'Connect for Caregivers' - Developing a Brief Intervention for Social Connectedness
Phase: NA
Conditions: Social Isolation, Loneliness
Sponsor: University of Rochester

5-20-2021 
 
Official Title: ‘Connect for Caregivers’ – Developing a Brief Intervention 
for Social Connectedness 
 
NCT number: NCT04919070 
 
Document Approval Date: 05/20/21 
 
Document Date:  uploaded 12/8/22 
 
Document Type: Study Protocol and Statistical Analysis Plan  
 
 

5-20-2021 
 
Study Protocol 
‘Connect for Caregivers’ – Developing a Brief Intervention for Social Connectedness 
Principal Investigator –Sally Norton 
  
A Pilot Study for Year One of the  
Rochester Roybal Center for Social Ties and Aging Research (P30AG064103)   
Co-Investigators: Kim Van Orden, PhD, Marsha Wittink PhD, MD 
 
 
 
1. PURPOSE OF STUDY  
  
Connect for Caregivers is a mixed method intervention development pilot study. The 
purpose of the study is to develop and pilot test a single session behavioral intervention 
to help caregivers gain understanding of the importance of increasing social 
connectedness, awareness of their personal barriers to connectedness, and knowledge 
of local resources for promoting connectedness. The specific aims of this mixed method 
study are:  
Aim 1 To characterize caregivers' understanding of their experiences of social 
connectedness and of their perceptions of barriers to social connectedness, 
including which barriers are most common, most problematic, and most difficult 
to change.  
Aim 2 To use information provided by caregivers (in Aim 1) to develop a card 
sort discussion prioritization tool (Connect for Caregivers) that will systematize 
and routinize a process whereby caregivers and interventionists can 
collaboratively identify and prioritize personalized intervention targets for 
promoting connectedness.  
Aim 3 To investigate whether Connect for Caregivers (a card sort discussion 
prioritization tool combined with personalized education and resources) is 
associated with a signal for efficacy for changing connectedness. 
 
  
This submission is for conducting Aim SA3, the final phase of the study, as approved in 
the original study Protocol. 
 
  
 
2. BACKGROUND AND RATIONALE  
Older caregivers for family members with Alzheimer’s disease or related dementia 
(ADRD) are at risk for social disconnectedness that impacts health and quality of life. 
Social connectedness represents an untapped intervention target to improve caregiver 
well-being and health. Caregivers who report high social connectedness appear to be 
buffered from high caregiving burden because they perceive more positive aspects of 
caregiving. Barriers to connectedness among caregivers are numerous, varied, and 
dynamic. Current caregiver interventions effectively improve outcomes for the family 

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member with dementia and reduce caregiver burden, but do not improve 
connectedness for the caregiver. Other interventions (e.g., caregiver support groups) 
have not been tested with regards to connectedness.  The evidence base for strategies 
to promote connectedness is extremely limited. Promising interventions are 
multifaceted, intensive, and/or involve significant time out of the home, rendering them 
infeasible for most caregivers. There are no evidence-based interventions for promoting 
connectedness in older caregivers for individuals with ADRD. 
 
3. ADMINISTRATION ORGANIZATION 
Caregiver interviews will be conducted in the subject’s home or convenient location 
identified by the subject. Due to the COVID-19 pandemic, part SA2 will be conducted by 
ZOOM and since we will use video and audio, caregiver subjects will need to have a 
stable internet connection to participate. The focus group will be conducted via ZOOM. 
 
4. STUDY DESIGN 
  
This is a mixed method intervention development study using semi structured interviews 
(SA 1a and 2) and a focus group (SA 1b) to develop and refine a psycho-behavioral 
intervention that we will then pilot test (SA 3) using a non-randomized single arm pre-
post approach.    
  
