Developing a Pain Identification and Communication Toolkit for Family Caregivers of Persons With Dementia
Phase: NA
Conditions: Dementia, Chronic Pain
Sponsor: Weill Medical College of Cornell University

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Developing a Pain Identification and Communication Toolkit 
(PICT) for Family Caregivers of Persons with Dementia 
 
 
 
 
 
 
 
NCT# NCT03853291 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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TITLE: Developing a Pain Identification and Communication Toolkit (PICT) for Family Caregivers of Persons 
with Dementia 
 
IRB Protocol #: 1811019718 
Version Date: September 17, 2021 
Funding Source(s): National Institute on Aging 
 
Principal Investigator: 
Catherine Riffin, PhD 
420 East 70th St. 3rd Floor, Suite B 
(646) 962-7160 
(646) 962-0812 
acr2213@med.cornell.edu 
Co-Investigators: 
 
 
M. Carrington Reid 
525 E. 68th St., 14th Floor Box 39 
(212) 746-1378 
(212) 746-4888 
mcr2004@med.cornell.edu 
Patricia Kim 
525 E. 68th St., 14th Floor Box 39 
(212) 746-1758 
(212) 746-4888 
pak2020@med.cornell.edu 
Lilla Brody 
525 E. 68th St., 14th Floor Box 39 
(212) 746-7317 
(212) 746-4888 
lab4012@med.cornell.edu 
Sama Joshi 
525 E. 68th St., 14th Floor Box 39 
(212) 746-7317 
(212) 746-4888 
saj4010@med.cornell.edu 
Priya Mukhi 
525 E. 68th St., 14th Floor Box 39 
(212) 746-7317 
(212) 746-4888 
prm4007@med.cornell.edu 
Taeyoung Park 
525 E. 68th St., 14th Floor Box 39 
(212) 746-7317 
(212) 746-4888 
tap4003@med.cornell.edu 
 
 
External Collaborators: 
Chuck Henderson 
Cornell University 
crh2@cornell.edu 
607-255-4488 
Elissa Kozlov 
Rutgers University 
ekk49@sph.rutgers.edu 
914-715-3012 
Karl Pillemer 
Cornell University 
kap6@cornell.edu 
607-255-8086 
Keela Herr 
University of Iowa 
keela-herr@uiowa.edu 
319-335-7080 
 
All external collaborators will be consulting on study design and working with completely de-identified data. 

Protocol # 1811019718 
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1.1 Study Objectives 
1.1.1 Objectives 
Objective 1: To develop and refine PICT, an intervention to train family caregivers of PWD how 
to administer an observational pain assessment tool and communicate the results to health care 
providers. 
 
Objective 2: To evaluate the feasibility and acceptability of the finalized version of PICT among 
family caregivers of PWD and health care providers 
 
Objective 3: To test the preliminary efficacy of PICT on 1) caregiver ability to identify pain 
symptoms; and 2) caregiver efficacy in communicating with health care providers 
 
 
1.1.2 Hypotheses / Research Questions 
Hypothesis 1: As this study objective involves intervention development only, no hypotheses are 
given. 
 
Hypothesis 2a (feasibility): 70% or more of participants will meet the benchmark for feasibility, 
defined by participant retention and adherence to the intervention. 
 
Hypothesis 2b (acceptability): 70% or more of participants will meet the benchmark for 
acceptability, defined by participant ratings on questionnaires related to “helpfulness,” “future 
use,” and “overall comprehension” of the intervention content. 
 
Hypothesis 3: PICT will be more effective than an attention control for improving caregivers’ 
ability to identify pain in PWD and to initiate pain related-communication with health care 
providers. 
 
