Tailored Health Self-Management Interventions for Highly Distressed Caregivers: Family Members of Persons With Dementia
Phase: NA
Conditions: Stress, Carer Stress Syndrome, Dementia, Alzheimer Disease
Sponsor: Case Western Reserve University

PROTOCOL TITLE: 
 Tailored Health Self-Management Interventions for Highly Distressed Caregivers: Family Members of 
Persons With Dementia 
 
 
Identifiers: NCT04247347 
Unique Protocol ID: 3R01NR01S817‐04S1 
 
 
PRINCIPAL INVESTIGATOR  
Jaclene Zauszniewski  
Nursing Science  
216-368-3612  
jaz@case.edu 
 
Document Date: 6/30/2021 

Page  1 of 28 
 
 [USE THIS SOCIAL, BEHAVIORAL, AND EDUCATIONAL PROTOCOL TEMPLATE IF 
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EDUCATIONAL RESEARCH ACTIVITIES WITH NO BIOMEDICAL/CLINICAL 
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PROTOCOL TITLE:  
Tailored Health Self-Management Interventions for Highly Distressed Caregivers: Family 
Members of Persons with Dementia  
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:  
8/7/2019  
updated 11/20/19  
updated 3/2/20 and 6/29/20  
updated 8/19/20  
updated 1/6/21 and 4/26/21  
updated 6/30/21 
 
 

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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  
The AIMS of this supplement are:  
1. to examine the effectiveness of two health self-management interventions 
(resourcefulness training and biofeedback) in comparison with usual care (education) on 
the study outcomes specified in the parent study IRB-2016-1651 (health risks and 
physical and mental health from pre- to post-intervention) for caregivers of persons with 
dementia sampled in this supplement;  
2. to compare the responses to resourcefulness training, biofeedback, and education 
program of these caregivers with caregivers of persons with bipolar disorder (from 
parent study) on the three outcomes over time; and  
3. to explore similarities or differences between the two types of caregivers in terms of 
their need for intervention (determined by baseline cut scores on study measures) and 
preference for intervention (response at end of study). Family caregivers of persons with 
dementia will complete validated study measures at baseline and within one month 
following intervention.  
 
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.  
 
Recent statistics show that nearly 35 million family members in the United States 
provide unpaid care to an adult with a disability or illness. Close to 72% of these 35 million 
family caregivers care for adults with psychological or behavioral conditions known to be 
highly distressing.  
While family caregivers of persons with bipolar disorder, the focus of our parent 
study, exceed 10 million, the number of family caregivers of persons with Alzheimer’s 
disease or related dementias is even greater. 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 
caregivers provide more 
 
 

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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 caregivers 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.  
The trajectories of the two conditions differ: caregivers of persons with bipolar 
disorder experience the fluctuating moods, intensity, and unpredictability of bipolar disorder, 
caregivers of persons with Alzheimer’s disease or related dementias (hereafter referred to as 
dementia) face a predominantly downward spiral of dementia symptoms and course of 
illness. Although both groups of caregivers are known to be highly distressed, to date, there 
are no published comparative studies of caregivers of persons with bipolar disorder and 
caregivers of persons with dementia. But there is no doubt that both types of caregivers are 
highly distressed and can benefit from tailored health self-management intervention. The 
findings from this study have the potential to generate new scientific knowledge about the 
effectiveness of novel, easy to use, independently performed interventions that can be self-
tailored to promote caregiver health through education, biofeedback, or resourcefulness. 
Once established, these health self-management interventions can be tailored to match the 
needs and preferences of other comparably distressed family caregivers of persons with other 
chronic mental or physical conditions.  
 
There are several scientific premises underlying the fundamental assumptions of the 
proposed study.  
1. having a 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 the care and welfare of the care recipient.  
2. The caregiving career follows a long-term trajectory that may last from 4 to 20 
years and involves a predictable downward spiral of losses in the care recipient’s 
mental and physical functioning accompanied by changes in the level of care needed.  
3. Changes in level of care required to meet the needs of the care recipient over the 
course of dementia are reflected in a caregiving career comprised of the roles of 
primary caregiver (in the home) and care partner (with facility placement).  
4. Family caregivers are prone to experience stress that can put their own health at 
risk and adversely affect their physical and mental health over time.  
5. Interventions that strengthen a family caregiver’s self-management skills will 
reduce their stress and ultimately sustain their physical and mental health over time.  
 
