Self-Management Interventions: Considering Needs & Preferences of Dementia Caregivers
Phase: NA
Conditions: Stress, Carer Stress Syndrome, Dementia, Alzheimer's Disease, Bereavement
Sponsor: Case Western Reserve University

 
 
 

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[USE THIS SOCIAL, BEHAVIORAL, AND EDUCATIONAL PROTOCOL TEMPLATE IF YOUR 
PROJECT INCLUDES SURVEY, INTERVIEWS, FOCUS GROUPS OR EDUCATIONAL 
RESEARCH ACTIVITIES WITH NO BIOMEDICAL/CLINICAL COMPONENTS]
INSTRUCTIONS:
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Depending on the nature of what you are doing, some sections may not be applicable to 
your research. If so, please mark as N/A. You may delete contents of sections, but will not 
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PROTOCOL TITLE:
Self-Management Intervention: Considering Needs & Preferences of Dementia Caregivers 
(aka “Caregiver Career Study”) 
PRINCIPAL INVESTIGATOR
Jaclene Zauszniewski 
Nursing Science
216-368-3612
jaz@case.edu
UH FACULTY ADVISOR:
If the principal investigator’s primary role at UH is resident, fellow or student, identify a faculty 
advisor.
N/A
OTHER DEPARTMENTS INVOLVED IN THIS STUDY (IF APPLICABLE):
VERSION NUMBER:
Include the version number of this protocol if assigned by an outside entity. 
DATE: 
V1 
12/19/19 
V2
Updated 1.3.20 
V3
Updated 10.7.2020, 11.23.20
V4
Updated 2.18.21, 5.14.21
V5
Updated 8.29.22
V6
Updated 2.1.23

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Indicate the origin of this protocol (who conceived of and leads the development of the 
protocol regardless of funding):
Investigator initiated (Investigator(s) developed protocol, regardless of funding)
     Industry (Pharmaceutical, Device, etc.) (Industry developed protocol)
     Federal (NIH, DOD, etc.)
     Cooperative Group (SWOG, GOG, etc.)
     Other - Please specify:    
Funding
Objectives
Our primary aim is to examine the effects of a health self-management intervention 
(Biofeedback or Resourcefulness Training) delivered by need or preference in family carers of 
persons with dementia on caregiving responses (1a) and health outcomes (1b) over time. We 
hypothesize that family carers who receive either Biofeedback Training (BF) or Resourcefulness 
Training (RT) based on need or preference will have better health outcomes than carers in the 
attention control condition, regardless of caregiving phase. 
The second aim is to determine whether differences exist among caregivers, care partners, and 
caretakers in carer responses (2a) and health outcomes (2b) over time. All carers will complete 
measures of caregiving responses and health outcomes at baseline (T1), 6 months (T2), and 12 
months (T3). The four-week interventions will occur between T1 and T2 data points. Carers may 
use the intervention as often as they wish (i.e., self-tailoring); dosing and fidelity will be 
measured. Repeated measures bivariate and multivariate analyses will address the study aims 
while controlling for dementia symptom severity and caregiving demands.
Background
Directions: Describe the relevant prior experience and gaps in current knowledge describing
how it will add to existing knowledge. Include any relevant preliminary data.
Dementia is the most under recognized health crisis of the 21st century, with over 46 
million people worldwide living with dementia, a number that is expected to reach 131.5 million 
by 2050.4 In the United States, family members provide care for over 5.4 million elders with 
some form of dementia. Regardless of cause, dementia has a slow, progressive, fairly predictable 
downward course, with losses in mental and physical functioning that generate negative carer 
responses (i.e., perceived stress, depressive cognitions, negative emotions) and may seriously 
compromise the family carer’s health risks and physical and mental health (i.e., health 
outcomes). Research shows that within six months of a transition to a new caregiving phase (i.e., 
from caregiver, to care partner, to caretaker), the health of family carers shows evidence of 
substantial decline. Although researchers have identified factors occurring throughout the 
caregiving career that may adversely affect the carer’s health, interventions to promote health 
self-management by reducing negative caregiving responses have not been tested in carers who 
have recently transitioned into the role of caregiver, care partner, or caretaker. Consistent with 

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the Precision Medicine Initiative, which presents an innovative model that accounts for 
individual differences and empowers health care recipients (i.e., family carers) to participate 
actively in health care decisions, sustainable self-management interventions should be designed 
and tailored to match the carer’s needs and preferences and then tested with randomized, 
controlled trials.
There are several scientific premises underlying the fundamental assumptions of the 
proposed study: 
1) Having an elderly family member with any form of dementia is a devastating 
experience that takes its toll on other family members (i.e., spouses, adult children) 
who assume responsibility for their care and welfare; 
2) The caregiving career follows a long-term trajectory that may last from 4-20 years 
and involves a predictable downward spiral of losses in the elder’s mental and physical 
functioning, accompanied by changes in the level of care needed by the elder; 
3) Changes in level of care required to meet the needs of the elder over the course of 
dementia are reflected in a caregiving career comprised of the roles of primary 
caregiver (in the home), care partner (with facility placement), caretaker (following 
death of the loved one); 
4) Family carers, regardless of phase in the caregiving career, are prone to experience 
stress and depressive thoughts and feelings that can adversely affect their physical and 
mental health over time; and 
5) Existing interventions that strengthen family carer’s self-management skills, 
including Heart Rate Biofeedback (BF) and Resourcefulness Training (RT),© will 
reduce their stress, minimize their depressive feelings, and ultimately sustain their 
physical and mental health at any phase of the caregiving career. 
As the population >age 65 continues to age, the number of persons with Alzheimer’s 
and other forms of dementia is expected to escalate. More than 15 million family members 
provide some form of care or assistance for the over 5 million American elders who have some 
form of dementia.  Research shows that family carers provide more than 18 billion hours of 
informal, unpaid care for elders with dementia, constituting an annual cost to the nation that 
surpasses $221 billion.  In addition, the paid costs associated with health care, long-term care, 
and hospice for persons with Alzheimer’s and other dementias are estimated to be $214 billion 
each year, making dementia one of the most costly chronic illnesses in our nation. Although 
Medicare or Medicaid may cover up to 70% of the expenses, family carers assume remaining 
costs by paying out-of-pocket, contributing to additional stress on them. Thus, the tremendous 
societal burden associated with Alzheimer’s and other forms of dementia extends well beyond 
those who suffer from this devastating condition.
Systematic reviews have shown that researchers have examined interventions for 
dementia carers who are primary caregivers, including some that focused on reducing their 
stress or promoting/preserving health.  NIH-funded researchers have engaged in multi-site 
projects, Resources for Enhancing Alzheimer’s Caregiver Health (REACH), since 1995, and 
have tested educational support groups, behavioral care, skills training programs, family-based 
interventions, environmental modifications, computer-based information, and communication 
services. All of the interventions were found to be superior to control conditions for women 
versus men and for caregivers with lower versus higher education. Positive outcomes include 

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fewer depressive and anxious symptoms, greater satisfaction, and a better sense of well-being. 
These studies, however, were limited to one phase of the caregiving career, primary 
caregiving; interventions were not tested in care partners or caretakers, who are believed to 
experience similar stress levels and deleterious effects on health. In addition, the interventions 
tested within the REACH projects did not include the implementation of biofeedback as a 
means for stress reduction or the teaching skills that constitute resourcefulness as proposed in 
this study.
Only one study examined biofeedback in caregivers of persons with dementia and it 
found that biofeedback was feasible and effective for stress management in family caregivers. 
The study was missing a control group and the sample was very small (N=32) and limited to in-
home dementia caregivers whose care recipient attended a senior day care facility. However, 
systematic review of other intervention studies of dementia caregivers have described beneficial 
effects on caregiver health of such skills as cognitive reframing, problem-solving, self-
management, and help-seeking, all of which are incorporated within resourcefulness training. 
Consistent with the personal (self-help) and social (help-seeking) skills taught during
Resourcefulness Training, researchers have identified the need for interventions to assist 
dementia caregivers to seek out and mobilize social resources while enhancing personal coping 
effectiveness.
Resourcefulness Training (RT) has been found effective in reducing stress, depressive 
cognitions, and negative emotions, and improving mental and physical health in older adults and 
caregiver populations, including dementia caregivers. The PI’s pilot research with dementia 
caregivers shows they have a substantial need for resourcefulness skills as indicated by both 
subjective and objective measures, and that the RT intervention was found to be acceptable and 
feasible for dementia caregivers, particularly when it was tailored to meet their needs and 
preferences. The RT protocol with dementia caregivers was found to have implementation 
fidelity. Effect sizes on measures of caregiving responses (i.e., stress, depressive cognitions, and 
negative emotions) were found to be moderate to large when the dementia caregivers were given 
a choice in how they performed and reinforced resourcefulness skills
Seminal research suggests that the primary carer role for elders with dementia typically 
falls on the shoulders of the closest and most accessible family member (spouses, adult children), 
with the caregiving career being punctuated by significant events that prompt a transition in the 
caregiving career, which has been conceptualized in three phases. Few studies have examined the 
experiences of family carers in the three phases of the caregiving career. Those that have showed 
that the carer’s sense of control declined with in-home caregiving, stabilized during institutional 
placement, and improved after bereavement, and that carers in all three phases had different, 
unmet needs for assistance and informational support that contributed to similar stress levels. 
These studies support further investigation of dementia caregiving as a career with distinct 
phases designed to capture the carer’s responses to a recent transition into a new phase of the 
caregiving career. Research shows that within six months of a transition to a new caregiving 
phase (i.e., from caregiver, to care partner, to caretaker), the health of family carers shows 
evidence of substantial decline. To date, no studies of the three phases of the dementia caregiving 
career that examined the responses to recent transitions into a new phase of the career have been 
conducted. This study will be the first to do so.
Although the conceptualization of the dementia caregiving career dates as far back as 
1992, little research has been done to explicate the caregiving trajectory and transitions that occur 
during the progressive course of dementia. The preponderance of research on dementia 