 
2. Background and Significance 
Dementia afflicts more than 5 million older adults (ages 65 and older) in the United States,1 the majority 
of whom reside in the community.2 Up to 60% of affected individuals suffer from pain,3,4 with similar 
prevalence estimates across dementia subtypes (e.g., Alzheimer’s disease, vascular dementia).5 
Although best practice guidelines have emphasized the importance of routine pain assessment of older 
persons with dementia (PWD),6 pain remains severely under-detected and undermanaged in this 
population.7,8 Untreated pain has profound effects on individuals’ quality of life,9,10 and is associated 
with numerous adverse outcomes, including physical impairment,11 depression,12,13 social isolation,14,15 
increased health service use,16 and disruptions to family functioning.17,18 One of the greatest barriers to 
detecting and treating pain in PWD is impaired communication.19 As dementia progresses, the capacity 
to communicate effectively about one’s pain diminishes;20 individuals may be unable to understand or 
verbally articulate their discomfort, and instead express their pain through non-verbal behaviors (e.g., 
facial expressions, agitation).21 In such cases, self- reports of pain are not feasible and behavioral 
assessment is recommended.22,23 Family caregivers (spouses; adult children; other close relatives) are 
well situated to detect PWD’s pain symptoms and communicate those symptoms to health care 
providers. Nearly 80% of community-dwelling PWD receive help from a caregiver.24,25 These caregivers 
are in frequent, if not constant, contact with PWD26 and are highly involved in their disease 
management activities.27,28 Unlike health care providers who are likely to see the patient in a single 

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context (the treatment visit), caregivers have the opportunity to observe the PWD in diverse situations 
(e.g., at rest, during transfers, after the administration of pain medication), which is necessary not only 
for identifying the presence of pain, but also for determining under what circumstances it is likely to 
occur. Caregivers have frequent opportunities to communicate their observations to providers as 
companions to PWD at their doctor’s visits.29,30 Indeed, providers commonly turn to family members 
who are familiar with the patient for help interpreting the patient’s pain,31-33 but caregivers are 
sometimes reluctant to bring up pain-related concerns with providers.34,35 While studies indicate that 
caregivers are fair or poor judges of PWD’s pain and disregard non-verbal pain behaviors when unaided 
by pain assessment tools,20,36 recent research shows that laypersons (caregivers and non-caregivers) are 
able to differentiate painful from non-painful experiences effectively when provided standardized tools 
to facilitate behavioral observation.37,38 This research has predominantly been conducted in highly 
controlled experimental settings (observations of video-recorded actors); few studies have investigated 
how observational tools may be used by caregivers actively caring for PWD’s in real-world clinical 
contexts.39,40 Further, while research has documented caregivers’ frustration regarding pain-related 
communication with health care providers,41,42 there exist few interventions to help caregivers of PWD 
to articulate their pain-related concerns to medical professionals. 
 
3. Study Design and Methods 
3.1 Overall Design 
 
This study includes the following phases: 1) intervention manual development; 2) Interviews; 3) 
field-testing; and 4) pilot randomized trial. 
 
Manual development: The Pain Identification and Communication Toolkit (PICT) will be 
documented in a manual for health care providers and a workbook for caregivers. The provider 
manual will provide instruction on using the Pain in Advanced Dementia (PAINAD) assessment tool 
to detect pain in persons with dementia (PWD) and education on specific strategies to promote 
effective communication between family caregivers and providers, with an emphasis on fostering 
culturally competent interactions with PWD and their caregivers. The caregiver workbook will 
include instructions for how to identify pain symptoms using the PAINAD, information on 
differentiating between pain and dementia symptoms, strategies for effective communication with 
health care providers, as well as a Question Prompt List (QPL) to help facilitate action planning and 
culturally appropriate medical visit interactions. A research team comprised of two geriatricians, a 
geriatric nurse, a gerontologist, and developmental psychologist with extensive experience in 
conducting research in area of clinical communication will assemble the initial versions of the 
provider manual and caregiver workbook. 
 
Interviews: As part of the manual development, interviews will be conducted with family caregivers 
(n=25) and health care providers (n=20) in-person in private offices at WCMC/NYP or over the 
telephone. The participant, in special circumstances (e.g. scheduling issues) may opt to have the 
interview take place in a private location convenient to them. All interviews will be recorded and 
transcribed by a certified, secure, and WCM-approved transcription agency. Participants will be 
recruited at WCM/NYP locations including the Center on Aging and Weill Cornell Medical Associates. 
Participants may also be recruited from WCM/NYP geriatric and palliative care support groups. The 
primary objectives of the interviews are to: a) adapt the PAINAD for use with caregivers by asking 
them to comment on its format and content; and b) generate an initial question pool for the 
Question Prompt List (QPL). The secondary objective of elucidating concerns about using a QPL to 

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encourage caregivers to ask questions (e.g., increasing visit time) and ways to address those 
concerns (e.g. instructing caregivers to ask only questions that are of particular concern). The 
interviews will also address formatting considerations of the caregiver workbook and provider 
manual (e.g. font size, language that is easy to understand, space for notes). Caregivers will also be 
asked to fill out a brief questionnaire that will be sent to participants along with the PAINAD tool by 
email or postal mail, or given to the participant prior to their interview. The questionnaire will 
include demographics, caregiving role, and patient health questions. Participants will be provided a 
self-addressed stamped envelope to mail this survey back; or they can use the WCMC secure file 
transfer to email back the questionnaire. 
 