Systematic reviews have shown that researchers have examined interventions for 
dementia caregivers who provide care in the home, 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. 
They have tested educational support groups, behavioral care, skills training programs, 
family-based 
 

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interventions, environmental modifications, computer-based information, and communication 
services. All of the interventions were found to be superior to control conditions for female 
versus male caregivers and for caregivers with lower versus higher education. Positive 
outcomes include fewer depressive and anxious symptoms, greater satisfaction, and better 
sense of well-being. These studies, however, were limited to caregivers of persons with 
dementia in the home and did not include caregivers whose family member was living within 
a facility as proposed in this study. Thus, the interventions were not tested in those 
caregivers, 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 and of such skills as cognitive reframing, 
problem-solving, self-management, and help-seeking, all of which are included in 
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.  
The findings from this study have the potential to generate new scientific knowledge 
about the effectiveness of novel, easy to use, independently performed interventions that can 
be self-tailored to promote caregiver health through education, biofeedback, or 
resourcefulness. Once established, these health self-management interventions can be 
tailored to match the needs and preferences of other comparably distressed family caregivers 
of persons with other chronic mental or physical conditions.  
 
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. 
 

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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 
caregivers may not meet eligibility criteria. Thus, we will screen 125 participants to obtain 
the desired sample of size of 100.  
 
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  
☒ Non-English Speaking  
☒ University Students 
 
 

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☐ 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.  
 
The 100 family caregivers will be recruited from Cuyahoga County and 6 adjacent 
counties through social service advocacy agencies, community agencies, dementia care 
day programs and care facilities, and private physicians’ offices who agree 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 following inclusion 

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criteria: caregivers will be at least 18 years old, report having a family member with 
dementia, and providing care or support for them for at least 6 months, but not 
necessarily in the same household (i.e. they may be living in a dementia care facility). 
However, we anticipate that most of the 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. 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 team member will obtain their name, contact information (phone and/or 
email), address, and time / best method for the data collector to call to make an 
appointment to meet to discuss and enroll in the study, obtain their informed consent to 
participate, and conduct their first data collection interview.  
 
In addition, agency personnel/health care professionals may nominate a caregiver for the 
study. We will use snowball recruitment by asking study participants to refer others like 
them to the study. We will also recruit via the internet using social media sites (e.g. 
Twitter, Facebook, Instagram, and other online sources).  
 
3. Describe the source (e.g., from what department, EMR, etc.) of the research participants.  
 
Potential study participants (who meet the study criteria) will be recruited through both 
public and private advocacy agencies, care facilities, support groups, community health 
centers, health fairs and other community events, print and e-newsletters (e.g. CASE 
Daily), listservs, local magazines and newspapers, ResearchMatch.com, Alzheimer’s 
Association TrialMatch, and private physician offices in Cuyahoga and 6 adjacent 
counties in Northeastern Ohio.  
 
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 and 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 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.). All individuals that are screened and asked 
questions to see if they meet eligibility criteria. At the end of the screening, they will be 
asked if they would like to consent to be contacted for future research opportunities 
(those that enroll in the study will also be asked if they consent for future research with 
the informed consent form). All screening question documentation will be kept in a 
screening form on REDCap along with screening ID.  
 
After eligibility is verified during phone screening by team member, the consent form 
will be reviewed verbally, and questions about the study will be answered. The research 
team 
 

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member will then confirm and enter contact information in REDCap, as well as update 
the Box Screening and Enrollment Log; 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  
 
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% caregivers 
may not meet eligibility criteria. Thus, we will screen 125 potential participants to 
obtain the desired sample size of 100.  
 
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).  
 
Study participants (who meet the study criteria) will be recruited through both public 
and private advocacy agencies, care facilities, support groups, community health 
centers, health fairs and other community events, print and e-newsletters (e.g. CASE 
Daily), listservs, local magazines and newspapers, ResearchMatch.com, Alzheimer’s 
Association TrialMatch, and private physician offices in Cuyahoga and 6 adjacent 
counties in Northeastern Ohio.  
 