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caregiving has focused on in-home caregivers, and has shown that despite interventions aimed at 
reducing negative outcomes, 59% of family carers continue to report emotional stress and 43% 
believe that caregiving significantly depleted their physical health. Research has also shown that 
family caregivers continue to be involved in various forms of care following institutional 
placement, a time when the family carer becomes a care partner. Care partners of 
institutionalized elders with dementia experience similar effects on their stress level and health as 
in-home caregivers, as their involvement in the care of their family member continues. However, 
while the source of their stress is now associated with different factors (communication 
challenges with staff, role conflict), their stress levels remain unchanged.
As the final stages of dementia culminate in the death of the loved one, family carers 
become caretakers. This caregiving career phase is typically overlooked, though caretakers may 
continue to experience stress and depressive thoughts and feelings that compromise their 
physical and mental health. As caretakers mourn their loss, they must engage in caring for their 
deceased loved ones in a new way (i.e., their belongings, property, estate). Thus, even as active 
caregiving ceases, effects of stress on health remain, losses and transitions continue, and 
caretakers must simultaneously rebuild their identity and sustain their health while experiencing 
bereavement. To date, research has not highlighted the importance of including the caretaking 
role as part of the caregiving career. However, one study that followed dementia caregivers for 
one year after their care recipients died found that almost half of the caregivers had clinically 
significant depression.
Based on the foregoing review, this study will: 1) include a sample of dementia carers 
that include caregivers (in-home), care partners (with a facility), and caretakers (bereaved) who 
have recently (within six months) transitioned into a new phase of their caregiving career; 2) 
examine the effects of two self- management interventions delivered to carers based on their 
need (cut score) or preference in comparison with an attention control condition; 3) explore 
differences in carers at the three phases of the caregiving career on caregiver responses to their 
recent transition and health outcomes over time; and 4) control for the effects of number of 
months in carer role, dementia symptom severity, and caregiving demands. As such, this will be 
the first study to investigate self-management interventions across all three phases of the 
caregiving career of dementia carers.
Inclusion and Exclusion Criteria
Directions: Describe how individuals will be screened for eligibility. Using the tables below, 
describe the inclusion and exclusion criteria that will define who will be included and 
excluded in your final study sample.
Inclusion
1.
At least 18 years old
2.
Have a living family member, or a recently deceased family member diagnosed 
with Alzheimer’s disease or another dementia 
3.
Identify self as a primary caregiver 
4.
In-home Caregivers: must be currently providing a minimum of 4 hours per day 
of supervision/direct care, and have entered that role within the past six twelve 
months;
Care partners whose family member moved into a nursing or assisted living 

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facility within the past six twelve months, and must report visiting their care 
recipient at least once per week (or have similar involvement with COVID-19 
restrictions). 
Caretakers (i.e. bereaved) whose family member is deceased within the past six 
twelve months, and are persons with direct oversight of the deceased person’s 
belongings, estate, finances, etc., and/or while their family member was alive, did 
they consider yourself a primary caregiver (whether care recipient was at home or 
in a facility).
5.
Be capable of performing informed consent and participating in study procedures
Exclusion
1.
Does not have family member with Alzheimer’s disease or another dementia
2.
Has not cared for a living family member with dementia within the last six twelve 
months, or the family member has been deceased for more than six twelve months
3.
Has knowledge of another family member in the same household enrolled in the 
study
4.
Currently pregnant
5.
Has a pacemaker
6.
Lives outside of the study area
Number of Research Participants
Directions: Indicate the target number of research participants to be accrued locally, and, if this 
is a multi-site study, indicate the total number of research participants to be accrued across all 
sites. 
Based on previous research by the PI and Co-Is, we conservatively estimate that ~20% of carers 
may not meet eligibility criteria. Thus, we will screen ~375 participants 600 individuals  to 
obtain the desired sample of size of 300 350. 
Special/Vulnerable Populations
1. Indicate specifically if you will include each of the following special populations by checking 
the appropriate box: 
Adults unable to consent
Minors (infants, children, teenagers) 
Wards of the state
Foster Children
Pregnant Women 
Neonates
Neonates of Uncertain Viability
Employees of CWRU or UHHS
Prisoners
Illiterate Individuals

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Non-English Speaking
University Students
None
2. If the research involves individuals that are included in a special/vulnerable population, 
describe the additional safeguards included to protect the rights and welfare of the 
individuals for each population indicated.
If family caregivers who do not speak/understand the English language come forward 
with interest in participating and if they meet all other study criteria, we will make 
accommodations for translating the study measures and intervention materials or for having 
and interpreter provide appropriate explanations. If an illiterate individual comes forward 
with interest in participating and if they meet all other study criteria, we will make 
accommodations to dictate the consent form and all study questions. If a caregiver is an 
employee or student of CWRU, the consent form identifies participation in this research 
study is voluntary and if they choose not to participate, it will not affect their current or 
future relations with the university. No caregivers unable to consent will be enrolled. Adults 
unable to consent are only subjects to the extent that there is any identifiable information 
about them collected through the caregiver. They will not be present for any interventions or 
interactions.
3. If excluding pregnant women, illiterate or non-English speaking individuals, provide a 
scientific rationale for the exclusion.  Inconvenience or cost is not an acceptable rationale.
Pregnant women are excluded due to the measure of heart rate variability (HRV). The 
inclusion of pregnant women has the potential to alter the analyses that involve HRV 
measurement.
Recruitment Methods
Note: Attach all applicable recruitment materials to the last section of the Smart form under 
“Recruitment Materials.”
1. Which of the following methods will be used to recruit research participants. – Select all that 
apply
  Email
  Phone call
  Letter
  Advertisement (e.g., poster, flyer, etc.)
  Social media
  Other. Please specify: 
2. Describe when, where, and how potential research participants will be recruited. 

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The 300 350 family caregivers will be recruited from Cuyahoga County, and 6 adjacent 
counties (Lorain, Medina, Summit, Portage, Geauga and Lake), as well as Erie, Huron, 
Ashland, Wayne, Stark, Mahoning, Trumbull, and Ashtabula counties. 
The potential research participants will be recruited through a variety of community-based 
strategies:
We will post flyers and distribute postcards in the community to recruit potential 
study participants, as well as recruit through social service advocacy agencies, and 
other community agencies.
We will contact dementia care day programs and care facilities, and private 
physicians’ offices who agree (with a signed Letter of Cooperation) to provide us 
with access for posting / distributing information about the study. Agency personnel 
may assist us in identifying potential study participants who meet the inclusion 
criteria. We may also recruit through these agencies with digital or printed ads in 
newsletters. 
We will collaborate with community agencies (e.g. senior centers) to conduct short 
presentations to interested audiences. Time permitting, we will utilize the NIH 
Recruiting Older Adults into Research (ROAR) open-source short form PowerPoint 
presentation (https://www.nia.nih.gov/health/recruiting-older-adults-research-roar-
toolkit) in addition to presenting information about our study (e.g. distributing flyers).
Health fairs and other community events.
We will recruit via the internet using social media sites (e.g. Twitter, Facebook, 
Instagram, and other online sources). We will also utilize paid digital and print 
advertising in local newspapers and other appropriate media outlets, including the use 
of advertorials and/or posted ads.  
Digital recruitment may include a link to a secure REDCap form so that people may 
leave their contact information for us to follow-up with. The form will include a brief 
description of the study.
Most potential study participants will be those who see a posted advertisement or 
receive a flyer describing the study from one of agencies, centers, dementia care 
facilities, offices, etc., where we have permission to post / distribute information 
about the study. Contact information for the research office will be included on the 
flyers, postcards, and other advertisements. Potential study participants will contact 
the research office for screening by a research team member to ensure he/she meets 
the eligibility criteria. If eligible, the research team member will confirm their name, 
contact information (phone and/or email), address, and time / best method for the 
research team to contact them, and proceed with the consent process and scheduling 
the first data collection session.
Finally, we will use snowball recruitment by asking study participants to refer others 
like them to the study. 
3. Describe the source (e.g., from what department, EMR, etc.) of the research participants.

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Potential study participants will be recruited through flyer postings, health fairs and other 
community events, print and e-newsletters (e.g. CASE Daily), community bulletin boards 
(both physical and virtual, e.g. Case Campus Groups), listservs, local magazines and 
newspapers, volunteer recruitment sites such as ResearchMatch.com and Alzheimer’s 
Association TrialMatch, both public and private advocacy agencies, care facilities, support 
groups, community health centers, and private physician offices in Cuyahoga and 6 adjacent 
other approved counties in Northeastern Ohio. 
To enhance recruitment of bereaved caretakers, we will also work with a large mortuary firm 
in Cleveland, known for its efforts to provide post-funeral support to bereaved families, as 
well as other mortuaries that serve the study area. We will also work with funeral homes, 
regional hospice agencies, bereavement support groups, and online obituary and memorial 
sites (e.g. Cleveland.com, legacy.com). Letters of Cooperation will be obtained from these 
agencies.
4. Describe the methods that will be used to identify potential research participants.
When a person contacts the study to be screened, they will receive a screening ID in the 
Screening & Enrollment log. Contact information will then be collected including date of 
initial contact, name, telephone number(s), email address(es), and mailing address on all 
individuals screened will collected for our screening log; this information will be stored in 
REDCap and a password-protected computer file (Box.com).
The project manager or other trained research staff will screen by phone to ensure that 
caregivers meet all eligibility criteria. We will also be collecting demographic information 
(gender, race, ethnicity, etc.). They will also be asked if they would like to be contacted 
regarding future research opportunities that may be of interest to them. All screening 
question documentation will be kept in a screening form on REDCap along with screening 
ID.
If the screenee is eligible:
After eligibility is verified during phone screening by team member, the consent will be 
reviewed verbally, questions about the study will be answered. They will be asked if they 
verbally consent to the study, with the understanding that the Consent Form will be reviewed 
and signed  prior to the first timepoint (T1) data collection. If they agree to participate, the 
research team member will then confirm and update any contact information into CWRU 
Box Screening and Enrollment Log and REDCap form; this includes the individual’s full 
name, mailing address, phone number(s), email address, best time of day to call, and 
confirming if the study team can leave voice mail messages, text to schedule / confirm study 
visits and intervention check-ins, and/or send mail to their mailing address if we are having 
trouble contacting them by phone or email. The study enrollment/first data collection 
appointment will be made at this time. 
If the screenee is not eligible/ declines verbal consent:

