Connect for Caregivers

Sponsor
University of Rochester (Other)
Overall Status
Completed
CT.gov ID
NCT04919070
Collaborator
National Institute on Aging (NIA) (NIH)
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Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Connect for Caregivers
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
5 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
'Connect for Caregivers' - Developing a Brief Intervention for Social Connectedness
Actual Study Start Date :
Jun 28, 2021
Actual Primary Completion Date :
Aug 27, 2021
Actual Study Completion Date :
Aug 27, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Perceived Autonomy Support [two weeks]

    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.

  2. Perceived Competence Scale [two weeks]

    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.

Secondary Outcome Measures

  1. Knowledge of Social Engagement [two weeks]

    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.

  2. Loneliness [two weeks]

    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. However, some individual items must be reverse-coded so that higher total scores reflect greater loneliness (i.e., 1=4, 2=3, 3=2, 4=1). These items (e.g., "How often do you feel there are people you can turn to?") are items 1,5,6,9,10,15,16,19,20. Total scores range from 20 to 80, with higher scores representing a worse outcome (i.e., greater loneliness).

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Rochester Rochester New York United States 14618
2 University of Rochester Rochester New York United States 14642

Sponsors and Collaborators

  • University of Rochester
  • National Institute on Aging (NIA)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sally Norton, Professor, University of Rochester
ClinicalTrials.gov Identifier:
NCT04919070
Other Study ID Numbers:
  • 00004316
  • P30AG064103
First Posted:
Jun 9, 2021
Last Update Posted:
Aug 31, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sally Norton, Professor, University of Rochester

Study Results

No Results Posted as of Aug 31, 2021