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Completed

NCT Number: NCT05274074

Social-LEAF Life Enhancing Activities for Caregivers

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).

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Key information

Conditions

Social Connectedness

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester

Rochester, New York, 14642, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Berkman-Syme Social Network Index

    Time frame: Week 6

    Change in the Berkman-Syme Social Network Index from baseline to week 6. This scale is used to measure social isolation and loneliness and includes subjective experiences of connection to contacts. This measure is a questionnaire to assess the type, size, closeness, and frequency of contacts in a respondent's current social network. This index is the sum of four binary items (Married (no = 0; yes = 1); close friends and relatives (0-2 friends and 0-2 relatives = 0; all other scores = 1); group participation (no = 0; yes = 1); participation in religious meetings or services (less than or equal to every few months = 0; greater than or equal to once or twice a month = 1)). The total index range is 0-4 with a higher score indicative of better social network.

  2. Patient Reported Outcome Measurement Information System (PROMIS) Social Isolation

    Time frame: Week 6

    Change in the Patient Reported Outcome Measurement Information System (PROMIS)- Social Isolation from baseline to week 6. This scale assesses perceptions of being avoided, excluded, detached, disconnected from by others. The measure has a Likert Scale (1-5 with 1 being Never and 5 being Always). Raw scores were converted to a T-score, a standardized score with a mean of 50 and a standard deviation of 10. Lower scores indicate lesser social isolation and are therefore a better outcome.

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

    Time frame: Week 6

    Change in the PROMIS V 2.0 Satisfaction Role Activities from baseline to week 6. This scale assessed caregivers satisfaction level in their participation in relaxation and leisure activities.The measure has a Likert Scale (1-5 with 1 being Not at all and 5 being Very much). Raw scores were converted to a T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher satisfaction and are therefore a better outcome.

  4. Positive Aspects of Caregiving Scale

    Time frame: Week 6

    Change in the Positive Aspects of Caregiving Scale from baseline to week 6. This scale consists of nine items assessing positive consequences of caregiving, each rated on a 0-4 Likert scale (range of scores 0-36), where a higher score reflects a more positive perception of the caregiving experience.

  5. University of California Los Angeles (UCLA) Loneliness Scale

    Time frame: Week 6

    Change in the UCLA Loneliness scale from baseline to week 6. This scale produces a continuous score of the degree to which participants endorse loneliness. The measure has 20 items with a Likert scale of 1-4 with 1 being Never and 4 being Always resulting in a 20-80 scale. Lower scores indicate better outcome.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Improving Care Partner Outcomes Through Positive Connections

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 10, 2022
Registry last updated
Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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