Study outcomes/endpoints 
Aim 3: To investigate whether Connect for Caregivers—a card sort discussion 
prioritization tool combined with personalized education and resources—is associated 
with a signal for efficacy for changing connectedness. We will be conducting AIM SA3 in 
this phase of the study, as approved in the original study Protocol. 
•        Outcome 3a: A non-random sample of caregivers (n=5) will complete the 
Connect for Caregivers tool with a research assessor, including discussing 
psychoeducational materials on the benefits of social connectedness, completing the 
card sort to identify personal barriers to connectedness, and reviewing personalized 
community resources to address those barriers. Using semi-structured interviews, they 
will provide feedback on the experience of the intervention, including ease of completing 
it and potential utility as well as the extent to which they experienced the SDT 
mechanisms of: autonomy, competence, and relatedness while completing the tool and 
after completing it. 
•        Outcome 3b: Participants will also complete quantitative measures of their 
motivation to increase social connectedness via self-report measures that assess 
mechanisms posited by Self-Determination Theory (i.e., autonomy, competence, 
relatedness). Participants will complete these measures at their initial screening 
interview and again after completing the Connect for Caregiver intervention. 
 
5. SUBJECT POPULATION 
We will enroll approximately 5 subjects, who are caregivers (age 50 or older) for a 
community-dwelling family member with ADRD, living with (or in close proximity to) the 
family member with dementia.  Caregivers will be recruited from the IRB approved 

5-20-2021 
Health Aging Research Program (HARP) Population Study (RSRB00068059) (see III-d 
Recruitment Procedures).  Care managers will be recruited from Lifespan of Rochester. 
 
Gender, Age, Racial, and Ethnic Origin of Subjects:  
Caregivers in the US are more likely to be women (67%); Caregivers are also more 
likely to be white, non-Hispanic (67%), while 10% are African American and 8% are 
Hispanic. Using the 2018 Alzheimer’s Disease Facts and Figures along with our local 
demographic distributions, we plan to target 25% minority and 67% women enrollment. 
We will proactively recruit minority participants (including targeting men for enrollment, 
as they represent the gender minority in the caregiver population) using best practices 
for minority recruitment, including working with providers serving minorities; 
collaborating with community gatekeepers; tailoring the recruitment materials to the 
culture and education level in inner city populations.    
 
Procedures for assignment to a study group: Specific Aims 1 and 2 are descriptive.   For 
Aim 3, all subjects will receive the intervention. Aim 3 is a single-arm pilot of the newly 
developed intervention, Connect for Caregivers.  For Aim SA3, the originally approved 
N of 5 subjects will be enrolled. No additional subjects will be enrolled. 
 
6. INCLUSION AND EXCLUSION CRITERIA 
Caregiver Inclusion criteria (assessed at the HARP Population Study 
RSRB00068059, screening assessment): 
1) Caregiver (age 50 or older) for a community-dwelling family member with ADRD, 
living with (or in close proximity to) family member with dementia.  
2) Elevated caregiving distress: Above population mean (>11) on 10-item Perceived 
Stress Scale (PSS-10) and/or at least moderate caregiver strain (score >= 5) on the 
Modified Caregiver Strain Index (MCSI).  
3) Social connectedness: UCLA Loneliness Scale: Short Form score of equal to or 
greater than 6 (n=10;  Short Form score of 3-5,  n=10).  
4) Able to provide informed consent to participate in the research study. 
5) For phase SA2, a stable internet connection for using Zoom video and audio. 
 
Caregiver Exclusion criteria (assessed at the HARP screening assessment):  
1) Non English speakers because our primary community partner agency (Lifespan) 
cannot currently accommodate non-English speaking clients.  
2) Current problem drinking on the AUDIT-C (score of 5 or greater indicating exclusion).  
3) Current non-alcohol psychoactive substance abuse (MINI Neuropsychiatric 
Interview), psychotic disorders (current and lifetime, MINI), bipolar disorder (MINI), and 
current mood disorder with psychotic features (MINI).  
4) Significant cognitive impairment (MOCA <22) and those with hearing problems that 
preclude completion of interviews will be excluded. 
 
Vulnerable Subjects: Individuals who are 50 years of age and older with social risk 
factors for poor mental and physical health outcomes will be included. The results of this 
study will inform future research and clinical interventions aimed at improving mental 
health treatment for older caregivers. 