Field testing. Once initial versions of the PICT manual and workbook are developed, they will be 
iteratively field-tested and vetted by family caregivers (n=25 per iteration) and health care providers 
(n=20 per iteration). Participants will be recruited at WCM/NYP locations including the Center on 
Aging and Weill Cornell Medical Associates. After reviewing the PICT workbook, caregivers will 
complete a brief questionnaire about the content, format, and perceived utility of PICT, as well as 
ways to enhance its cultural relevance. They will also complete a brief (15-20 minute) semi- 
structured interview to clarify their perspectives. Health care providers will answer a similar set of 
questions. Results from this first field-test will inform the modified version of PICT and will address 
key issues, such as the feasibility of using research nurses (and other practice staff) to administer the 
intervention, anticipation of participant burden for caregivers, and adequacy of PICT format and 
instructions. Study procedures will be repeated (including IRB approval) with a new sample of 
caregivers (n=25) and providers (n=20). Results from the second field-test will be used to create the 
finalized intervention of PICT. Prior research indicates that a feasible intervention should be 
generated after two iterations. 
 
Pilot testing. Family caregivers will be randomly assigned to PICT (n=50) or a control (usual care) 
condition (n=50). 
 
Participants in both conditions will be asked to complete an identical pre-test questionnaire. The 
questionnaire will be sent to via email or postal mail, and/or will be scheduled to be completed over the 
phone. We will ask about the participant’s background, caregiving role, and comfort speaking with health 
care providers. It will take approximately 15-20 minutes to complete. 
 
Intervention condition. Participants in the intervention condition will be contacted by a member of 
the study team to start the PICT workbook. The PICT workbook consists of four sessions and will be 
completed over the telephone with a study team member. Sessions are conducted once a week and 
last approximately 30-60 minutes each. Participants will also be asked to read sections or the PICT 
workbook and complete exercises between sessions. The reading and exercises will take 10-15 
minutes to complete. After the final session of the intervention, a study team member will contact 
the participant by telephone to complete another set of questionnaires (at 12 weeks after the pre- 
test questionnaire). The questionnaire will be sent to via email, postal mail, or will be scheduled to be 
completed over the phone. The post-test questionnaires will take approximately 20 minutes to 
complete and will ask about the participant’s comfort and confidence in communicating with health 
care providers, behaviors he or she observes in the recipient, and views of the PICT workbook. 
Participants will also be asked to participate in a 20-30 minute telephone interview to elaborate their 
responses to the questionnaire. Participants must agree to be audiotaped to participate in the study. 

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Control condition. Caregivers in the control condition will receive an informational pamphlet about 
pain in dementia and a link to the Alzheimer’s Association website. Twelve weeks after the 
participant completes the pre-test questionnaire, she or he will be contacted by a member of the 
study team to complete the post-test questionnaire. The questionnaires will be sent via email, postal 
mail, or will be scheduled to be completed over the phone and will take approximately 20 minutes to 
complete. 
 
When caregivers express interest in the study through any recruitment method; they will be called 
and will be screened for eligibility which includes questions about care hours, length of care, 
distance, enrolled in hospice, access to internet, and must be cognitively intact (BOMC<=10). Any 
study data collected for potential participants that do not meet eligibility will be immediately 
deleted. Informed Consent and HIPAA authorization for caregivers and informed consent for 
providers will occur in-person at recruitment sites (by paper or REDCap), remotely (by mail, secure 
file transfer, or REDCap), or just prior to in-person interviews as outlined in the Informed Consent 
section. These processes will be the same for all phases of the study. 
 