Consent Process  
Indicate whether you will be obtaining consent:  
☒ Yes ☐ No  
If yes, answer the following questions:  
1. 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. The consent form will also ask if they consent to be contacted for future 
research opportunities (5/10/21). 
 

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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, data collector will be notified by email and will add 
their signature and date to the e-consent form. Current participants will re-consent 
electronically. Digital files of signed consent forms will be 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.  
 
Updated COVID-19 Modifications June 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. An updated consent script 
will be emailed or read over the phone (for those with no email) informing already 
enrolled participants of updates to the Informed Consent Document and study 
procedures (6/30/21).  
 
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. If an in-
person data collection session is scheduled, the data collector may obtain signed 
informed consent at that time (6/30/21).  
 
2. 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.  
 
3. 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. 
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 hours. Study will utilize REDCap’s auto-email 
reminder to send up to 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.  
 
4. Steps that will be taken to ensure the research participants’ understanding:  
 

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Study participants will have time to ask questions about the study and review the consent 
form before signing it.  
 
5. 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 groups (education/ usual care, resourcefulness, 
and biofeedback) 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.  
 
6. 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  
☐ 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  
1. Give the rationale for the request of a waiver or alteration of the consent process or 
documentation.  
 
N/A  
2. Explain how the research involves no more than minimal risk.  
 
N/A  
3. Explain why the waiver or alteration of consent will not adversely affect the rights and 
welfare of the participants.  
 
N/A  
4. Explain why the research could not practicably be carried out without the waiver or 
alteration of consent.  
 
N/A 
 
 

Page  11 of 28 
 
 
5. Indicate if the subjects will be provided with additional information about the study after 
participation.  
N/A  
6. 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  
7. 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  
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.  
 
2. 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.  
 
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.  
 
 

Page  12 of 28 
 
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.  
 
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 
 

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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:  
 
☐ 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. 
 

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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.  
Before the T1 interview, the data collector will obtain the caregiver’s written informed 
consent to participate. 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 treatment conditions. They will be told the study 
involves 2 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 $20 at T1 and 
$25 at T2. In addition, they will receive $20 for completing the face-to-face intervention 
session and $5 for each week of completion of the progress log (up to 4 weeks or $20). 
Participants will receive up to $85 for completing all study activities.  
Following informed consent, research staff will collect detailed contact information and 
schedule the first data collection session. The data collection for caregivers sampled involves 
two structured face-to-face sessions with data collectors. Data will be collected at baseline 
(T1) and within one month after the 4-week intervention (T2). Measures include dementia 
symptoms, caregiver reactions, caregiving involvement, dementia knowledge, 
resourcefulness, heart rate 
 

Page  15 of 28 
 
variability, health risks, and health outcomes, comprising the 156-item questionnaire. 
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). 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. 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.  
Within two weeks of the first data collection session, caregivers will be randomly 
assigned using a computer program to one of the three interventions (usual care/ education, 
resourcefulness, or biofeedback). Caregivers will receive the training and perform one health 
self-management intervention between the T1 and T2 data collections. The education, 
resourcefulness training, or biofeedback training will be introduced during a single face-to-
face session in the caregiver’s home/other private venue via a voice-over PowerPoint 
presentation presented on a tablet. All 90 caregivers who receive an intervention or usual 
care will keep a written log for the 4-week intervention period between the first (T1) and 
second (T2) data collection interviews. The caregivers will receive a pamphlet on their 
intervention (based on the PowerPoint presentation), a tracking log, and will received 
telephone, email or text follow-up (preference of the study participant) for the next 28 days 
while performing the intervention independently and at their convenience. Interventionists 
will be carefully trained by Drs. Zauszniewski and 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 caregivers 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 
education, resourcefulness training, and biofeedback; they will keep field notes and have 
weekly supervision by Dr. Juratovac.  
The first data collection session involves the additional measures of Financial Stress 
& Resourcefulness, and the second data collection adds an Intervention Evaluation 
Questionnaire that will ask participants for feedback regarding the intervention they 
received. Participants randomized to the Resourcefulness Training will be asked to complete 
the RT Skills Scale as part of the Intervention Evaluation Questionnaire.  
COVID-19 remote modification – Beginning in July 2020, participants will provide 
e-consent via REDCap vs. written consent in person. If a person does not have email or 
would prefer to sign a paper consent form, two copies of the consent form will be mailed to 
their home, with instructions to sign and date both, and return one copy to the study office 
with the addressed and stamped envelope that is also provided (see page 9). Current 
participants will re-consent electronically. Enrolled study participants will have the option to 
download a copy of the consent form for their records, or it can be mailed / emailed to them 
(participant preference).  
Updated COVID-19 Modifications June 2021: If an in-person data collection session is 
scheduled, the data collector may obtain signed informed consent at that time (6/30/21).  
The two face-to-face interviews will instead consist of two remote data collection 
session. We will use phone (Google voice), Zoom (computer video), and/or email to complete 
the data 
 

