Improving Care Partner Outcomes Through Positive Connections
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Rochester
- Enrollment
- 58
- Locations
- 2
- Primary Endpoint
- Patient Reported Outcome Measurement Information System (PROMIS )Positive Affect
Study Overview
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).
Detailed Description
The objective of the Social-LEAF study is to examine psychological mechanisms whereby Social LEAF delivered in a group and via video call reduces loneliness and improves positive emotions for older caregivers of loved ones with DLB. This is an 18-month Stage 2 study examining Social LEAF, which is strengths-based and teaches positive coping skills focused on improving social relationships and is delivered remotely in a group format. These two adaptations to the original LEAF intervention are included to provide a more potent means of improving social connection. A pilot phase with up to 20 caregivers (Aim 1) will address these adaptations regarding feasibility, acceptability, and signal for reducing loneliness, with refinements as needed. A second phase (Aims 2 and 3) will involve a randomized trial comparing Social LEAF to control (30 caregivers in each arm) on loneliness (primary outcome), positive affect (mechanism), and social engagement (mechanism). Data will also be collected on acceptability and perceived benefits using mixed methods.
Aim 1 is to refine the LEAF intervention to target social relationships and loneliness.
Aim 2 is to examine feasibility and acceptability of Social LEAF for DLB caregivers.
Aim 3 is to examine efficacy of Social LEAF in reducing loneliness, increasing positive affect, and increasing social engagement.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Patient Reported Outcome Measurement Information System (PROMIS )Positive Affect
Time Frame: Week 6
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.
Secondary Outcomes
- 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)
Investigators
Benzi Kluger, MD
Professor
University of Rochester