Social-Life Enhancing Activities for Caregivers

University of Rochester

Status: Completed

Conditions: Social Connectedness

Treatments: Behavioral: Social LEAF

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05274074

P30AG064103 (U.S. NIH Grant/Contract)

375254

Details and patient eligibility

About

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). The intervention is called Social LEAF. The objective 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 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.

Enrollment: 61 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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:

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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61 participants in 2 patient groups

Aim 1

No Intervention group

Aim 2

Experimental group

Description:

We will be utilizing 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.

Treatment:

Behavioral: Social LEAF