Connect for Caregivers

'Connect for Caregivers' - Developing a Brief Intervention for Social Connectedness

Connect for Caregivers is a intervention feasibility pilot study. The purpose of the study is to pilot test a newly developed single session behavioral intervention to help caregivers of individuals with Alzheimer's Disease or related dementias gain understanding of the importance of increasing social connectedness, awareness of their personal barriers to connectedness, and knowledge of local resources for promoting connectedness.

Study Overview

• Status: Completed
• Conditions: Loneliness; Social Isolation
• Intervention / Treatment: Behavioral: Connect for Caregivers

Detailed Description

Connect for Caregivers is a intervention feasibility pilot study. We use a mixed methods approach to initiate the development and testing process for a single session behavioral intervention to help caregivers gain understanding of the importance of increasing connectedness, awareness of their personal barriers to connectedness, and knowledge of local resources for promoting connectedness. The intervention-"Connect 4 Caregivers"-has three components: 1) psychoeducational materials on the importance of connectedness for health and wellbeing; 2) a card sort-based 'discussion prioritization tool' that systematizes and routinizes the process of identifying and prioritizing barriers to connectedness; 3) personalized resources to address the identified barriers/targets.

Aim 1 is to investigate whether Connect for Caregivers is associated with a signal for efficacy for changing connectedness by having n=5 caregivers complete the single session intervention and provide quantitative and qualitative data on their experience with the intervention and motivation to work on increasing their social connectedness (a signal for potential efficacy).

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester
    • Rochester, New York, United States, 14618
      • University of Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ≥ 50 yrs;
2. English speaking;
3. Caregiver (age 50 or older) for a community-dwelling family member with ADRD, living with (or in close proximity to) family member with dementia;
4. 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).
5. Social connectedness: UCLA Loneliness Scale: Short Form score of >5.

Exclusion Criteria:

1. Primary language is not English;
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
5. Hearing problems that preclude completion of the intervention.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Connect for Caregivers; Connect for Caregivers is a single session behavioral intervention with three components: 1) psychoeducation on the importance of connectedness for health and well-being; a card sort-based discussion prioritization tool that systematizes and routinizes the process of identifying and prioritizing barriers to connectedness; 3) personalized resources to address the identified barriers and targets.

Behavioral: Connect for Caregivers; The intervention being studied is a single session guided behavioral intervention to improve social connectedness in caregivers of individuals with ADRD. The intervention, Connect for Caregivers, provides psychoeducation on the importance of social connectedness for health and well-being, includes a card-sort process to identify and prioritize barriers to connectedness, and provides personalized resources and strategies for caregivers to use to increase their social connectedness.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Autonomy	This is a self-report measure that assesses a mechanism posited by Self-Determination Theory to increase motivation for healthy behaviors. It has 6 items, a range from 6-30, and higher scores indicate greater perceived autonomy.	two weeks
Perceived Competence Scale	This is a self-report measure that assesses a mechanism posited by Self-Determination Theory to increase motivation for healthy behaviors. It has 7 items, a range from 7-35, and higher scores indicate greater perceived competence.	two weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge of Social Engagement	This is a self-report measure that assesses a subject's knowledge of the importance of social connections. It has 4 items, a range from 4-20, and higher scores indicate greater knowledge.	two weeks
Loneliness	UCLA Loneliness Scale Version 3, which assesses self-reported loneliness. 20 items, rated as to how often the participant has felt a certain way in the prior month (e.g., "How often do you feel alone?") -- "never" (1), "rarely" (2), "sometimes" (3), or "often" (4). Higher scores indicate greater loneliness. Total scores range from 20 to 80, with higher scores representing a worse outcome (i.e., greater loneliness).	two weeks

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: National Institute on Aging (NIA)

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2021
• Primary Completion (Actual): August 27, 2021
• Study Completion (Actual): August 27, 2021

Study Registration Dates

• First Submitted: June 2, 2021
• First Submitted That Met QC Criteria: June 2, 2021
• First Posted (Actual): June 9, 2021

Study Record Updates

• Last Update Posted (Actual): December 29, 2022
• Last Update Submitted That Met QC Criteria: December 8, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Social Connectedness
• Other Study ID Numbers: 00004316; P30AG064103 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The final dataset will include self-reported demographic data from interviews with 5 older adults who are caregivers for individuals with ADRD. Data from this research will be made available to the public in the University of Rochester's institutional repository, UR Research, at https://urresearch.rochester.edu. We will share the research protocols, in a text format, such as MS Word or PDF. For quantitative data, the PI will make available the actual datasets generated from research, in a commonly- used format such as a SAS® dataset. The datasets will be associated with a related publication, research protocol or other documentation of the original research.
• IPD Sharing Time Frame: Timetable to release the data: the data and referenced resources from publications will be made available by the on-line publication date.
• IPD Sharing Access Criteria: The investigators will make the data and associated documentation available to users only under a data-sharing agreement as suggested by the NIH that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. 4. De-identification of data from human subjects: A final complete database will be created to host all data which will be stripped of any identifiers and stored pursuant to UR Institutional Review Board protocols.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No