3.2 Interviews, Focus Groups, Surveys, and/or Observations 
A. 
Administration 
▪ 
Timing and Frequency 
- Interview and field-testing phases: Caregiver and healthcare professional subjects will 
complete a one-time 20-30 minute interview accompanied by a brief questionnaire. 
Interviews will be conducted by a research nurse or trained co-investigators. 
- Pilot testing phase: PICT will consist of 4 weekly 30-60-minute sessions delivered by a 
study team member. In between sessions, participants will have 10-15 minutes of 
reading and exercises to complete. 
▪ 
Location 
Interview and field testing phases will take place in-person in private offices at 
WCMC/NYP or over the telephone. The participant, in special circumstances (e.g. 
scheduling issues) may opt to have the interview take place in a private location 
convenient to them. 
Pilot testing will take place over the telephone. 
▪ 
Procedures For Audio And Visual Recording 
All interviews will be recorded and transcribed by a certified, secure, and WCM- 
approved transcription agency. 
▪ 
Person Identifiers 
Co-investigators may review EPIC to identify potential participants who meet eligibility. 
Contact information and appointment information will also be collected for either in- 
person or letter (postal and email) recruitment. Only data from potential participants 
will be stored on secure servers. These data will be deleted upon completion of the 
study or immediately if a patient chooses not to participate in the study. 

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B. Study Instruments 
Interview Phase 1 
▪ 
Caregiver subjects 
o 
Screening questions 
▪ 
Caregiving questions 
▪ 
Brief cognitive screener (BOMC) 
o 
Brief Questionnaire – Caregiver 
▪ 
Demographics 
▪ 
Caregiving Questions 
▪ 
Patient Health Characteristics 
o 
Interview Guide – Caregiver 
o 
Field test questions - Caregiver 
▪ 
Healthcare Professional subjects 
o 
Brief Questionnaire – Provider 
▪ 
Demographics 
▪ 
Medical practice questions 
o 
Interview Guide – Provider 
o 
Field test question – Provider 
Pilot Test Phase 
▪ 
Caregiver subjects in PICT (intervention) group 
o 
Pre-test Questions for All Caregiver Participants 
o 
Post-test Questions for Caregivers in PICT Group 
o 
Exit Interview Questions 
▪ 
Caregiver subjects in control group 
o 
Pre-test Questions for All Caregiver Participants 
o 
Post-test Questions for Caregivers in Control Group 
 
4. Study Design 
4.1 Study Population 
Healthy volunteers that are caregivers and healthcare providers of persons with dementia and pain. 
 
4.2 Inclusion Criteria 
 
Family Caregivers: 
1. Age 21 or older 
2. English speaking 
3. Cognitively intact (BOMC ≤10) 
4. Provides at least 8 hours of care per week to a person with dementia who also has a pain 
diagnosis 
5. Has access to the internet 
 
Healthcare professionals: 
1. Currently providing clinical services to persons with dementia and/or chronic pain 
2. Has provided these clinical services for at least 1 year 

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4.3 Exclusion Criteria 
 
Family Caregivers: 
1. Paid Caregiver 
2. Age 20 or younger 
3. Non-English speaking 
4. Cognitively impaired 
5. Does not provide at least 8 hours of care per week to a person with dementia who also has a 
pain diagnosis 
6. Has provided care < 6 months 
7. Currently enrolled in hospice 
8. The patient to whom the caregiver provides assistance is enrolled in hospice 
 
Healthcare professionals: 
1. Not currently providing clinical services to persons with dementia and/or chronic pain 
2. Has provided these clinical services for fewer than 1 year 
 
4.4 Strategies for Recruitment and Retention 
Overview of Caregiver Recruitment Procedures 
 
Co-investigators will meet with health care providers who see patients at the Center on Aging, the 
Alzheimer’s Disease and Memory Disorders Program, and Weill Cornell Internal Medical Associates 
to make them aware of the study protocol, including the plan to send recruitment letters (postal 
mail or email) to their patients’ caregivers. During the meetings, the co-investigators will ask each 
provider to review his or her patient list and identify individuals who have both pain and dementia, 
as well as a family caregiver. When meeting with these healthcare providers, co-investigators will 
verify that the caregiver lives with the patient and/or obtain the caregiver contact information from 
the providers. Recruitment letters will then be sent by mail or email (when available) to the 
caregivers of the identified patients. Patients themselves will not be contacted, and every effort will 
be made to contact the caregiver directly. When possible, letters will be sent to the emergency 
contact (i.e., caregiver) if their telephone matches that of the patient, or by email. The recruitment 
letter will describe the study and advise caregivers that they may decline participation by emailing 
or placing a telephone call to the study team. Approximately 2 weeks after the initial letter (postal 
mail or email) is sent, caregivers who have not opted out will be telephoned or emailed by the 
trained co-investigator to confirm their interest. 
 
