Following UCSF minimum security standards for electronic information 
, which includes (but is not limited to): not storing identifiers on portable devices 
resources
like laptops or flash drives if they are unencrypted, encrypting portable devices, and storing 
data in password-protected files and on secure networks.
 
Yes 
14.15  
Study data will be:
HIPAA APPLICABILITY: 
 
Derived from the Integrated Data Repository (IDR) or The Health Record Data Service 
(THREDS) at SFGH
Derived from a medical record (e.g. APeX, OnCore, etc. Identify source below)
Added to the hospital or clinical medical record
Created or collected as part of health care
Obtained from the subject, including interviews, questionnaires
Obtained ONLY from a foreign country or countries
Obtained ONLY from records open to the public
Obtained from existing research records
None of the above
15.0
 Financial Considerations
15.1  
Will subjects be paid for participation, reimbursed for time or expenses, or receive any 
* PAYMENT: 
other kind of compensation: (REQUIRED)
 Yes  
 No
15.2  
Subjects payment or compensation method (check all that apply):
PAYMENT METHODS: 
Payments will be (check all that apply):
Cash
Check
Gift card
Debit card
UCSF Research Subject Payment Card
Reimbursement for parking and other expenses
Other:
15.3  
Describe the schedule and amounts of payments, including the total subjects 
PAYMENT SCHEDULE: 
can receive for completing the study: 
If there are multiple visits over time, explain how payments will be prorated for partial 
completion
If deviating from recommendations in Subject Payment Guidelines, include specific 
justification below

Participants will receive $20 cash for the baseline assessment
Participants will receive $20 cash  for the 1.5 month assessment
Participants will receive $20 cash for the 6th month assessment
Participants will receive $20 cash for the 12th month assessment
Total payment ($80)
 
Debriefing interview. Participants will receive $30 cash for the one time 30 minute telephone 
interview.
15.4  
Will subjects or their insurance be charged for any study activities:
COSTS TO SUBJECTS: 
  Yes  
  No
16.0
 Qualifications of Key Study Personnel
16.1          
 
  NOTE: This information is required and your application will be 
considered incomplete without it. If this study involves invasive or risky 
procedures, or procedures requiring special training or certification, please 
identify who will be conducting these procedures and provide details 
about their qualifications and training. Also identify each person who will be 
involved in the consent process. Click the orange question mark for more 
    
   
information and examples.
Under qualifications, please include:
Academic Title
Institutional Affiliation (UCSF, SFGH, VAMC, etc.)
Department
Certifications
        
  
  
 
November, 2015 - NEW Definition of Key Study Personnel and 
    
CITI Training Requirements:
  
  
include the Principal Investigator, other 
UCSF Key Study Personnel 
investigators and research personnel who are directly involved in conducting 
research with study participants or who are directly involved in using study 
participants’ identifiable private information during the course of the research. 
Key Personnel also include faculty mentors/advisors who provide direct 
oversight to Postdoctoral Fellows, Residents and Clinical Fellows serving as PI 
        
on the IRB application.
 
The IRB requires that all Key Study Personnel 
complete Human Subjects Protection Training through 
 
CITI prior to approval of 
a new study, or a modification in which KSP are being added. More information 
  
  
on the CITI training requirement can be found on our website.  
      
KSP Name
Description of Study 
Responsibilities - Briefly 
describe what will each 
person be doing on the study. 
If there are procedures 
requiring special expertise or 
certification, identify who will 
be carrying these out. Also 
identify who will be obtaining 
informed consent.
Qualifications, Licensure, and 
Training
Dr. Yank is and Early 
Stage Investigator and 

