Engage Coaching for Latinos

Loneliness Clinical Trial

Official title:

Healthy Aging Research Program (HARP): Engage Coaching Project for Latinos

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04875065
• Other study ID #: STUDY00006126
• Secondary ID: P30AG064103
• Status: Completed
• Phase: N/A
• Start date: January 24, 2021
• Est. completion date: May 31, 2022

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

1. Age = 40 yrs;

2. Hispanic/Latino

3. English or Spanish speaking;

4. Caregiver for a community-dwelling family member with ADRD, living with (or in close proximity to) family member with dementia;

5. 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);

6. Endorse clinically significant loneliness as measured by a score of = 6 on the UCLA Loneliness Scale: Short Form.

7. Has access to e-mail in order to complete the e-consent module in REDCap which will be used in this study.

Exclusion Criteria:

1. Primary language is not English or Spanish;

2. Recent or current psychosis;

3. Significant cognitive impairment on a cognitive screening measure at the HARP screening assessment;

4. Hearing problems that preclude completion of the intervention.

Related Conditions & MeSH terms

• Caregiver Burden
• Caregiver Burnout
• Loneliness
• Social Isolation

Intervention

Behavioral:
• Engage coaching
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.

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	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	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.	Baseline and 3 months
Secondary	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.	Baseline and 3 months
Secondary	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.	Baseline and 3 months