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If the individual does not meet the study criteria, they are asked if they would like to have 
their contact information kept on file in the event that the screening criteria are modified (e.g. 
study radius) and would like to be contacted to re-assess eligibility. If they say yes, the staff 
member will proceed to collect contact information in CWRU BOX and REDCap form 
(confirm full name, mailing address, phone number(s), email address). 
Screening data (questions asked to determine eligibility) is kept in the REDCap form in 
which it was entered in for tracking and reporting purposes.
5. Describe the feasibility of recruiting the required number of suitable research participants 
within the agreed recruitment period. For example, how many potential research participants 
do you have access to? 
Based on previous research by the PI, we conservatively estimate that 20% 45% 58% of 
caregivers may not meet eligibility criteria. Thus, we will screen ~375 ~550 600 individuals 
potential participants to obtain the desired sample size of 300 350. 
Setting
Directions: Make sure to describe: 1) sites and locations where your research team will conduct 
the research; 2) where your research team will identify and recruit potential research participants; 
and 3) include the physical location where research procedures will be performed.
The project manager or other research team member will screen by phone to determine 
eligibility and schedule first data collection meeting. All data will be collected either in the 
community (e.g. participants home or other private venue of their choice, including mental 
health center/physician’s office, private/ closed room in local library, etc.), on the campus of 
Case Western Reserve University (e.g. the School of Nursing).
COVID-19 Modifications: Consent, data collection, and intervention delivery has been 
modified to include virtual options: email, video chat (Zoom), phone, or some combination 
of the three, to meet study participants’ needs). This information is included throughout the 
protocol. 
Updated COVID-19 Modifications May 2021:  The study team will continue using virtual 
options when possible, but will also resume in-person study activities per the signed CWRU 
Safety Plan for In-Person Research Activities.
Potential study participants will be recruited through flyer postings, health fairs and other 
community events, print and e-newsletters (e.g. CASE Daily), listservs, local magazines and 
newspapers, volunteer recruitment sites such as ResearchMatch.com and Alzheimer’s 
Association TrialMatch, both public and private advocacy agencies, care facilities, support 
groups, community health centers, and private physician offices in Cuyahoga and 6 adjacent 
counties in Northeastern Ohio. 

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To enhance recruitment of bereaved caretakers, we will also work with a large mortuary firm 
in Cleveland, known for its efforts to provide post-funeral support to bereaved families, as 
well as other mortuaries that serve the study area. We will also work with regional hospice 
agencies, bereavement support groups, and online obituary and memorial sites (e.g. 
Cleveland.com, legacy.com). Letters of Cooperation will be obtained from these agencies.
Consent Process
Indicate whether you will be obtaining consent:
Yes
 No
If yes, answer the following questions:
Describe where the consent process will take place:
After eligibility is verified during phone screening by a team member the consent form 
will be reviewed verbally and questions about the study will be answered. Prior to 
initiating the first data collection, the consent form will be reviewed again and signed by 
both the study participant and data collector before beginning the data collection 
interview. 
COVID-19 remote modification: e-Consent, via REDCap Screening Project, will be 
emailed to potential participants for review e-signature and date after verbal review with 
team member. Once signed, a blank copy of the consent form is emailed to the participant 
via the REDCap e-consent framework, and a copy of the signed consent form is auto-
saved in the REDCap File Repository. This File Repository saves, with each file, the date 
and time of consent, the version of the consent form signed, and an IP address. Digital 
files of signed consent forms (ONLY) will be backed up and downloaded to a secure 
Box.com folder. Team members will have upload and view access, but will not be able to 
edit or delete files.
If a potential enrollee does not have email access at home, two consent forms will be 
mailed to them, along with a pre-stamped return envelope. They will be asked to sign, 
date, and return one copy, and to keep the second copy for their records. The 
corresponding data collector will sign and date the returned consent form.
The time that will be devoted to the consent discussion: 
There are no time constraints to the consent discussion. The consent discussion will take 
place during the screening phone call and again at the enrollment meeting, prior to data 
collection.
Any waiting period available between informing the prospective subject and obtaining 
the consent: 
Yes. After verifying eligibility and reviewing the consent form during the screening 
phone call, there is a period of time between the phone call and the enrollment meeting. 

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The length of time between the two varies depending on the meeting time selected by the 
research participant and team member.
COVID-19 remote modification: after phone screen and verbal review of consent form, 
e-consent will be emailed within 48 business hours. Study will utilized REDCap’s auto-
email reminder to send 3 reminders over the course of two weeks. After that, a team 
member will follow-up by phone/text/email (potential participant’s stated preference of 
communication) to see if they are still interested in joining the study. For consent forms 
mailed to the home, similarly timed follow-up will take place by phone (call/text) and/or 
email.
Steps that will be taken to ensure the research participants’ understanding: 
Study participants will have time to ask questions about the study and review the consent 
form before signing it.
Any process to ensure ongoing consent: 
Within approximately one month of the first data collection session, the participants will 
be made aware of which of the three study arms (Self-management need, self-
management preference, or attention control) to which they have been randomly 
assigned. They will be reminded of remaining study procedures and research staff will 
answer any questions regarding study procedures or participant concerns as they arise.
Steps that will be taken to minimize the possibility of coercion or undue influence to the 
subjects: 
The study participants will be informed that his or her participation in the research study 
is completely voluntary. If he or she chooses not to participate, it will not affect their 
current or future relations with the University or with physicians, mental health centers, 
or community venues from whom they may have obtained information about the study. 
Study participants will also be informed that there is no penalty of loss of benefits for not 
participating of for discontinuing participation in the study. 
For Adult Participants
Indicate if you will be asking for a waiver or alteration of consent process or 
documentation (consent will not be obtained, written consent will not be documented)
 Yes
No
If yes, indicate which part of the consent process you are requesting be waived or 
altered and the rationale for requesting the waiver or alteration:
I will obtain consent, but not participant’s signature
I will obtain consent, but request a waiver for pre-screening purposes

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 I will obtain consent, but request a waiver of some of the elements of consent 
(e.g. use of deception)
 I will not obtain consent, and I am requesting a full waiver of consent
Give the rationale for the request of a waiver or alteration of the consent process or 
documentation.      
N/A
Explain how the research involves no more than minimal risk.    
N/A
Explain why the waiver or alteration of consent will not adversely affect the rights and 
welfare of the participants.    
N/A
Explain why the research could not practicably be carried out without the waiver or 
alteration of consent.    
N/A
Indicate if the subjects will be provided with additional information about the study after 
participation.
N/A
If you will obtain consent, but not document consent in writing (e.g. over the phone, 
verbally, electronic survey, etc.), please describe and provide a rationale. 
  
 N/A   
Describe how you will be documenting that a research participant has consented.     
N/A
Additional Considerations for Consent Process with Adults
Non English Speakers (Please select one)
I am not enrolling non-English speaking individuals in this research study. The following is 
justification for why non-English speaking individuals cannot be enrolled: 
I will be targeting non-English speaking adults
Describe the process to ensure that the oral and written information provided to those 
research participants will be in that language during initial consent as well as throughout 
the study. 
List the language(s) other than English that will be targeted:  
I am not targeting non-English speaking individuals. If a non-English speaking individual is
eligible for the study, we will use the following procedures to enroll: 
1.
Describe the process to ensure that the oral and written information provided to those 
research participants will be in that language during initial consent as well as throughout 
the study. 

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If family caregivers who do not speak/understand the English language come forward 
with interest in participating and if they meet all other study criteria, we will make 
accommodations for translating the study measures and intervention materials or for 
having an interpreter provide appropriate explanations.
2.
List the language(s) other than English that will be targeted: 
Adults Unable to Consent
I am not enrolling adults unable to consent in this research study – please leave the rest of 
this section blank.
There is an anticipated direct benefit to the subject. Explain:
There is NOT an anticipated direct benefit to the subject. Explain:
No caregivers unable to consent will be enrolled. Adults unable to consent are only subjects to 
the extent that there is any identifiable information about them collected through the caregiver. 
They will not be present for any interventions or interactions.
1.
Describe the process to determine whether an individual is capable of consent.
Inclusion exclusion requires that the caregivers be caregivers of those with dementia and in 
addition a waiver of assent is requested.
2.
List the individuals from whom permission will be obtained in order of priority (e.g. 
durable power of attorney for health care, court appointed guardian for health care 
decisions, spouse, and adult child). 
Waiver is requested
3.
For research conducted outside of the state, provide information that describes which 
individuals are authorized under applicable law to consent on behalf of a prospective 
subject to their participation in the procedure(s) involved in the research.
 N/A  
4.
Describe the process for assent of the research participants. Indicate:
1.
Which subjects that are unable to consent will be required to give assent? If not all, 
explain why. 
Waiver is requested for all patients with dementia because they will not be present and it 
would be impractical to obtain it and the waiver will not impose on their rights or 
welfare. Patients with dementia will be living in a variety of places, and may not be able 
to be practically reached by phone or in person for giving assent solely for the purposes 
of collecting data about them (perceptions and observations by the caregiver) that may 
potentially identify them indirectly. The burden of attempting to gain an assent would be 
more harmful to these patients than any potential benefit. In addition, it would make the 
research project impractical and the benefits of the research justify the waiver of assent. 
There are suitable data security and other means of preserving confidentiality in place.