For caregivers that care for a patient at recruitment sites, patients’ medical records will first be 
reviewed by a trained co-investigator who will confirm whether or not they meet eligibility criteria 
(dementia and pain diagnosis). Recruitment site caregivers will be approached in the waiting room 
prior to their doctor’s visit. The co-investigator will perform the consenting process either in the 
waiting room or a private office, if available. 
 
Other caregivers will be recruited via caregiving resources and groups in the community including 
the WCM/NYP Geriatrics caregiver support groups, local community centers, senior service 
agencies, etc. Interested individuals will provide their name and contact details on a sign-up sheet. 

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Trained co-investigators will use the caregivers’ preferred method of contact to inform them about 
the study (phone or email). The procedure outlined above (i.e., co-investigator mails/emails the 
consent form in advance and requests the signed consent form back prior to conducting the 
interview) will then be followed. If time allows, co-investigators may choose to have participants 
consent in-person at recruitment sites, and in that case, they will also be given the first survey to 
mail back at their convenience after consent is obtained. 
 
Caregivers may also contact the study team to participate after seeing a recruitment flyer. The 
Guthrie Clinic also has agreed to be a recruitment site. They will be limited to posting and handing 
out WCM flyers to potential participants. 
Additional efforts will rely on making study information available on online platforms. Online 
platforms may include, but are not limited to: caregiver/dementia interest pages on Facebook, 
participant registries, online bulletin boards, mobile apps and websites, etc. Methods include, but 
are not limited to: posting flyers, posting messages describing the project and inviting interested 
participants to contact study members (see “Social Media Posting” document), including study 
information in e-newsletters, etc. Permission from group administrators will be received prior to 
posting on any social media group platform. In addition, ResearchMatch.org will be added as a 
recruitment method. 
Additionally, snowball recruitment method will be used to ask potential participants to share study 
information with other caregivers who may be interested in the study. 
 
Trained co-investigators will use the caregivers’ preferred method of contact to inform them about 
the study (phone or email). The procedure outlined above (i.e., co-investigator mails/emails the 
consent form in advance and requests the signed consent form back prior to conducting the 
interview or REDCap consent) will then be followed. 
 
Interview and field testing phases: Caregiver participants will be compensated $15 after completing 
the study interview in the form of a ClinCard. 
 
Pilot testing phase: Participants will be compensated $10 after completing the pre-test 
questionnaires and $30 after completing the post-test questionnaires. Participants in the PICT 
(intervention) condition will also receive $10 after each of the 4 sessions. Compensation will be paid 
in the form of a ClinCard. 
 
Overview of Health Care Provider Recruitment Procedures 
Health care providers will be informed of the opportunity to participate in the brief questionnaire 
and interview during practice site meetings and/or one-on-one conversations about the project. 
 
5. Registration Procedures 
5.1 Subject Registration (WCM only) 
Subjects will be registered within the WRG-CT as per the standard operating procedure for 
Subject Registration. 
 
5.2 Subject Registration (Sub-sites) 
N/A 

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6. Study Procedures 
6.1 Schedule of Assessments 
Table 1. Schedule of trial events for interview and field testing phases 
 
Pre-study 
Visit 1 
(Interview) 
Screening 
X 
Informed Consent 
X 
X 
Demographics and 
Questionnaire 
X 
Semi-structured Interview 
X 
 
Table 2. Schedule of trial events for the pilot test phase 
 
Pre- 
study 
Week 1 
Week 2 
Week 3 
Week 4 
Post- 
study 
Screening 
X 
Informed Consent 
X 
Demographics and 
Pre-test Questions 
X 
Weekly Session * 
X 
X 
X 
X 
In-home reading * 
X 
X 
X 
X 
Post-test Questions 
X 
Exit Interview * 
X 
* denotes intervention participants only 
 
7.0 Data Reporting / Regulatory Considerations 
7.1 Data Collection 
The data collection plan for this study is to utilize REDCap to capture all treatment, toxicity, efficacy, 
and adverse event data for all enrolled subjects. 
 