5-20-2021 
 
7. RECRUITMENT METHODS 
Caregiver subjects will be recruited via the IRB approved HARP Population Study 
(RSRB00068059), a research registry run by the current study’s Investigators. In 
compliance with procedures of the Population Study protocol, subjects of the Population 
Study consent to allow HARP Population Study researchers to share subjects’ 
identifiable data (both name and contact information) with investigators conducting 
HARP research at the University of Rochester; in addition, they consent to allow their 
data collected as part of the Population Study to be included in their research record for 
subsequent HARP studies they participate in, including the current study. All eligible 
participants will be provided with a study brochure, at their in-person screening visit and 
given information about the study. 
 
8. CONSENT PROCESS 
Caregiver Consent: Eligible subjects who have agreed to have their contact 
information shared will be contacted by the project coordinator and then scheduled for 
their semi-structured interview. We are requesting a waiver of documentation of consent 
for the caregivers because the research is no greater than minimal risk and the semi-
structured interview questions will be addressing a topic where written consent is not 
normally required. The waiver won’t affect the rights and welfare of the subjects. Eligible 
subjects will have an opportunity to review the information letter with the interviewer and 
ask questions and have their questions answered to their satisfaction prior to the start of 
their semi-structured interview. The process of reviewing the information letter will be 
conducted in a manner to facilitate questions from potential study subjects. If a study 
team member is unable to answer a question, an investigator will be contacted. All 
questions from potential subjects should be answered prior to the interviewer initiating 
the semi-structured interview. All subjects will receive a copy of the study information 
letter. No subjects will be involved in research activities unless an investigator or a 
designated study staff member has completed a thorough review of the information 
letter with the subject.  
 
The information that is given to the subject shall be in language understandable to the 
subject. Potential study subjects will be given ample time to read and consider the 
information letter. All subjects will be reminded of the voluntary nature of study 
participation. Research personnel will explain the study, the voluntary nature of 
participation, the study’s potential benefits and risks, and alternatives. An explanation of 
risks will include information that questions asked may cause subjects to feel 
uncomfortable or upset. They will be informed that they may withdraw from the study at 
any time for any reason without negative consequences and receive full reimbursement 
for the study. Consent will be obtained during Aim SA3 in the same manner as was 
done under previously approved Aims SA1 and SA2. We are requesting a waiver of 
documentation of consent for caregivers who enroll in SA3 because the research is no 
greater than minimal risk and the interview questions will be addressing a topic where 
written consent is not normally required. The waiver won’t affect the rights and welfare 
of the subjects. 
 

5-20-2021 
  
 
9. STUDY PROCEDURES 
Caregiver Subjects:  The card sort intervention will be conducted by a trained research 
assistant (RA). The intervention will be conducted via ZOOM, audio-recorded, and 
typically last between 45-60 minutes. Interview questions will focus on (1) how 
participants characterize social connectedness and activities they use to connect, (2) 
social connections that are important/meaningful to them, (3) what makes social 
connections easier and more difficult (including barriers), (4) how their social 
connections may have changed with the caregiver role, (5) how or whether they 
prioritize social connectedness in their day to day lives, and (6) the advice they would 
give to new caregivers about maintaining or improving social connections. We will use a 
laddered technique with early questions designed to be minimally intrusive and 
deliberately broad to allow participants to focus on the experiences of social connection 
important to them. Later questions will be built off the earlier questions and probe for 
detail and specific examples of participants’ unique experiences with social 
connectedness. The semi-structured interviews will be audio recorded so that the full 
conversation can be transcribed for later analysis, and subjects will be informed of this 
before discussion begins. No identifying information (for example, subject names, or 
other details shared during the discussion) will be included in the transcript. The audio 
recording will be transferred from the recording device to a secure computer in the 
School of Nursing, after which the recording will be deleted from the recording device. 
The de-identified electronic version of the transcript will remain on the School of 
Nursing’s secure computer where it will be accessible only to the study PI and project 
team members. For Aim SA3, new measures will be used and are based on the work 
completed in AIMS SA1 and SA2.   
 