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2.
Describe whether assent of the research participants will be documented and the process 
to document assent. 
N/A; a waiver is requested. No interaction or intervention with those who are unable to 
consent.
The subject will be informed about the research to the extent compatible with the 
subject’s understanding.
 Subjects will be closely monitored.
 The subject will be withdrawn if they appear unduly distressed.
Research Participants Who Are Not Yet Adults (infants, children, teenagers)
  I am not enrolling participants who are not yet adults in this research study. – please leave the 
rest of this section blank
1.
Will parental permission be obtained from:
  One parent even if the other parent is alive, known, competent, reasonably 
available, and shares legal responsibility for the care and custody of the child
  Both parents unless one parent is deceased, unknown, incompetent, or not 
reasonably available, or when only one parent has legal responsibility for the 
care and custody of the child
  Requesting a waiver of parental permission
If you are getting parental/guardian permission:
1.
Indicate how you will be documenting the permission:
  Signed consent form
  Requesting a waiver of documentation of parental permission
2.
Describe whether permission will be obtained from individuals other than parents, and if 
so, who will be allowed to provide permission. Describe the process used to determine 
these individuals’ authority to consent to each child’s participation in research. 
If a waiver of parental permission is being requested:
1.
Describe how the study is designed for a subject population for which 
parental/guardian permission is not a reasonable requirement to protect the 
subjects, if applicable.
2.
Describe how the research could not practicably be carried out without the waiver 
of parental permission.
a.
Indicate if the subjects will be provided with additional information about the 
study after participation.
3.
Will assent be obtained from:

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  all of the children
  some of the children
  none of the children
If assent will be obtained from some children, indicate which children will be 
required to assent.
When assent of children is obtained, describe how it will be documented.
4.
For children who are pregnant, describe how assent and permission are obtained.
 N/A 
Sharing of Results with Research Participants
Results will be shared with research participants:
  Yes
 No
If yes, describe how the results will be shared.
Study participants will receive a one-page summary of the aggregated results by mail or 
email based on contact preference.  
Results will be shared with others:
  Yes
 No
If yes, describe with whom and how the results will be shared.
Aggregated results of the study will be shared with others through manuscripts and 
presentations.
Study Design/Procedures
Directions: 1) Describe the overall study design. 2) Provide a description of all study-
related research procedures being performed, including the length of time involved. 3) 
Include procedures being performed to monitor research participants for safety or 
minimize risks. 4) Describe the source records including medical or educational records, 
which will be used to collect data about subjects.
The proposed 1-year randomized controlled trial will compare the effectiveness of two 
tailored health self-management interventions (resourcefulness training and biofeedback) with 
usual care in family caregivers of persons with dementia. 
SCREENING: Prior to the first data collection session, the individual is screened over 
the phone. If the screenee is eligible, the consent form will be reviewed verbally, questions about 
the study will be answered. They will be asked if they verbally consent to the study, with the 
understanding that the Consent Form will be reviewed and signed electronically by an e-consent 
form, or if requested, a consent form will be mailed to the home for signature, date and return 
(envelope provided), and prior to the T1 data collection. If they verbally agree to participate, the 

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research team member will then confirm and enter contact information into CWRU Box and a 
REDCap form; this includes the individual’s full name, mailing address, phone number(s), email 
address, best time of day to call, and confirming if the study team can leave voice mail messages, 
text to schedule / confirm study visits and intervention check-ins, and/or send mail to their 
mailing address if we are having trouble contacting them by phone or email. The study 
enrollment/first data collection appointment will be made at this time. 
CONSENT: At the first meeting, before the T1 interview begins, the data collector will 
confirm receipt of signed consent form (digital or paper). All research staff (including the project 
manager, data collectors, and interventionists) will be required to complete the “human subjects” 
training and obtain certification prior to entering the field for data collection or intervention. The 
consent form will explain the expectations of caregivers as research participants, risks they may 
encounter, benefits they may accrue, measures to be taken to maintain confidentiality, and 
voluntary nature of their participation. Potential study participants will be told they are being 
asked to participate in a study to examine method for helping family caregivers to self-manage 
their health. They will be told that they will be randomly assigned (using a computerized system) 
to one of the three study arms (Self-management need, self-management preference, or attention 
control). They will be told the study involves 3 face-to-face interviews with a trained data 
collector during which objective, validated questionnaires and HRV measures will be completed, 
as well as an intervention (“stress management method”) between the first and second data 
collection interviews. The caregivers will be told that their confidentiality will be protected and 
that their names will not be revealed; results of the study will be reported in aggregate. They will 
be told that they are free to withdraw from the study at any point in time and that they do not 
need to supply responses to all questions posed on the study questionnaires. They will be told 
about the possible risk of feeling distressed while answering questionnaires or completing their 
daily logs, or using the biofeedback device (if applicable) and about measures that will be taken 
to minimize / manage the distress, including discontinuing participation and referral to mental 
health professionals if needed. They will be told that if a research team member, during a data 
collection or intervention meeting or call, suspects or witnesses any signs of elder abuse, neglect, 
or exploitation, a report will be filed with the county department of job and family services in 
compliance with Ohio law. They will be told about the potential benefit of stress reduction. 
Finally, they will be told that they will receive an incentive of a gift card valued at $20 at Time 
Point 1 (T1), $25 at T2, and $30 at T3. In addition, they will receive $20 for completing the face-
to-face or virtual intervention session and $5 for each week of completion of the progress log (up 
to 4 weeks or $20). Participants will receive up to $115 for completing all study activities.
DATA COLLECTION: Following informed consent, research staff will collect detailed 
contact information and schedule the first data collection session. During the COVID-19 
pandemic, data collection will be completed verbally over the phone and/or electronically 
(emailed survey, video chat) using REDCap. For phone or video data collection, an email will be 
sent, if possible and requested, to participants with the answer response choices for each survey 
(this can also be sent by mail). If we are using phone for data collection, the Research Assistant 
(RA) will ask the participant each question and record the responses in our REDCap Surveys 
project. If collecting data using Zoom video, the RA will share the screen of the REDCap 
Surveys project, and record the answers for the participant as they review each survey question. 

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If neither of those two options are available for the participant (e.g., limited phone minutes, 
inability to use Zoom), and/or email is preferred, the study may email the REDCap surveys to 
study participants for them to complete on their own at an agreed upon date / time (similar to in-
person appointment); in this instance, the RA can be available to answer questions or clarify 
information as needed, by phone or email. It may be that none of these options will work for a 
study participant, in which case we will consider that data “missed” if we cannot wait to collect 
the data in person at a later date (when we resume normal study activities). The precise 
method(s) will depend on the ability and resources of the study participant. We will contact 
active participants with Zoom/ phone instructions, by phone/text and/or email, as needed, and we 
will record the methods used for each data collection done remotely.
The data collection for caregivers sampled involves three structured face-to-face sessions with 
data collectors, each lasting typically 60-90 minutes.  Data will be collected at baseline (T1), at 4-
6 months (T2) after the 4-week intervention, and at 12 4-6 months later (T3). The data collection 
includes measures of carer health conditions, carer life events, health rating of care recipient, 
resourcefulness (including financial resourcefulness), dementia symptom severity, caregiving 
demands, carer responses to perceived stress, depressive cognitions, negative emotions, carer 
health outcomes, caregiving effort scales, and COVID-19 questions comprising the 158-225 item 
questionnaire (bereaved caretakers are not asked all study measures since they are no longer 
actively caring for their family member). Demographic information will also be collected (e.g. 
occupation, annual income, education, and questions about the care recipient such as age, number 
of years diagnosed with dementia, specific diagnoses, and questions related to the participant’s 
caring of their family member with dementia). The third, and final, data collection session 
involves the additional measure of an Intervention Evaluation Questionnaire that will ask 
participants for feedback regarding the intervention they received.
The table below shows which study instruments are administered at each time point:
Data Collection Instrument
Baseline / 
T1
4-6 months 
post-
intervention / 
T2
12 4-6 
months 
post-T2 / 
T3
Demographic and Descriptive Data*
X
X 
X
Health Rating of Elder Care Recipient**
X
X 
X
Cultural Justification for Caregiving
X
X
X
Resourcefulness Scale
X
X 
X
Financial Resourcefulness
X
Revised Social Readjustment Rating Scale
X
X 
X
Revised Memory and Behavior Problems Checklist**
X
X 
X
Perceived Stress Scale
X
X
X
Depressive Cognition Scale
X
X
X
Negative Emotions Checklist
X
X
X
Caregiver Appraisal of Functional Capacity**
X
X 
X
Health Risk Behavior Scale
X
X 
X
PROMIS Global Health Measures
X
X 
X