Dr. Yank, Veronica MD
Principal Investigator. Dr. 
Yank will be responsible 
for all aspects of the 
proposed project.
Assistant Professor, 
Division of General 
Internal Medicine, UCSF, 
and Affiliated 
Investigator, Veterans 
Affairs Center for 
Innovation to 
Implementation, Palo 
Alto VA Health Care 
System. Dr. Yank brings 
to the work high caliber 
academic training, a 
productive research track 
record, experience with 
both clinical trials and 
implementation sciences 
research, leadership 
skills in team 
management, and an in-
depth understanding of 
behavioral and self-
management 
interventions in general 
and the Building Better 
Caregiver online 
workshop intervention in 
particular. Dr. Yank has 
worked very closely with 
proposal Co-I Dr. Lorig 
on prior research 
projects. In addition, 
upon her recent transfer 
from Stanford to UCSF, 
she has quickly built an 
excellent team containing 
all the necessary 
additional expertise for 
the work—including Drs. 
Covinksy, Chesla, 
Karliner, and Cheng at 
UCSF, Dr. Gallagher 
Thompson at Stanford, 
and Dr. Fahrenwald at 
South Dakota State 
University. In addition to 
their research expertise, 
these Co-Investigators 
and Consultants have 
impressive credentials for 
supporting junior 
investigators and are 
committed to assisting 
Dr. Yank in all aspects of 
her role as PI.
Dr. Cheng, Jing MD,MS,
PhD
Senior Statistician. She 
will contribute expertise 
in the statistical methods 
of randomized controlled 
trials, including those 
addressing chronic 
conditions; and statistical 
expertise in studies of 
caregivers and families, 
behavior change and self-
management 
interventions, and 
aspects of health 
Dr. Cheng is Professor, 
Center to Address 
Disparities in Oral Health 
(CAN DO) and School of 
Dentistry, UCSF, and the 
UCSF Clinical and 
Translational Science 
Institute (CTSI).

communication and 
literacy.
Chesla, Catherine, RN, 
PhD, FAAN
Co-Investigator. She will 
contribute, in particular 
to Aim 2, her expertise 
on family intervention 
research, which 
contextualizes 
interventions within the 
broader framework of 
individuals, families, and 
communities; qualitative 
methodologies, including 
approaches to the 
collection and analysis of 
interview data; and 
community based and 
translational research.
Dr. Chesla is Professor 
and Interim Chair, 
Department of Family 
Health Care Nursing, 
School of Nursing, UCSF.
Dr. Covinsky, Kenneth E 
MD, MD
Co-Investigator. He will 
contribute, in particular 
to Aim 1, his expertise on 
risk factors and outcome 
measures among older 
adults, dementia 
caregivers, and persons 
living with Alzheimer’s 
disease or other 
dementias—including 
their determinants of 
health, functional status, 
healthcare utilization, 
and institutionalization.
Dr. Covinsky is Professor 
in the Division of 
Geriatrics, UCSF, and PI 
of the UCSF Older 
Americans Independence 
Center, one of 15 U.S. 
NIA-funded “Pepper 
Centers.” He also holds a 
K24 mid-career award for 
mentoring junior faculty 
whose research is 
pertinent to older adults.
Dr. Karliner, Leah MD, MD
Co-Investigator. She will 
contribute to both Aims 
her expertise on survey-
based research—
including design 
characteristics and 
technology-mediated 
delivery; implementation 
and dissemination health 
science; health 
communications among 
underserved and high-
risk patients and families 
about chronic conditions, 
hospitalization, and 
community support 
needs; and participant 
recruitment in diverse 
and underserved 
communities.
Dr. Karliner is Associate 
Professor, Division of 
General Internal 
Medicine, School of 
Medicine, UCSF.
17.0
 End of Study Application
17.1  End of Study Application Form        
 
  To continue working on the Study 
: Click on the section you need to edit in the left-hand menu. Remember to save 
Application
        
through the entire Study Application after making changes.
 
If you are done working on 

        
:
the Study Application
 
Before proceeding, please go back to Section 
Important: 
4.0 Initial Screening Questions and Save and Continue through the form to make sure all the 
relevant sections and questions have been included. If you've changed any answers since 
you started, the branching may have changed. Your application will be incomplete and it will 
        
have to be returned for corrections. 
 
Once you are sure the form is complete, click 
Save and Continue. If this is a new study, you will automatically enter the Initial Review 
Submission Packet form, where you can attach consent forms or other study documents. 
        
Review the 
 for a list of required attachments.
Initial Review Submission Checklist
 
  
       
Answer all questions and attach all required documents to speed up your approval.
 
       
  
              
 
 
 
 
 
The UCSF IRB wants your feedback about this new form. Please click 
the link to take a 
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brief survey