Clinical trial NCT05274074: Social-LEAF Life Enhancing Activities for Caregivers
Official title: Improving Care Partner Outcomes Through Positive Connections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Connectedness
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-03-10
Enrollment: 58
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion criteria:

* 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.

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.

Primary outcomes:
measure: Patient Reported Outcome Measurement Information System (PROMIS )Positive Affect
timeFrame: Week 6
Secondary outcomes:
measure: Berkman-Syme Social Network Index
timeFrame: Week 6
measure: Patient Reported Outcome Measurement Information System (PROMIS) Social Isolation
timeFrame: Week 6
measure: Patient Reported Outcome Measurement Information System (PROMIS) Satisfaction Role Activities
timeFrame: Week 6
measure: Positive Aspects of Caregiving Scale
timeFrame: Week 6
measure: University of California Los Angeles (UCLA) Loneliness Scale
timeFrame: Week 6
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
References: