Back to resultsEngage Coaching for Latinos
Primary Purpose
Social Isolation, Loneliness, Caregiver Burnout
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Engage coaching
Sponsored by
About this trial
This is an interventional treatment trial for Social Isolation
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 40 yrs;
- Hispanic/Latino
- English or Spanish speaking;
- Caregiver for a community-dwelling family member with ADRD, living with (or in close proximity to) family member with dementia;
- Endorse elevated caregiving distress as measured by a score of ≥ 11 on the 10-item Perceived Stress Scale (PSS-10) and/or a score of 5 or greater on the Modified Caregiver Strain Index (MCSI);
- Endorse clinically significant loneliness as measured by a score of ≥ 6 on the UCLA Loneliness Scale: Short Form.
- Has access to e-mail in order to complete the e-consent module in REDCap which will be used in this study.
Exclusion Criteria:
- Primary language is not English or Spanish;
- Recent or current psychosis;
- Significant cognitive impairment on a cognitive screening measure at the HARP screening assessment;
- Hearing problems that preclude completion of the intervention.
Sites / Locations
- University of Rochester Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Engage Coaching
Arm Description
Engage Coaching helps caregivers bolster motivation for increasing connectedness, teaches problem solving skills, and provides behavioral practice with social engagement. Up to 8 brief sessions (typically 30 minutes) are provided weekly over no more than three months.
Outcomes
Primary Outcome Measures
Change From Baseline in Loneliness at Post Intervention
The UCLA Loneliness Scale Version 3 will be used to assess self-reported loneliness. 20 items, rated as to how often the participant has felt a certain way in the prior month (e.g., "How often do you feel alone?") -- "never" (1), "rarely" (2), "sometimes" (3), or "often" (4). Higher scores indicate greater loneliness. However, some individual items must be reverse-coded so that higher total scores reflect greater loneliness (i.e., 1=4, 2=3, 3=2, 4=1). These items (e.g., "How often do you feel there are people you can turn to?") are items 1,5,6,9,10,15,16,19,20. Total scores range from 20 to 80, with higher scores representing a worse outcome (i.e., greater loneliness). Mean change in total scores (change = baseline intervention scores - post scores) will be reported.
Secondary Outcome Measures
Change From Baseline in Social Functioning at Post Intervention
Satisfaction with Social Roles and Activities (PROMIS) is a computerized adaptive test (CAT). It produces T scores with a mean of 50 and standard deviation of 10. Greater scores indicate better outcomes (i.e., greater satisfaction with social role and activities). Mean change in T scores (change = post intervention scores - baseline scores) will be reported.
Change From Baseline in Quality of Life: Social Relationships at Post Intervention
The World Health Organization Quality-of-Life Scale: Brief Version (WHOQOL-BREF) is a 36-item measure of several domains (physical health, psychological health, social relationships, environment) of health related quality of life. Higher scores denote higher quality of life. Items are scored on a 1-5 Likert scale. The measure is calculated by summing the point values for the questions corresponding to each domain and then transforming the scores to a 0-100 point interval for each domain. Mean change in Domain 3 (social relationships) scores (change = post intervention scores - baseline scores) will be reported.
Full Information
NCT ID
NCT04875065
First Posted
April 30, 2021
Last Updated
April 13, 2023
Sponsor
University of Rochester
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT04875065
Brief Title
Engage Coaching for Latinos
Official Title
Healthy Aging Research Program (HARP): Engage Coaching Project for Latinos
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 24, 2021 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study asks: "what behavioral strategies are needed to help socially disconnected Hispanic/Latino caregivers with significant barriers to increasing connectedness?" This study uses a mixed methods approach to adapt a brief behavioral intervention-Social Engage psychotherapy-for use with socially disconnected Hispanic/Latino caregivers. This study is a single-arm clinical trial of Social Engage psychotherapy. We propose to enroll 10 participants for up to 8 weekly individual Social Engage psychotherapy sessions, over up to 3 months. Subjects will be aged 40 and older, and be caregivers for a community-dwelling family member with ADRD, living with (or in close proximity to) the family member with dementia, experiencing elevated caregiving distress and social disconnectedness.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Isolation, Loneliness, Caregiver Burnout
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Engage Coaching
Arm Type
Experimental
Arm Description
Engage Coaching helps caregivers bolster motivation for increasing connectedness, teaches problem solving skills, and provides behavioral practice with social engagement. Up to 8 brief sessions (typically 30 minutes) are provided weekly over no more than three months.
Intervention Type
Behavioral
Intervention Name(s)
Engage coaching
Intervention Description
Participants will complete up to 8 weekly individual Social Engage psychotherapy sessions. Participants will be allotted up to 3 months to complete all sessions, a time-frame that allows for two weeks without meeting to address life stressors such as illnesses that may pop up. All sessions are provided via phone or videocall (Zoom). The first and last session are longer - up to 60 minutes if needed. Middle sessions are shorter (20-45 minutes). Engage is a stepped care psychotherapy in that the simplest strategy is taught first-action planning (a derivative of problem solving therapy)-and "barrier strategies" are added only if needed. Action plans are designed to address loneliness and social isolation in the context of caregiving demands.
Primary Outcome Measure Information:
Title
Change From Baseline in Loneliness at Post Intervention
Description
The UCLA Loneliness Scale Version 3 will be used to assess self-reported loneliness. 20 items, rated as to how often the participant has felt a certain way in the prior month (e.g., "How often do you feel alone?") -- "never" (1), "rarely" (2), "sometimes" (3), or "often" (4). Higher scores indicate greater loneliness. However, some individual items must be reverse-coded so that higher total scores reflect greater loneliness (i.e., 1=4, 2=3, 3=2, 4=1). These items (e.g., "How often do you feel there are people you can turn to?") are items 1,5,6,9,10,15,16,19,20. Total scores range from 20 to 80, with higher scores representing a worse outcome (i.e., greater loneliness). Mean change in total scores (change = baseline intervention scores - post scores) will be reported.
Time Frame
Baseline and 3 months
Secondary Outcome Measure Information:
Title
Change From Baseline in Social Functioning at Post Intervention
Description
Satisfaction with Social Roles and Activities (PROMIS) is a computerized adaptive test (CAT). It produces T scores with a mean of 50 and standard deviation of 10. Greater scores indicate better outcomes (i.e., greater satisfaction with social role and activities). Mean change in T scores (change = post intervention scores - baseline scores) will be reported.
Time Frame
Baseline and 3 months
Title
Change From Baseline in Quality of Life: Social Relationships at Post Intervention
Description
The World Health Organization Quality-of-Life Scale: Brief Version (WHOQOL-BREF) is a 36-item measure of several domains (physical health, psychological health, social relationships, environment) of health related quality of life. Higher scores denote higher quality of life. Items are scored on a 1-5 Likert scale. The measure is calculated by summing the point values for the questions corresponding to each domain and then transforming the scores to a 0-100 point interval for each domain. Mean change in Domain 3 (social relationships) scores (change = post intervention scores - baseline scores) will be reported.
Time Frame
Baseline and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 40 yrs;
Hispanic/Latino
English or Spanish speaking;
Caregiver for a community-dwelling family member with ADRD, living with (or in close proximity to) family member with dementia;
Endorse elevated caregiving distress as measured by a score of ≥ 11 on the 10-item Perceived Stress Scale (PSS-10) and/or a score of 5 or greater on the Modified Caregiver Strain Index (MCSI);
Endorse clinically significant loneliness as measured by a score of ≥ 6 on the UCLA Loneliness Scale: Short Form.
Has access to e-mail in order to complete the e-consent module in REDCap which will be used in this study.
Exclusion Criteria:
Primary language is not English or Spanish;
Recent or current psychosis;
Significant cognitive impairment on a cognitive screening measure at the HARP screening assessment;
Hearing problems that preclude completion of the intervention.
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Engage Coaching for Latinos
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