7.1.1 REDCap 
REDCap (Research Electronic Data Capture) is a free data management software system that is 
fully supported by the Weill-Cornell Medical Center CTSC. It is a tool for the creation of 
customized, secure data management systems that include Web-based data-entry forms, 
reporting tools, and a full array of security features including user and group based privileges, 
authentication using institution LDAP system, with a full audit trail of data manipulation and 
export procedures. REDCap is maintained on CTSC-owned servers that are backed up nightly 
and support encrypted (SSL-based) connections. Nationally, the software is developed, 
enhanced and supported through a multi-institutional consortium led by the Vanderbilt 
University CTSA. 

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7.2 Regulatory Considerations 
 
7.2.1 Institutional Review Board/Ethics Committee Approval 
As required by local regulations, the Investigator will ensure all legal aspects are covered, and 
approval of the appropriate regulatory bodies obtained, before study initiation. 
Before initiation of the study at each study center, the protocol, the ICF, other written material 
given to the patients, and any other relevant study documentation will be submitted to the 
appropriate Ethics Committee. Written approval of the study and all relevant study information 
must be obtained before the study center can be initiated or the IP is released to the Investigator. 
Any necessary extensions or renewals of IEC/IRB approval must be obtained for changes to the 
study, such as amendments to the protocol, the ICF, or other study documentation. The written 
approval of the IEC/IRB together with the approved ICF must be filed in the study files. 
The Investigator will report promptly to the IEC/IRB any new information that may adversely 
affect the safety of the subjects or the conduct of the study. The Investigator will submit written 
summaries of the study status to the IEC/IRB as required. On completion of the study, the IEC/IRB 
will be notified that the study has ended. 
 
Neither the Investigator nor BMS will modify or alter this protocol without the agreement of the 
other. All agreed protocol amendments will be clearly recorded on a protocol amendment form 
and will be signed and dated by the original protocol approving signatories. All protocol 
amendments will be submitted to the relevant institutional IEC/IRB for approval before 
implementation, as required by local regulations. The only exception will be when the 
amendment is necessary to eliminate an immediate hazard to the trial participants. In this case, 
the necessary action will be taken first, with the relevant protocol amendment following shortly 
thereafter. 
Once protocol amendments or consent form modifications are implemented at the lead site, Weill 
Cornell Medicine, updated documents will be provided to participating sites. Weill Cornell 
Medicine must approve all consent form changes prior to local IRB submission. 
Relevant study documentation will be submitted to the regulatory authorities of the participating 
countries, according to local/national requirements, for review and approval before the beginning of 
the study. On completion of the study, the regulatory authorities will be notified that the study has 
ended. 
 
7.2.2 Ethical Conduct of the Study 
The Investigators and all parties involved should conduct this study in adherence to the ethical 
principles based on the Declaration of Helsinki, GCP, ICH guidelines and the applicable national 
and local laws and regulatory requirements. 
 
This study will be conducted under a protocol reviewed and approved by the applicable ethics 
committees and investigations will be undertaken by scientifically and medically qualified 
persons, where the benefits of the study are in proportion to the risks. 

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7.2.3 Informed Consent 
A co-investigator or qualified designee must obtain documented consent according to ICH-GCP and local 
regulations, as applicable, from each potential subject or each subject’s legally authorized 
representative prior to participating in the research study. Subjects who agree to participate will 
receive an oral consent document prior to speaking to a co-investigator. 
 
Informed Consent will occur prior to their pre-test questionnaire, by oral consent for participants until 
virtual consent methods are approved by the WCM IRB. For oral consent, a member of the study 
team will review the ICF in-full (see Oral Consent Script attachment) by phone, allowing for 
questions and reminding the potential subject that participation is voluntary. Oral confirmation 
of consent to participate will be documented by the study team member. 
 
Once virtual consent processes are established with the JCTO, we will submit an amendment with 
the IRB to conform to these new policies. We feel that with our older adult population, at a higher 
risk to COVID-19, that this is best practices in human subjects for participants not to leave their 
home in order to participate in this study. REDCap consent documents were previous approved in 
an earlier amendment and we are prepared to use these methods accompanied by a phone 
discussion as stated above for oral consent. 
 
The initial ICF, any subsequent revised written ICF and any written information provided to the 
subject must approved by IRB prior to use. The ICF will adhere to IRB/IEC requirements, applicable laws 
and regulations. 
 