Page  16 of 28 
 
collection. 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. 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.  
Heart-rate variability (HRV) data will be collected with the Byteflies or a similar 
HRV device. Once a data collection (T1 or T2) is complete, a team member will make an 
arrangement to collect HRV data at their home or another agreed-upon location at a set day 
and time.  
• Remote HRV data collection: The participant will receive instructions of how to 
use the HRV device for a 20-30 minute data collection of HRV; this instruction sheet 
will also include safety information. The team member will be available to provide 
support during this time by phone or video call. The data collection may happen at 
the time of drop-off or sometime that day. 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 (June 
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.  
 
Delivery of the intervention will also be conducted remotely. After randomization, an 
intervention team member will schedule a 45-minute video call to present the intervention. 
This meeting will include a power point presentation, a review of the online tracking log, and 
instructions for the 28-day intervention period. An electronic copy of the corresponding 

Page  17 of 28 
 
the study participant.  
Gift cards will replace in-person cash compensation throughout the study period.  
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.  
NCT04247347 Jaclene A. Zauszniewski  
List of Data to be Collected  
• 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)  
☒ 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).  

Page  18 of 28 
 
 
• Questionnaires to measure dementia symptoms, caregiver reactions, caregiving 
involvement, dementia knowledge, resourcefulness, health risks, health outcomes, and 
financial stress and resourcefulness. (Listed under site related documents as ‘instruments 
& measures.pdf’)  
• Intervention evaluation questionnaire  
(Listed under site related documents as ‘DCS intervention eval questionnaire.pdf’)  
• Intervention tracking logs  
(Listed under site related documents as ‘resourcefulness sample tracking log page.pdf’, 
‘biofeedback sample tracking log page.pdf’, ‘dementia education sample tracking log 
page.pdf’)  
• COVID-19 questionnaire at T1 and T2  
 
Data Analysis Plan  
Directions: Describe the data analysis plan, including any statistical procedures. If applicable, 
provide a power analysis, and study/safety endpoints.  
 
The primary study aim (Aim #1) is to examine differences across our three groups of family 
caregivers of persons with dementia on caregiver health outcomes from pre- to post-
intervention. The underlying analyses for A1 are built around the repeated measures analysis 
of variance (RMANOVA). The primary analysis will be a three group × two time waves 
RMANOVA. These analyses will compare the three groups: 1) usual care (education), 2) 
resourcefulness, and 3) biofeedback across two time waves of health risks and physical and 
mental health outcomes. When using RMANOVA, one not only assesses mean differences 
across time, but also group differences and the interaction of time × group, which will allows 
us to test the trend of the means over time across the three groups. The RMANOVA, not only 
is used to determine if there are mean differences across the two time periods, it also uses 
orthogonal polynomial contrasts to determine linear trends of the means across time. 
Orthogonal polynomials are weights assigned to each time period that models a linear trend. 
RMANOVA will determine if these trends in the means are significant. A linear trend is 
indicated if there is a steady increase or decline in scores from the first time wave to the 
second time wave.  
 
