Social-LEAF Life Enhancing Activities for Caregivers

NCT05274074 | Completed Results DMC

• 2 other identifiers: 375254P30AG064103
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

This study examines a behavioral intervention to improve social connection and reduce loneliness for caregivers of a loved one with Dementia with Lewy Bodies (DLB).

Conditions

Social Connectedness

Outcome Measures

Primary Outcomes (1)

• Patient Reported Outcome Measurement Information System (PROMIS )Positive Affect

  Change in the Patient Reported Outcomes Measurement Information System (PROMIS)- Positive Affect from Baseline to Week 6. This is a 15-item scale measuring momentary positive affective experiences over the past 7 days. It is a five-point Likert-type scale (i.e.,"not at all, a little bit, somewhat, quite a bit, very much") resulting in 15-75 scale. Scores are summed to create a raw score. Individual items are positively skewed with 5 options from "Not at all" to "Very much." Higher scores indicate better positive affect and are a better outcome.

  Week 6

Secondary Outcomes (5)

• Berkman-Syme Social Network Index

  Week 6

• Patient Reported Outcome Measurement Information System (PROMIS) Social Isolation

  Week 6

• Patient Reported Outcome Measurement Information System (PROMIS) Satisfaction Role Activities

  Week 6

• Positive Aspects of Caregiving Scale

  Week 6

• University of California Los Angeles (UCLA) Loneliness Scale

  Week 6

Study Arms (2)

Wait-List Control

NO INTERVENTION

The wait-list control had a 6 week waiting period after which they received the Social LEAF intervention

Intervention

EXPERIMENTAL

Social LEAF is an adaptation of the Life Enhancing Activities for Family Caregivers program to focus on social relationships and loneliness.We utilized the Life Enhancing Activities or Caregivers (LEAF) intervention to display that social networks' can be used as a means of reinforcing the positive life skills of the intervention; and that these same skills will enhance social networks, increase mutual satisfaction in social interactions, and boost motivation to reach out to others, thus combatting social isolation. This group received the intervention for 6 weeks and we looked at maintenance 6 weeks after the end of the intervention.

Behavioral: Social LEAF

Interventions

Social LEAF BEHAVIORAL

Social LEAF is an adaptation of the Life Enhancing Activities for Family Caregivers program to focus on social relationships and loneliness. Social LEAF is a six-session group program provided by video-conference that teaches caregivers coping skills to improve social relationships and social connection. Social LEAF is delivered in groups of up to 10 caregivers via videoconference and will consist of six weekly hour-long discussion-based classes to teach positive coping skills around improving social relationships. Each week will focus on a skill from the original LEAF study adapted to the group and social context.

Intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be a primary care partner of a person that has been clinically diagnosed with Dementia with Lewy Bodies (DLB) or Parkinson's Disease Dementia, and has access to high-speed internet connection at home or in a location where they can speak privately with a facilitator. iPads and a hotspot will be given to those who lack internet and a sufficient mobile device but show willingness to participate. The iPads and hotspot will be returned to the study team once study procedures have concluded. Must be willing and ready to begin the intervention either immediately or in 6 weeks depending on which group they are randomly selected to be in.
• Must begin LEAF procedures as soon as consented to the study. Has not taken part in Aim 1 of the study.
• Will have waited the 6-week period before starting LEAF procedures after consenting and has not taken part in Aim 1 of the study.

You may not qualify if:

• Not a primary care partner of a person with DLB. Is a primary care partner of someone who has not been clinically diagnosed with DLB. Cannot speak English or provide clear and concise consent to the project.
• Has not started LEAF procedures at the beginning and has taken part in Aim 1 of the study.
• Has started/taken part in the LEAF procedures at the beginning and also has taken part in Aim 1 of the study.

Sponsors & Collaborators

• University of Rochester: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Limitations and Caveats

This is a small pilot trial. The intent was primarily to assess feasibility.

Results Point of Contact

• Title: Dr. Benzi M. Kluger
• Organization: University of Rochester

benzi_kluger@urmc.rochester.edu

5852754259

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: March 10, 2022
• Study Start: July 28, 2022
• Primary Completion: July 23, 2023
• Study Completion: July 23, 2023
• Last Updated: March 3, 2025
• Results First Posted: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After publication of main manuscript
• Access Criteria: Requesting investigators will need to provide a rationale for their request and plan for results. Depending on request, a Data User Agreement may also be required.

Locations

US (1)