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Caregiving Effort Scales
X
X
X
Financial Stress
X
COVID-19 Questions
X
X
X
Intervention Evaluation Questionnaire
X
Heart Rate Variability
X
X 
X
* Questions 7-13 of the Demographics will NOT be asked to caretakers.
** These scales will NOT be asked to caretakers.
For in-person data collection: Research assistants will encourage caregivers to respond to 
items displayed on an iPad/ tablet as they wish, ensuring there are no right or wrong responses. 
Data is collected on an iPad through the REDCap Mobile App – which can be used when there is 
no wireless connection available. The data is stored securely in the app until it can be uploaded 
with a secure wi-fi connection (and then is removed from the iPad completely). IPads have a 
secure connection to login to the device, and another secure login to connect to the REDCap app. 
IPads are shut down completely at the end of every data collection session. At the first data 
collection session, the study participant will receive a resource list for Dementia Care support and 
services in Cuyahoga and surrounding counties.  
Heart-rate variability (HRV) data will be collected with a Byteflies or a similar HRV 
device, used either on the chest or on the wrists. Once a data collection (T1, T2, or T3) is 
complete, a team member will make an arrangement to collect HRV data at the study 
participant’s home or another agreed upon meeting location at a set day/time.
Remote HRV data collection: The participant will receive instructions of how to use 
the HRV device for 10-20 minutes data collection of HRV. The team member will be 
available to provide support during this time by phone or video call, and participants 
will be provided written instructions as well. There will be a pre-determined time set 
for pick-up of the device. If need be, this process may be repeated in order to obtain 
reliable data, and if this data is unable to be collected due to scheduling, it will be 
considered missing data for that time point.
In-Person HRV data collection: Following approved safety plan guidelines (May 
2021), a research team member will meet with the study participant to collect the 
HRV data in person. The data collection will take 10-20 minutes; the entire meeting 
should be completed within 30 minutes. Like remote data collection, this process may 
be repeated in order to obtain reliable data (not confirmed until data is analyzed by 
another team member). Currently enrolled participants will consent to this updated 
procedure.
INTERVENTION: Within two weeks of the first data collection session (including 
study scales and HRV data collection), carers within each of the three caregiving phases 
(caregivers, care partners, and caretakers) will be randomly assigned using a computer program 
to one of three treatment groups: 1) Self-management (SM) need, 2) Self-management (SM) 
preference, or 3) attention control. The SM-need group will receive a self-management 
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determined by whichever baseline cut score is lower, the Resourcefulness Scale or the SDNN 
parameter for age and gender. Carers randomly assigned to the SM-preference will choose to do 
RT or BF according to their personal preference. However, we will use minimization methods 
for group assignment to ensure equivalent representation across the three treatment groups, and 
factors likely to affect variables of interest, including carer age, gender, and race/ethnicity, in 
order to insure demographic similarity.
Carers in the SM-need and SM-preference groups will receive the training and practice a 
self-management intervention between the T1 and T2 data collections and may continue to use 
the intervention between T2 and T3 if they wish. The attention control (AC) condition, which 
consists of diversional activities, will also take place between T1 and T2 data collections. The 
RT, BF, or AC will be introduced during a single virtual session (Zoom, or iPad + phone call, 
depending on study participants ability / preference) during the COVID-19  pandemic, otherwise 
during a single face-to-face session in a mutually agreed upon private location. These 
intervention meetings last about 30-60 minutes and include a voice-over PowerPoint 
presentation, a summary of the information in a print brochure or electronic PDF, and a 
workbook (print or electronic) to be completed daily over 28 days, as they independently 
practice the intervention. RT participants will also be given a printed or emailed PDF list of 
examples (differ depending on caregiving type) from the training. The electronic workbook will 
be a form that is emailed daily over 28 days, but a print booklet will be provided for those that 
prefer it, and will be collected after 28 days. They will receive telephone, text or email follow-up 
(their preference) once per week for the 28-day intervention period while practicing the 
intervention (or activities) independently and keeping a daily workbook. Interventionists will be 
carefully trained by PI Zauszniewski and CNS Juratovac during a 2-day session that will include 
intervention delivery, cultural diversity training, and methods for providing psychological 
support/referral (e.g., “first call for help”) in case carers experience psychological or physical 
distress during the training session or 28-day intervention period. Interventionists will be blinded 
to fidelity measures and different interventionists will provide the RT, BF, or AC; they will keep 
field notes and have weekly supervision by CNS Juratovac and PI Zauszniewski, who has been 
trained in delivering biofeedback and has pilot-tested both interventions for feasibility and 
efficacy in similar populations. Commonalities during the single session for the RT, BF, or AC 
are: 
1) All carers will keep a progress log, though its content will differ by 
intervention/condition; 
2) All will be taught to indicate day and time of the log entry, with the suggestion to do it 
at the same time each day; and 
3) All will complete a log entry during the training session. 
Consistently, during the 4 weeks after the initial session: 
1) All carers will perform the assigned intervention (or activities) on their own,
2) All will have access to intervention/activity content for review as they wish, 
3) All will receive weekly follow-up calls/emails from interventionists (3-5 minutes) to 
remind them to follow respective intervention/activity protocols, and 
4) All will be encouraged to continue their logs even if days have been missed (although 
BF data may be missing).
Resourcefulness Training Intervention 

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Resourcefulness training involves teaching skills constituting personal (self-help) and 
social (help-seeking) resourcefulness.  The proposed method for teaching resourcefulness extends 
beyond simply teaching the skills to the caregivers of persons with dementia to facilitating the use 
of resourcefulness skills through self-reinforcement by daily tracking in a tracking log. Therefore, 
in this unique intervention, a mnemonic device will be used to facilitate recall of specific skills 
within the repertoire comprising resourcefulness. Three mnemonic techniques are used in (RT):  
acronyms, chunking, and practice.  The techniques are explained on the slides.
An acronym is formed by the first letter of words or groups of words to form a new word.  
In the case of RT, the mnemonic device uses the 8 letters spelling RESOURCE to prompt recall 
of specific personal and social resourcefulness strategies as follows:  
Rely on family / friends;  
Exchange ideas with others;  
Seek professionals or experts;  
Organize daily activities;  
Use positive self-talk;  
Reframe the situation positively; 
Change from usual reaction;  
Explore new ideas.  
The second mnemonic technique to be used in RT is chunking, which refers to the 
common rule that an individual can remember between 5 and 9 things at one time. In RT, the word 
RESOURCE contains 8 letters, which is a reasonable “chunk” of ideas of ideas for study 
participants to remember. Another way in which chunking is used is that the first three 
resourcefulness skills refer to social resourcefulness and involve help-seeking behavior, while the 
last five refer to personal resourcefulness and use self-help behaviors.  
The third mnemonic technique involves practice.  In this clinical trial, practice will be 
done through keeping a daily tracking log reviewing which strategies were used that day, along 
with review of a RESOURCE card and Resourcefulness Training pamphlet. Intervention recipients 
will choose the practice method they want to use.
Biofeedback Training Intervention
A proposed method of stress reduction for the family caregivers of persons with dementia 
disorder involves biofeedback that focuses on heart rate variability (HRV).  Through HRV 
biofeedback, one is able to learn how breathing patterns relate to changes in heart rate. HRV 
biofeedback has been found to be effective in reducing stress and enhancing relaxation.
The iRelax device is a small hand held device and contains a screen that displays one’s 
heart wave, similar to an EKG tracing.  Under each wave appears a bar that shows how well one 
is breathing in relation to heart rate.  With each breath, one can score 1 point or a fraction of it 
(1/3 or 2/3).  The device will beep with a minimum breath score of 2/3. The Interventionist will 
teach the caregivers:
1) How to turn the iRelax on and off.
2) Insert a finger into the sensor clip that detects their pulse rate. 
3) Inhale slowly and gently while observing the waves on the screen
4) Exhale slowly and gently while counting slowly from one to five when a new triangle 
appears above the wave

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5) Begin to inhale when the next wave starts to rise
6) How points are scored to show “heart rhythm coherence” - under each wave appears a 
bar that shows how well one is breathing in relation to heart rate.  With each breath, 
one can score 1 point or a fraction of it (1/3 or 2/3).  The device will beep with a 
minimum breath score of 2/3.
7) Use of a daily workbook to record daily points earned during the biofeedback session.  
The caregiver will be asked to describe his/her general emotional state each day and 
any specific stresses / frustrations he/she experienced in relation to the diagnosed 
family member. He/she will be asked to do this for the 4-week intervention period (28 
days). A Biofeedback breathing card and pamphlet (or electronic PDF) will also be 
provided to the participant.
Study Timeline (optional)
ClinicalTrials.gov Information
Directions: If this study has been registered on ClinicalTrials.gov, provide the ClinicalTrials.gov 
identifier and the investigator/sponsor responsible for registering. If this study has not been 
registered on ClinicalTrials.gov, provide the rationale as to why and if/when it will be. If it does 
not meet the requirement for being registered on ClinicalTrials.gov, please state that.
The study is approved on ClinicalTrials.gov. 
Clinical Trials.gov ID: NCT04603482
List of Data to be Collected
1.
Indicate what identifiers you will collect
Name
Address (e.g., Zip code, other geographical designation, etc.)
Dates related to an individual (e.g., Date of admission, birth, surgery, etc.)
Telephone number
Fax number
Email address
Social security number
Medical record number
Health plan beneficiary number
Account number
Certificate/license number
Any vehicle or other device serial
Device identifiers or serial numbers
Web URL
Internet protocol (IP) address
Finger or voice prints (includes audio recordings)
Photographic images (includes video recordings)