Caregiver subjects participating in SA3: Questions included in the last few slides of 
the Power Point presentation of the card sort tool will be read to the participants, and 
individual semi structured interviews will also be conducted. The questions in the Power 
Point presentation of the card sort tool and the semi-structured interviews will be 
conducted by a research assistant (RA) trained in qualitative interviewing techniques. A 
second research assistant may also join the call for training purposes. Because the 
interviews will be recorded using Zoom video and audio, subjects will need to have a 
stable internet connection to participate.   
  
 
10. AUDIO/VIDEO RECORDINGS  
We will use audio recorders and Zoom which are HIPPA-compliant and URMC-
approved.  The audio files will be uploaded onto a secure database within the School of 
Nursing usually within 24 hours (occasionally interviews occurring off site on a Friday 
afternoon will be uploaded on Monday morning).  The audio recordings will be 
transcribed and the transcripts deidentified.  Audio recordings will then be used to verify 
the transcription accuracy.  Audio recordings will be archived with a unique identifier for 
linkage to the other data and will be kept for 3 years. It is occasionally helpful during 
data analysis to listen to the original audio recording to verify the intent of the speaker 

5-20-2021 
(e.g., para linguistic cues of humor, sarcasm, or emotion that are not contained in the 
transcription). The archived recordings will be housed on a University of Rochester 
School of Nursing firewalled, password-protected, and HIPAA compliant server and in 
BOX which is URMC-approved. Unique identifiers will be used to maintain future linkage 
between the archived conversations and the Analytic File.   
 
11.  RISKS TO SUBJECTS  
Potential risks to subjects: minimal risk for all procedures. 
For research assessments—self-report questionnaires and semi-structured interviews—
the primary risk is invasion of privacy, breach of confidentiality (if safety issues are 
detected), or mild reactions of distress or fatigue. All assessment measures and 
procedures have been safely used previous research with older adults; no sustained 
negative effects from assessments are expected, but negative outcomes cannot be 
ruled out. For Aim SA3, we will minimize potential risks to subjects by having the trained 
interventionists report to the PI any concerns that may arise during administration of any 
of the measures. 
 
Private identifiable information collection: Study coordinators and research team 
members will have access to individually identifiable private information about human 
subjects. 
 
For the intervention, Connect for Caregivers, the primary risk of is emotional distress 
or fatigue. Subjects may think about stressors, negative life events, and caregiving 
burden/distress; they will receive support from the interventionist for such experiences. 
No sustained negative effects are expected, but negative outcomes from behavioral 
interventions cannot be ruled out. The study PI (Dr. Norton) will provide weekly (and as 
needed) supervision. In addition, Dr. Van Orden (Co-I) is a clinical geropsychologist and 
is experienced in working with older adults, including those experiencing emotional 
distress and will available as needed. 
 
Regarding alternative interventions, subjects will not be prohibited from seeking out 
supportive social services, or mental health services (for ethical reasons). 
 
12.  POTENTIAL BENEFITS TO SUBJECTS 
Caregiver subjects might find identifying their own barriers and facilitators to social 
connection helpful. They may further benefit from feelings of altruism connected with 
participation in research designed to better understand the mental health needs and 
experiences of community-residing older adults. There are no other anticipated benefits. 
  
13.  COSTS FOR PARTICIPATION 
None anticipated.  The location of the caregiver interviews will be by ZOOM due to 
COVID-19 safety guidelines. The location for the care manager focus group will be via 
ZOOM.  
 
14. PAYMENT FOR PARTICIPATION  

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Each subject will be paid $20 by check for their participation in each of the three parts of 
SA3, for a maximum total of $60 per subject..  
 
15. SUBJECT WITHDRAWALS 
We do not anticipate any circumstances under which participants will be withdrawn by 
the investigator. Subjects are free to withdraw at any time without negative 
consequences. Subjects may also refuse to answer any individual questions.  
 
If a subject voluntarily withdraws from the study we will note the reason. We will use the 
data already collected unless the subject indicates they want the data destroyed. In the 
event of the latter, subjects who withdraw from the study will be replaced.  
  