The second aim (Aim #2) identifies the responses to usual care (education), resourcefulness 
training, and biofeedback separately on the three health outcomes between the caregivers of 
persons with dementia sampled within the proposed administrative supplement with the 
caregivers of persons with bipolar disorder sampled in the parent study. This aim involves 
three separate analyses to compare the two groups of caregivers within each of the three 
treatment groups (education, resourcefulness training, and biofeedback) for each of the three 
health outcomes. For each intervention/treatment program, a two group by two time point 
RMANOVA will be used to determine differences within and between groups and the 
interaction of time × group. For example, one RMANOVA will examine differences between 
caregivers of persons with dementia and caregivers of person with bipolar disorders on 
health risks over two time points.  
 
The third study aim (Aim #3), to explore differences between the two groups of caregivers in 
terms of their need for intervention (determined by baseline cut scores on study measures) 
and 
 

Page  19 of 28 
 
preference for intervention (response at end of study), as these outcomes are categorical (i.e., 
education group, resourcefulness training group, or biofeedback group), we will use chi 
square analyses to determine the extent to which caregivers of persons with dementia differ 
from caregivers of persons with bipolar disorder separately for their need group and for 
their preference group in health self-management interventions.  
 
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.  
 
2. 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:  
3. Storage location of the paper research data and documents, if applicable:  
 
☒ Paper research data and documents will be stored in a double-locked secure 
environment in the following location:  
France Payne Bolton School of Nursing study office  
 
4. 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 
 

Page  20 of 28 
 
☐ 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  
 
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  
1. 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 caregiver 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 tracking 
logging about the use of education, 
 

Page  21 of 28 
 
resourcefulness skills or breathing techniques, or use of the biofeedback device. If a 
caregiver 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 may stimulate 
emotional responses in the caregiver during the 4 week interventions. All weekly phone 
call/email/text field notes will be stored in 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.  
 
In regard to the use of the HRV measuring instrument, there have been no reported safety 
risk with the use of this instruments. 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.  
 
2. If applicable, indicate which experimental procedures may have risks to the research 
participants that are currently unforeseeable.  
 
☒ N/A  
 
3. If applicable, describe the risks to others who are not research participants.  
 
☒ N/A  
 
4. 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.  
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 in a private setting (i.e. participant’s home or other venue). 

Page  22 of 28 
 
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 tracking log specific to intervention/ stress management method – 
caregivers will be provided with a structured tracking log for their use during the 
four week intervention between the first (T1) and second (T2) data collection 
interviews. If they receive a paper copy of the tracking log, versus completing an 
online log, they will be instructed to store the tracking log 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 tracking log entries; they may use 
alternative names if they wish. Interventionists will review the tracking logs 
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 tracking 
logs 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 3 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, which use Study ID number and not names. 
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.  
 
COVID-19 remote modification:  
Tracking logs will be sent electronically, but the option will remain to send a paper 
copy to the study participant, to be collected after the 28-day intervention.  
Prior to a scheduled phone or video call with a participant, we will encourage them 
to find a quiet / private place to talk. At the beginning of each phone or video call, the team 
member will confirm that it’s a good time to meet virtually, and ask who is in the room with 
them / confirm that they are able to talk with the study team member. 
 

Page  23 of 28 
 
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 collected for that participant.  
 
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. 
 

Page  24 of 28 
 
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.)  
 
Incentives will be increased over time: $20 at T1 and $25 at T2. Caregivers will also receive 
$20 for the face-to-face intervention session and $5 for each week (up to 4 weeks/ $20) of 
completion of the progress log. Thus, each subject may receive up to $85.  
 
COVID-19 remote modification: Gift cards equal to the cash amount will be sent to study 
participants after completion of the identified 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.)  
 
If someone takes a bus or drives to CWRU or other community location to meet a research 
team member for T1, T2, 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. 

Page  25 of 28 
 
☒ 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. Joseph Calabrese, Professor of Psychiatry from the CWRU School of 
Medicine,  
Joseph.calabrese@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 caregiver emotional distress that required intervention by data collector 
or interventionist as well as those requiring referral and follow-up and instances where 
caregivers withdrew from the study.  
 
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. 
 

Page  26 of 28 
 
The SMC will review 1) all causes of mortality (e.g., caregiver 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  
 
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 caregiver distress and breach of 
confidentiality (as described above). Caregiver 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 
 

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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:  
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) 
 

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☐ 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.  
 
References  
 
Please reference the Investigator Manual for local institutional 
requirements.