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Other: Any characteristic that would uniquely identify the individual
If other, please explain:
Heart rate variability requires non-invasive electrocardiography 
1. List all other data to be collected for the research study. Attach all data collection tools on 
the Local Site Documents page of the SpartaIRB smart form (Other Attachments). 
Demographics
Questionnaires to measure carer health conditions, carer life events, health rating of 
care recipient, dementia symptom severity, caregiving demands, carer responses to 
perceived stress, depressive cognitions, and negative emotions, financial 
resourcefulness and stress, carer health outcomes, and COVID-19 questions (Listed
under site related documents as ‘instruments & measures.pdf’)
Intervention evaluation questionnaire 
(Listed under site related documents as ‘CCS intervention eval questionnaire.pdf’)
Intervention workbooks 
(Listed under site related documents as ‘AC / BF / RT workbook page.pdf’
Data Analysis Plan
Directions: Describe the data analysis plan, including any statistical procedures. If applicable, 
provide a power analysis, and study/safety endpoints.
Prior to testing the study aims, demographic profiles for caregivers, care partners, and
caretakers will be created through univariate descriptive statistics, including means, standard 
deviations, and range of scores, and will be used to assess continuous data; frequencies and 
percentages will be used to describe categorical data. We will track the health conditions and 
the life events of all carers and dementia symptoms, level of care, and health rating of the care 
recipient for those who are not bereaved. However, the primary aim (Aim 1) is to test the 
effects of health self-management interventions (RT or BF) delivered based on need (i.e., cut 
score) or preference (i.e., personal choice) of dementia carers who have transitioned within six 
months to a new phase in the caregiving career (to at-home caregiver, to care partner with a 
facility, or to caretaker following the death of care recipient). Aim 1 is to compare carers who 
are randomly assigned to the need (SM-need, preference (SM-preference) group, or an 
attention control condition over 3 time points (baseline, 6 months, and 12 months) on carer 
responses (i.e., perceived stress, depressive cognitions, and negative emotions) (Aim 1a), and 
health outcomes (health risk, and physical and mental health) (Aim 1b). Aim 2 will focus on 
comparing caregivers, care partners, and caretakers. For Aims 2a and 2b, we will determine 
whether differences exist among caregivers, caregivers, care partners, and caretakers in carer 
responses (2a) and health outcomes (2b) over time. For all analyses, we will control for the 
effects of three covariates: months in caregiver, care partner, or caretaker role, dementia 
symptom severity, and caregiving demands.
For both study aims, we will use a 3 group by 3-time point Repeated Measures Analysis 
of Variance (RMANOVA), as well as 3 group by 3-time point Repeated Measures Analyses of 

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Covariance (RMANCOVA) to control for the three covariates on carer responses (i.e., 
perceived stress, depressive cognitions, and negative emotions) (Aim 1a and Aim 2a) and 
health outcomes (health risk, and physical and mental health) (Aim 1b and 2b). We will use 
both analyses in a two-step process: first, we will use RMANOVA to determine if mean 
differences exist among the 3 groups over 3 time points. If we find mean differences, for the 
second step we will run RMANCOVA to identify how the covariates impact the initial 
findings. This controls for any confounding effects of the covariates on the repeated measures 
models and will also allow us to determine how much of an impact the covariates have on 
carer responses and health outcomes.
The RMANOVA and RMANCOVA will allow us to not only assess mean differences 
across time, group differences, and the interaction of time X group in order to test the trend of 
the means over time across the SM- need, SM-preference, and attention control condition in 
Aim 1 and caregiver vs. care partner vs. caretaker in Aim 2. The RMANOVA and 
RMANCOVA not only can be used to determine if there are mean differences across the three 
time periods, but can also utilize orthogonal polynomial contrasts to determine whether linear 
and quadratic trends of the means across time are significant.
Confidentiality of Data
1.
To maintain the confidentiality of the data:
I will use a unique study identifier to code individuals’ identifiable data and will 
store the master list separate from the study data..
Other (please explain)
Provide a plan to destroy identifiers including how and when.
Identifiers in the Screening log (Box.com) and Contact Form (REDCap and CWRU 
BOX) will be destroyed after data collection is complete, and before the study is closed, 
by deleting the files.
How are you storing your electronic data?
UH Redcap
CWRU Redcap 
Secure Research Environment (SRE)
CWRU Box
OnCore
UH Secure Network Drive
CWRU Secure Network Drive
Other - List storage method and provide justification:
2.
Storage location of the paper research data and documents, if applicable:

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 Paper research data and documents will be stored in a double-locked secure 
environment in the following location: 
France Payne Bolton School of Nursing – Health Research Campus study office
3.
Will data be shared?
 Yes 
1.
List the exact data elements that will be shared:
2.
Describe how data will be sent:
 No
 N/A  
(Please note: if sharing data, please contact the UH Grants and Contracts Specialist or 
CWRU Tech Transfer Office to ensure the proper contracts/agreements are in place.)
HIPAA Authorization 
Does this study collect, access, use, or distribute any Protected Health Information (PHI)?
  Yes
  No
If yes, indicate how HIPAA authorization will be obtained (check all that apply):
  HIPAA authorization is in the consent form
  Requesting a full or partial waiver of HIPAA for prescreening
  I will complete the Request for Waiver of HIPAA Authorization form.  See 
SpartaIRB Library
  Requesting a full or partial waiver of HIPAA
  I will complete the Request for Waiver of HIPAA Authorization form.  See 
SpartaIRB Library
Devices
This is not device study. The protocol is considered non-therapeutic (non-therapeutic is defined 
as research not intended to diagnose, prevent, cure, mitigate, treat, etc. a disease or condition) 
by the FDA. – You may delete the rest of this section.
OR
This is a device study. The protocol is considered therapeutic (research intended to diagnose, 
prevent, cure, mitigate, treat a disease or condition) by the FDA. 
1.
Is there an IDE (Investigational Device Exemption) for the proposed study?
  Yes, provide an official letter of support or proof of approval which identifies the IDE 
holder and IDE number. 
  No

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2.
Is the device (and its use) a non-significant risk device for the proposed study design?
Yes
No 
N/A
3.
If the research involves device(s), describe your plans to use, store, handle, administer and 
track those device(s) to ensure that they will be used only on research participants and be 
used only by authorized investigators.
Risks to Research Participants
2.
List the reasonably foreseeable risks such as breach of confidentiality, discomforts, 
hazards, or inconveniences to the research participants related to their participation in the 
research. Include a description of the probability, magnitude, duration, and reversibility 
of the risks. Include the physical psychological, social, legal, and economic risks. 
No physical, psychological, social, legal, or economic risks other than associated with 
daily living, are expected for the carer who participates in this study. Thus, the risks for 
emotional/physical distress should be minimal. Several measures will be taken to minimize 
the potential risk for distress while completing study questionnaires, HRV measurement, or 
during the interventions that involve using a workbook about the use of diversional activities 
(the attention control), resourcefulness skills or breathing techniques, or use of the 
biofeedback device. If a carer becomes upset during a data collection interview or 
intervention meeting or phone call/email/text, the team member will offer to end it 
immediately, provide emotional support and/or make a referral to a mental health 
professional as needed. It is possible that discussion of stresses related to having a family 
member with dementia, or being recently bereaved, may stimulate emotional responses in the 
caregiver during the 4 week interventions. All weekly phone call/email/text field notes will 
be stored in Box or REDCap. In addition, there will be ongoing supervision by the 
intervention supervisor (Juratovic), who is an experienced, doctorally-prepared nurse. The 
data collectors and interventionists will report adverse effects to Dr. Juratovic and PI 
Zauszniewski as soon as discovered.   
With regard to the use of the HRV measuring instrument, there have been no reported 
safety risk with the use of this instrument. It has passed electromagnetic interference and 
compatibility tests. Thus, there is no danger of electric shock from use of the device. We let 
the individual know that the device is for research purposes only and not meant to be 
diagnostic, the data obtained from the device will record heart rhythm but will not give 
information about treatments needed for heart health. If the individual would like more 
information about heart health or risk, they will be encouraged to talk to their doctor. 
However, when analyzing their heart rate data, if the score indicates an irregularity with your 
heart rate or rhythm (e.g., SDNN <50ms), a study team member will contact the study 
participant as soon as possible, let the participant know that while the BioRadio reading is 
not diagnostic, their score indicates they may have some irregularity with their heart rate, and 
we will recommend that they follow-up with their health care provider at their earliest 
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3.
If applicable, indicate which experimental procedures may have risks to the research 
participants that are currently unforeseeable. 
 N/A  
4.
If applicable, describe the risks to others who are not research participants. 
 N/A  
5.
Describe the availability of medical or psychological resources that research participants 
might need. 
 N/A  
Provisions to Protect the Privacy Interests of Research Participants
Directions: Describe the steps that will be taken to protect research participants’ privacy 
interests.  (consider issues such as physical space, proximity to other, and participant 
preferences) 
After eligibility is verified during phone screening by a team member, we will confirm 
with all study participants whether or not we can leave a voicemail message on their phone(s), 
and whether or not we can send mail to their home (in the event we cannot reach them by phone, 
and/or if they are randomized to the control group). We will also ask if there are any disclosure 
concerns and make note if applicable in REDCap contact form and CWRU Box. 
Privacy language is included in the informed consent form. Participants have the option 
of withdrawing from the study at any time and can request that no further information be shared 
about them from that point on. Participant names will not be shared in any report of the finding 
or with other study participants. Data collection interviews and intervention sessions will be 
conducted virtually or in a private setting (i.e. participant’s home or other venue).  
Confidentiality will be assured during all phases of the project by the following 
procedures. Screening and Study ID numbers will be used for all caregivers. A list of screening 
and study ID numbers with identifying names, phone numbers, and addresses will be kept locked 
in password-protected files in Box.com and REDCap. The survey data will be kept in a separate 
file from the data collected during the study and will only be accessible to the PI and research 
staff that need access to assure accurate follow-up in this longitudinal study. This identifiable 
information will be destroyed after all data have been collected. 
Confidentiality issues will be addressed during training of research staff that will do the 
data collection and the interventionists. All data collected throughout the study, including signed 
consent forms, quantitative data using the REDCap system, HRV parameters, tracking logs, 
emails, and field notes maintained by research assistants and interventionists will be stored in 
locked files and password protected computer databases only accessible to the PI, Co-Is, project 
manager, and research staff. These data will not include any identifiable information that may 
have been obtained during recruitment and screening. These measures have been used 
successfully to protect the rights of human subjects in our previous studies. In addition, we will 
implement the following specific strategies to protect data obtained from the tracking logs or 
emails used by the caregivers:
1)    Structured workbook specific to intervention – carers will be provided with a 
structured workbook (electronic or print) for their use during the four week intervention 

