Social-Life Enhancing Activities for Caregivers

Social Connectedness Clinical Trial

Official title:

Improving Care Partner Outcomes Through Positive Connections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05274074
• Other study ID #: 375254
• Secondary ID: P30AG064103
• Status: Completed
• Phase: N/A
• Start date: July 28, 2022
• Est. completion date: July 23, 2023

Study information

• Verified date: November 2023
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: July 23, 2023
• Est. primary completion date: July 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Social Connectedness

Intervention

Behavioral:
• Social LEAF
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.

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Loneliness (UCLA Loneliness Scale)	The UCLA Loneliness scale produces a continuous score of the degree to which participants endorse loneliness, which higher scores indicating greater loneliness.	Week 6
Primary	Loneliness (UCLA Loneliness Scale)	The UCLA Loneliness scale produces a continuous score of the degree to which participants endorse loneliness, which higher scores indicating greater loneliness.	Week 12
Secondary	Positive emotions (Modified Differential Emotions Scale)	The Modified Differential Emotions Scale, positive emotions subscale, assesses the frequency of experiencing positive emotions over the past week, with higher scores indicating greater frequency of positive emotions in the past week (range 1-4).	Week 6
Secondary	Positive emotions (Modified Differential Emotions Scale)	The Modified Differential Emotions Scale, positive emotions subscale, assesses the frequency of experiencing positive emotions over the past week, with higher scores indicating greater frequency of positive emotions in the past week (range 1-4).	Week 12
Secondary	Positive aspects of caregiving (Positive Aspects of Caregiving scale)	The Positive Aspects of Caregiving Scale consists of nine items assessing positive consequences of caregiving, each rated on a 1-5 Likert scale (range of scores 9-45), with a higher score reflects a more positive perception of the caregiving experience.	Week 6
Secondary	Positive aspects of caregiving (Positive Aspects of Caregiving scale)	The Positive Aspects of Caregiving Scale consists of nine items assessing positive consequences of caregiving, each rated on a 1-5 Likert scale (range of scores 9-45), with a higher score reflects a more positive perception of the caregiving experience.	Week 12
Secondary	Social engagement (Social Engagement and Activities Questionnaire; SEAQ)	The SEAQ measures the frequency during the past month of ten social activities, and yields a total score ranging from 0 (no engagement in any of the ten activities) to 50 (daily engagement in all ten activities).	Week 6
Secondary	Social engagement (Social Engagement and Activities Questionnaire; SEAQ)	The SEAQ measures the frequency during the past month of ten social activities, and yields a total score ranging from 0 (no engagement in any of the ten activities) to 50 (daily engagement in all ten activities).	Week 12