7.2.4 Compliance with Trial Registration and Results Posting Requirements 
Under the terms of the Food and Drug Administration Modernization Act (FDAMA) and the Food and Drug 
Administration Amendments Act (FDAAA), the Sponsor-Investigator of the trial is solely responsible 
for determining whether the trial and its results are subject to the requirements forsubmission 
to http://www.clinicaltrials.gov. Information posted will allow subjects to identify potentially 
appropriate trials for their disease conditions and pursue participation by calling a central contact 
number for further information on appropriate trial locations and trial site contact information. 
 
7.2.5 Record Retention 
Essential documents are those documents that individually and collectively permit evaluation of the 
study and quality of the data produced. After completion of the study, all documents and data 
relating to the study will be kept in an orderly manner by the Investigator in a secure studyfile. 
Essential documents should be retained for 2 years after the final marketing approval in an ICH 
region or for at least 2 years since the discontinuation of clinical development of the IP. In 
addition, all subject medical records and other source documentation will be kept for the 
maximum time permitted by the hospital, institution, or medical practice. 
 
8. Statistical Considerations 
Interviews: Interview transcripts will be analyzed according to the constant comparative method, in 
which new concepts are compared to existing codes (labels that catalog key concepts), existing codes 
are refined, and a coding structure is developed in stages. This process will continue until theoretical 
saturation is reached - the point at which no new information is generated from additional interviews. 

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Pilot testing: statistical considerations. Feasibility will be examined in terms of rates of recruitment and 
number of sessions completed by participants in the intervention condition. Preliminary analyses to 
compare the intervention vs. control group on PWD and caregiver sociodemographic characteristics will 
be carried out in linear models (for continuous variables) and logistic-linear models (for categorical 
variables). The effectiveness of the intervention will be evaluated in a statistical model that includes 
treatment (control vs. intervention) and time of assessment (baseline vs. 4 weeks post intervention) as 
fixed classification factors; the interaction of treatment and time; covariates such as age and gender; 
and family caregivers (30 per treatment group) as levels of a random classification factor. The primary 
dependent variable (caregiver contacts primary care practice) is dichotomous, and analysis is by a 
logistic-linear mixed model with binomial error. Self-efficacy will be included in the model as a fixed 
classification factor (categorized in 2 levels) as will its interaction with treatment and time. Interactions 
with other key sociodemographic and clinical variables will also be examined. 
 
 
9. Adverse Event Reporting Requirements 
Adverse event (AE) monitoring and reporting is a routine part of clinical research. Safety is monitored by 
evaluation of adverse events reported by subjects or observed by investigators or research staff, as well 
as by other investigations such as clinical laboratory tests, x-rays, electrocardiographs, etc. 
 
9.1 Adverse Event Definition 
An adverse event (also referred to as an adverse experience) can be any unfavorable and 
unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally 
associated with the use of a drug, and does not imply any judgment about causality. An adverse 
event can arise with any use of the drug (e.g., off-label use, use in combination with another 
drug) and with any route of administration, formulation, or dose, including an overdose. 
 
9.1.1 Adverse Event Characteristics and Related Attributions 
CTCAE term (AE description) and grade: The descriptions and grading scales found in 
the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 
will be utilized for AE reporting. A copy of the CTCAE version 4.0 can be downloaded 
from the CTEP web site (http://ctep.cancer.gov). 
• 
Attribution of the AE: 
- Definite – The AE is clearly related to the study treatment. 
- Probable – The AE is likely related to the study treatment. 
- Possible – The AE may be related to the study treatment. 
- Unlikely – The AE is doubtfully related to the study treatment. 
- Unrelated – The AE is clearly NOT related to the study treatment. 
 
9.1.2 Recording of Adverse Events 
All adverse events will be recorded on a subject specific AE log. The AE log will be 
maintained by the research staff and kept in the subject’s research chart. 
 
9.1.3 Reporting of AE to WCM IRB 
All AEs occurring on this study will be reported to the IRB according to the IRB policy, 
which can be accessed via the following link: 
http://researchintegrity.weill.cornell.edu/forms_and_policies/forms/Immediate_Report 
ing_Policy.pdf. 

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9.1.4 Reporting Events to Participants 
Not applicable 
 
9.1.5 Events of Special Interest 
Not applicable 
 
9.1.6 Reporting of Pregnancy 
Not applicable 
 
10. Unanticipated Problems Involving Risks to Subjects or Others 
Not applicable 
 
10.1 Definition of Unanticipated Problems Involving Risks to Subjects or Others (UPIRTSO) 
Not applicable 
 
10.1.1 Unanticipated Problem Reporting 
Not applicable 

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