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between the first (T1) and second (T2) data collection interviews. If provided a print 
copy, they will be instructed to store the workbook in a private place (known only to 
them) in their home during the four weeks. They will be directed to not use real names of 
friends, relatives, etc. within the workbook entries; they may use alternative names if they 
wish. Interventionists will review the workbooks immediately upon retrieval (after the 28 
day period) and if names are found, they will be blackened out and not appear within the 
transcribed text data files. The workbooks will be stored in a locked cabinet in the 
research office and the text files will be stored in a password protected computer 
database. Both the tracking log and text files will be kept for a period not to exceed 10 
years.
2)    Email - Individuals may use email to get more information about the study, and/or to 
contact staff once enrolled in the study. Email contacts and outcomes will be recorded 
generally on our contact forms in Box and/or REDCap. If an email needs to be printed or 
otherwise saved, it will be securely downloaded to a PDF file, with names and other 
contact information redacted, and delete the original email message. The PDF file will be 
stored in the password protected computer file for a period not to exceed 3 years.
Potential Benefit to Research Participants
   There is potential benefit to research participants.
Describe the potential benefits that individual research participants may experience from 
taking part in the research. Include the probability, magnitude, and duration of the 
potential benefits.
   There is no direct benefit to research participants.
If no direct benefit, state the potential benefit to society or others. Do not list 
compensation. 
Withdrawal of Research Participants
Directions: Describe the anticipated circumstances under which research participants will be 
withdrawn from the research without their consent. Also include the procedures that will be 
followed when a research participant withdraws or are withdrawn from the research, including 
partial withdrawal from procedures with continued data collection.
 N/A 
Participants have the option of withdrawing from the study at any time and can request 
that no further information be shared about them from that point on. If a study participant 
withdraws consent to participate in the study, a research team member will notify the project
manager to complete end of study documentation.
The project manager will review cases regularly with research staff to determine which 
study participants should be withdrawn from the study. Research participants will be withdrawn 
from the research without their consent if they are non-responsive to phone calls, emails, texts, or 
letters and considered lost to follow up. 
Data that were collected prior to a study participant’s withdrawal will be de-identified 
and still be used in the data analysis for the study. After withdrawal, no further data will be 
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Alternatives to Participation
Directions: List other options to participation.  If subjects will be compensated with extra course 
credit, the course instructor offering extra course credit must provide alternatives to earn extra 
course credit.  The alternative assignment must require equal or less time and effort for the same 
amount of earned extra credit that you can earn through participation in research.  If there are 
other available clinical treatments, what would be included if a subject continued on standard of 
care therapy. If there is a viable alternative you must list it in the consent.
   The alternative is for research subjects not to participate.
Costs to Research Participants
  There are no costs to research participants or their insurance companies (there are no clinical 
visits or billable procedures.) – You may delete the rest of the section.
1. Describe what costs research participants will be responsible for as a result of their 
participation in the research, including but not limited to: clinical services required by the 
protocol deemed billable to insurance, transportation to study visits, parking, costs of drugs, cost 
of therapy, lost broken or stolen devices, etc. 
2. Explain who will be responsible for payment of provided services in the event of insurance 
denials. 
3. List what procedures, drugs, devices, supplies will be paid by the study sponsor or covered by 
other funding. List the other funding source. 
Research Participant Compensation
  There is no compensation for research participants – please leave rest of this section blank
  There is compensation for research participants. 
Describe the schedule, payment method, and payment total of any incentives or 
compensation that research participants will receive for participation in the research (e.g., gift 
cards or cash with amount, t-shirts, devices, bags, swag, etc.)
Gift card incentives will be increased over time: $20 at T1, $25 at T2, and $30 at T3.  Carers 
will also receive a $20 gift card for the face-to-face intervention session and $5 gift cards for 
each week (up to 4 weeks/ $20) of completion of the workbook, distributed after the 28-day 
intervention time frame. Thus, each subject may receive up to $115 in gift card compensation 
for completion of all study activities.
  There will be reimbursement for research participants. 
Describe the schedule, payment method, and payment total of any reimbursement that 
research participants will receive for participation in the research (e.g., gift cards or cash with 
amount, etc.)

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If someone takes a bus or drives to CWRU or other community location to meet a research 
team member for T1, T2, T3, or an intervention meeting, we will reimburse that individual a 
2-trip bus pass or parking voucher as appropriate. 
Compensation for Research Related Injury
Describe who will pay for the costs of medical treatment and/or compensation in the event of a 
research related injury:
  
Funding agency is providing some/all payment for injury
  
Funding agency is providing no payment for injury
  
N/A 
Provisions to Monitor the Data to Ensure the Safety of Research Participants
1.
Describe how often the data will be monitored for completeness, accuracy and adherence 
to the protocol.
2.
Indicate if there will be a Data and Safety Monitoring Board or Committee:
There will not be a formal Data and Safety Monitoring Board/Committee.
There will be a formal Data and Safety Monitoring Board/Committee. 
Provide information about the DSMB/C including the contact information of the committee 
member(s) (as applicable); whether it is independent from the study sponsor; how often it 
meets; the type of data that will be used; written reports, etc.
A Safety Monitoring Committee (SMC) has been formed as the monitoring entity for this 
grant. The SMC is independent from the study sponsor and consists of:
Dr. Ronald Hickman , SMC chair, who serves as the Associate Dean for Research 
and is Associate Professor, Frances Payne Bolton School of Nursing, CWRU
Rlh4@case.edu 
Dr. Sara Douglas, Assistant Dean for Research, and Professor, Frances Payne Bolton 
School of Nursing, CWRU 
Sld4@case.edu 
Dr. Martha Sajatovic, Professor of Psychiatry from the CWRU School of Medicine, 
martha.sajatovic@UHhospitals.org   
Study team members will include Dr. Jaclene A. Zauszniewski, PI, and Dr. 
Christopher J. Burant, statistician cxb43@case.edu  
1. Monitoring Study Safety
a) Monitoring schedule - Twice per year throughout the project, the SMC will review data 
on the study regarding study safety. For example, the SMC will review any occurrences of 
carer emotional distress that required intervention by data collector or interventionist as 
well as those requiring referral and follow-up and instances where carers withdrew from 
the study.

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b) Audits for compliance with IRB requirements – Random internal audits of 10% of the 
files will be done twice annually to insure the approved IRB protocol is being followed. 
The SMC will review recruitment procedures, compliance with meeting the 
inclusion/exclusion criteria, consistency with random assignment process to the treatment 
conditions, provision of interventions within timeframe defined within the protocol, and 
scheduling of data collection sessions as outlined within the protocol.
c) Conformance with informed consent requirements – Random internal audits will be 
conducted twice per year to verify that informed consent requirements are being met.  For 
example, the SMC will review 10% of the consent forms for signatures and dates, make 
sure all consent forms are accounted for and stored in locked files and that the correct form 
is being used.  Data collectors will be asked to describe the consent process quarterly to re-
assess their knowledge of this process quarterly and review / retraining will be done as 
needed.
d) Verification of source documents – This study does not involve printed or written 
documents; data will be collected through electronic data capture using REDcap software 
and then downloaded directly into SPSSPC files. Heart rate variability data will be 
downloaded from the assessment device and transcribed into the SPSSPC files.  These 
sources will not include any data that would be personally identifiable. 
The SMC will review 1) all causes of mortality (e.g., carer death); 2) issues with 
participation (e.g., numbers and reasons for withdrawing from the study or refusing 
interventions, etc.) as well as recruitment refusal (percent and reasons) and subject attrition 
(percent and reasons); 3) missing data (including whether there are systematic patterns or 
whether data are missing at random); and 4) errors in data entry (which are expected to be 
minimal given the use of software for data collection with direct download into SPSS).  In 
addition, differential attrition from the intervention groups (including the control and usual 
care groups, and the groups assigned to intervention based on need or personal preferences) 
will be monitored. 
If concerns or problems are identified by the SMC, they will be reported to the IRB and 
NINR/NIH via email by Dr. Zauszniewski and Dr. Hickman, respectively, within 3 
business days after they are identified. If there are recommendations made by the SMC, the 
action plan for response or notice of any actions taken by the IRB regarding the research 
and any responses to those actions will be provided to NINR Officials within 2 weeks.
 
e) Investigator compliance – Compliance of the investigators and all research team 
members who will have access to the data will be monitored annually.  All research team 
members will be CREC certified; the CWRU intranet hosts a website where verification of 
compliance with continuing education for all investigators and team members can be 
evaluated.
2.) Reviewing and Reporting Adverse Events/unanticipated problems
 

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1. Event identification 
At the onset and for the duration of the study, all research staff and investigators will have 
instructional review of the nature and types of unanticipated and adverse events as described by 
the CWRU IRB. Potential risks for this study may include carer distress and breach of 
confidentiality (as described above). Carer distress may be identified by the data collector 
(during data collection) or the interventionist (during the interventions or phone follow-up). 
Breach of confidentiality may be identified by any research team member. 
2. Reviewing and reporting
As they occur, all unanticipated events and adverse events will immediately be reported 
to Dr. Zauszniewski (PI) who will report them to the IRB according the CWRU IRB protocol 
reporting procedures for both serious and non-serious adverse events  and unanticipated problem 
reporting. These will be summarized in the semi-annual reports to the SMC. Annual progress 
reports to the CWRU IRB and NINR/NIH will include a summary of the SMC’s activities and 
findings as well as any adverse events regarding human subjects. Program Officials at NINR will 
be informed in a timely manner (3 business days) of unanticipated problems (e.g., a data breach) 
or unexpected serious adverse events that may be related to the study protocol or IRB-approved 
revisions to the study protocol that indicate a change in risk for participants. All adverse events 
and protocol deviations will be reviewed with the staff involved within 3 business days.  Factors 
leading up to the event or deviation will be discussed and strategies for preventing recurrence 
will be developed and implemented immediately.
 