 
16. PRIVACY AND CONFIDENTIALITY OF SUBJECTS AND RESEARCH DATA 
In order to protect the confidentiality of subject information, we will take a number of 
precautions. These include training research interviewers in confidentiality procedures; 
entry and storage of data using coded identification labels; maintenance of project 
computers in secure locations with restricted access by enforced password protection; 
use of HIPAA compliant data management software (REDCAP). Back-ups of all study 
files will be made daily to allow for recovery of data due to disk failure. All data, 
including assessment measures, will be obtained with the written consent of the subject. 
Information pertaining to individual subjects will be released with the subject’s informed 
and written consent only, except in unusual cases where withholding the information 
might pose a serious risk or danger to the subject or others. All data will be identified by 
a uniquely coded study number assigned to each subject. Access to the master list of 
study numbers will be restricted to Dr. Norton and the CRC. Confidentiality will be 
further maintained by the storage of "hard copy" data in locked files in a locked office. 
Access to computerized data is restricted and subject to review by Dr. Norton. 
Publications or presentations will report only cumulative data or descriptions certain to 
maintain participants' anonymity. All data collection involving human subjects will be 
HIPAA compliant. Audio recording devices will be kept on the person of the study 
interviewer who will return immediately to the School of Nursing with audio recorder 
after the interview has been completed. The audio recording will be immediately 
uploaded to the School of Nursing secure server, and once the upload is complete, the 
recording will immediately be deleted from the recording device. Since two recording 
devices are used to insure protection from any unexpected technical problems, both 
recording devices will have the recordings deleted as soon as uploads are complete 
after each interview. All data involving human subjects will be stripped of any identifiers; 
the data will be stored in a secure HIPAA compliant program called REDCAP, which 
manages protected health information in a HIPAA compliant manner. Audio recordings 
of semi-structured interviews will be transcribed and then kept for three years 
 
 
Risks associated with emotional distress or fatigue will be minimized by employment of 
research personnel with appropriate backgrounds and experience and work with 
psychological factors and elderly subjects. The baseline research interview will last 

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approximately two hours in total. Given the length of time involved for this assessment, 
and concerns regarding subject health and well-being, subjects will be reminded that if 
they become fatigued, they may terminate the interview at any time, and that the 
interview can be conducted over multiple sessions as needed. Research personnel will 
further be trained to recognize potential signs of fatigue among elderly subjects, and to 
actively suggest alternative data collection strategies (including telephone-based and 
mail-in interviews), in order to reduce the possibility of overwhelming study subjects and 
to ensure completeness of data collection. These strategies have been employed 
effectively in the PI and Co-I’s past research involving older adult populations.   
During the course of the semi-structured interviews, the researcher will monitor subjects' 
reactions for signs of distress or fatigue. If necessary, subjects may take breaks from 
the interview, or complete the interview over several sessions if fatigue becomes a 
concern.  
 
 
 
17. DATA / SAMPLE STORAGE FOR FUTURE USE 
Not applicable 
 
18. DATA AND SAFETY MONITORING PLAN 
Attached 
 
19. STATISTICAL ANALYSIS PLAN 
  
Testing the ‘Connect for Caregivers’ discussion prioritization tool: Aim 3 involves a pilot 
test of the Connect for Caregivers discussion prioritization tool with a sample of 
caregivers who report disconnectedness (n=5). Caregivers will receive the 
psychoeducation materials on connectedness (delivered by research staff), complete 
the card sort task to identify personal barriers to connectedness, and received 
personalized community resources to address their identified barriers to connectedness. 
Using the methodology described in Aim 1 for semi-structured interviews, caregivers will 
provide feedback on the experience of the intervention, including ease of completing it 
and potential utility. Participants will also complete quantitative measures of their 
motivation to increase social connectedness via self-report measures that were 
developed to test mechanisms posited by Self-Determination Theory that we have used 
with success in prior studies with social connectedness interventions (i.e., Perceived 
Competence Scale and Perceived Autonomy Scale).  Participants will complete these 
measures at their initial screening interview (as described in the STAR Core Battery 
above) and again after completing the Connect for Caregiver intervention. We will use 
descriptive statistics to compare changes in mean scores pre and post completion of 
the tool.