Community-Based Participatory Research
  
This is not a community-based participatory research project – please leave the rest of 
this section blank
This is a community-based participatory research project
Describe the involvement of the community in the design and conduct of the research.
 
Note: Community based research is research that is conducted as an equal partnership between 
academic investigators and members of a community. In Community Based Participatory 
Research (CBPR) projects, the community participates fully in all aspects of the research 
process.  
MULTI-SITE RESEARCH (when UH or CWRU is the IRB of Record)
Does this project have multiple sites?
  
Yes
  
No – please leave the rest of this section blank
Non-Local Site Information for Multi-Site Studies
If this is a multi-site study where you are the lead investigator, list the following information for 
each relying site:

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1.
Name of site: 
2.
PI of relying site: 
3.
Name of IRB contact: 
4.
Phone number of IRB contact: 
5.
Email address of IRB contact: 
Non-Local Recruitment Methods for Multi-Site Studies
If this is a multi-site study and research participants will be recruited by methods not under the 
control of the local site (e.g. call centers, national advertisements) describe those methods. 
Local recruitment methods are described above. 
1.
Describe when, where, and how potential research participants will be recruited. 
2.
Describe the methods that will be used to identify potential research participants. 
3.
Describe the materials that will be used to recruit research participants. 
Multi-Site Research Communication Plan (when you are the lead investigator)
If this is a multi-site study where you are the lead investigator, describe the processes to ensure 
communication among sites including:
  
All sites will have the most current version of the protocol, consent document, and 
HIPAA authorization     
 
All required approvals (initial, continuing review and modifications) have been obtained 
at each site (including approval by the site’s IRB of record)    
 
All modifications have been communicated to sites, and approved (including approval of 
the site’s IRB of record) before the modification is implemented    
 
All engaged participating sites will safeguard data, including secure transmission of 
data, as required by local information security policies
 
All engaged participating sites will safeguard data, including secure transmission of 
data, as required by local information security policies     
 
All local site investigators conduct the study in accordance with applicable federal 
regulations and local laws     
 
All non-compliance with the study protocol or applicable requirements will be reported 
in accordance with local policy     
If this is a multi-site study where you are the lead investigator, describe the method for 
communicating to engaged participant sites the following: 
1.   Problems:     
2.   Interim results:     
3.   The closure of the study:     
Additional Information
If you have any additional information regarding your study not covered in the template, please 
include it here.

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Study Information stored in Box.com:
Screening & Enrollment Log (screening ID, name, phone number and/or email, staff 
notes regarding eligibility status of individual, Study ID, Screen date, Informed Consent 
date, T1 date, Intervention date, T2 date, T3 date, End-of-Study date)
Uploaded HRV data
Copy of current informed consent form, and current protocol
Project Manager will keep REDCap back-up files (updated monthly) in Box.com. Files 
will be in SPSS format, and these separate files will be accessible only to the Project 
Manager and Data Coordinator.
Study Information stored in REDCap:
Screening form (criteria questions answered, verbal study consent, and consent for future 
research), Contact Form (name, address, phone number, preferred contact methods and 
times), eConsent (signed copies saved in File Repository, automatically includes IP 
address), Enrollment form confirming enrollment date, consent form signed digitally or 
paper copy; Randomization form with intervention assignment and End-of-Study forms. 
Study team members, depending on role, have access to different forms.
Interventions and Weekly meetings (different staff, depending on role, have access to 
different forms): Intervention tracking (date of intervention, weekly follow-up contact).
Surveys Project: All study instruments
Stored on Network drives:
No PHI is stored on network drives
Internal study files such as grant proposal, IRB folder, marketing materials.
References
1.
Alzheimer’s Association. (2016). Alzheimer’s disease facts and figures.  Alzheimer’s & 
Dementia,12(4),     22. http://dx.doi.org/10.1016/j.jalz.2016.03.001
2.  Gaugler, J.E., & Teaster, P.  (2006). The family caregiving career for community-based long-
term care practice and policy. Journal of Aging & Social Policy, 18(3/4), 2006, 141-154. doi: 
10.1300/J031v18n03_10
3.   Peacock, S.C., Hammond-Collins, K., & Forbes, D.A.  (2014). The journey with dementia 
from the        
perspective of bereaved family caregivers: A qualitative descriptive study. BMC Nursing, 13, 
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doi: 10.1186/s12912-014-0042-x
4.
Prince, M., Wimo, A., Guerchet, M., Ali, G.C., Wu, Y.T., & Prina, M. (2015). World Alzheimer 
Report 2015 The Global Impact of Dementia An analysis of prevalence, incidence, cost and 
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5.
Chiao, C.Y., Wu, H.S., & Hsiao, C.Y.  (2015). Caregiver burden for informal caregivers of 
patients with dementia: A systematic review.  International Nursing Review, 62, 340-250. 
doi: 10.1111/inr.12194

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6.
Gaugler, J.E., Anderson, K.A., Zarit, S.H., & Pearlin, L.I. (2004). Family involvement in 
nursing homes: effects on stress and well-being. Aging & Mental Health, 8(1), 65–75. doi: 
10.1080/13607860310001613356
7. Romero, M.M., Ott, C.H., Kelber, S.T.  (2014). Predictors of grief in bereaved family 
caregivers of persons with Alzheimer’s Disease: A prospective study. Death Studies, 38, 
395–403. doi: 10.1080/07481187.2013.809031
8. Bangerter, L.R., Liu, Y., & Zarit, S.H. (2017, online). Longitudinal trajectories of subjective 
care stressors; The role of personal, family, and dyadic resources. Aging and Mental Health. 
doi: 10.1080/13607863.2017.1402292
9.
Von Kanel, R., Mills, P.J., Mausbach, B.T., Dimsdale. J.E., Patterson, T.L., Ziegler, M.G., 
Ancoli-Israel, S., Allison, M., Chattillion, E.A., & Grant, I.  (2012a). Effects of Alzheimer’s 
caregiving on circulating levels of c-reactive protein and other biomarkers relevant to 
cardiovascular disease risk: A longitudinal study. Gerontology, 58, 354-365. doi: 
10.1159/000334219.
10. Von Kanel, R., Mausbach, B.T., Dimsdale. J.E., Mills, P.J., Patterson, T.L., Ancoli-Israel, S., 
Ziegler, M.G., Roepke, S.K., Chattillion, E.A., Allison, M., & Grant, I.  (2012b). Effect of 
chronic dementia caregiving and major transitions in the caregiving situation on kidney 
function: A longitudinal study. Psychosomatic Medicine, 74, 214-220. doi: 
10.1097/PSY.0b013e3182408c14.
11. Von Kanel, R., Mausbach, B.T., Ancoli-Israel, S., Dimsdale. J.E., Mills, P.J., Patterson, T.L., 
Ziegler, M.G., Roepke, S.K., Chattillion, E.A., Allison, M., & Grant, I.  (2012c). Sleep in 
Alzheimer’s caregivers: A longitudinal study with a focus on the effects of major patient 
transitions on sleep.  Sleep, 35(2), 247-255. doi: 10.5665/sleep.1632.
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caregiving. Journal of Gerontology: Psychological Sciences, 62(1), 38-44. 
13. Collins, F.S., & Varmus, M.D. (2015).  A new initiative on precision medicine.  New England 
Journal of Medicine, 372, 793-795. doi:10.1056/NEJMp1500523.
14. The White House (2015). Fact sheet: President Obama’s Precision Medicine Initiative.  
Retrieved from https://www.whitehouse.gov/the-press-office/2015/01/30/fact-sheet-
president-obama-s-precision-medicine-initiative.
15. Ryan, P., & Sawin, K. (2009).  The individual and family self-management theory: 
Background and perspectives on context, process, and outcomes. Nursing Outlook, 57, 
217-225. doi:10.1016/j.outlook.2008.10.004. 
16. UWM Self-Management Science Center Working Group. (2011). Individual and Family Self-
management Theory: Definition of self-management. Retrieved from 
http://www4.uwm.edu/smsc/framework/
17. Zauszniewski, J.A., Eggenschwiler, K., Preechawong, S., Roberts, B.L., & Morris, D.L.  (2006). 
Effects of teaching resourcefulness skills in elders. Aging and Mental Health, 10(4), 1-9. 
doi:10.1080/13607860600638446.
18. Zauszniewski, J.A., Eggenschwiler, K., Preechawong, S., Roberts, B.L., & Morris, D.L.  (2006). 
Effects of teaching resourcefulness and acceptance on affect, behavior, and cognition of 
chronically ill elders.  Issues in Mental Health Nursing, 28(6), 575-592.
doi:10.1080/01612840701354547.
19. Zauszniewski, J.A., Musil, C.M., Au. T.Y., Burant, C.J., & Standing, T.S.  (2014). 
Resourcefulness training for grandmothers raising grandchildren: Establishing fidelity. 
Western Journal of Nursing Research, 36(2), 228-244. doi:10.1177/0193945913500725. 
20. Zauszniewski, J.A., Musil, C.M., Burant, C.J., & Au, T.Y. (2014). Evidence for preliminary 
effectiveness of resourcefulness training interventions for grandmothers raising 
grandchildren. Research in Nursing and Health, 37(1), 42-52. doi: 10.1002/nur.21574.

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21. Zauszniewski, J.A., Lekhak, N., Morris, D.L., Burant, C., & Underwood, P.  (2016). 
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