Tele-BA for Home-Delivered Meals Clients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study to evaluate aging-service integrated, video-conference-based approaches to improve homebound seniors' social engagement and activities.

Official Title
-----------------
Improving Social Connectedness in Home Delivered Meals Clients

Conditions
-----------------
Social Isolation

Intervention / Treatment
-----------------
* Behavioral: Tele-Behavioral Activation
* Behavioral: Tele-Friendly Visiting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English speaking Clients of the Meals on Weals program ≥60 years old Score between 6-9 on the Hughes three-item version of the UCLA Loneliness Scale Exclusion Criteria: Dementia, as indicated by a score > 3 on the Six Item Screen Clinically significant depression, as indicated by a score ≥15 on the Patient Health Questionnaire (PHQ-9) Active suicide risk, as indicated by a positive response on any item of the Columbia Suicide Severity Rating Scale (C-SSRS) Uncorrectable hearing or vision impairment

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tele-Behavioral Activation<br>Manualized Behavioral Activation (BA) protocol delivered via videoconferencing by a trained BA interventionist; 5 sessions over 5 weeks, up to 1-hour in length. The interventionist guides participants in learning BA skills, focusing on strategies to decrease barriers to social connectedness (e.g., limited mobility, inadequate caregiving resources). | Behavioral: Tele-Behavioral Activation<br>* Five 1-hour sessions of BA delivered by a trained interventionist via video-conferencing<br>|
| Active Comparator: Tele-Friendly Visiting<br>Friendly Visitor (FV) calls delivered via videoconferencing by a trained FV interventionist; 5 sessions over 5 weeks, up to 1-hour in length. The interventionist provides social support to participants through good listening and provision of genuine regard. | Behavioral: Tele-Friendly Visiting<br>* Five 1-hour FV sessions delivered by a trained interventionist via video-conferencing<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change over time in social support measured using the Duke Social Support Index (DSSI) | A 10-item self-report questionnaire used to measure an individual's satisfaction with social support using a Likert scale (3-point scale, where anchor labels are specified for each item). This scale consists of two subscales: 4-item social interaction (objective support) scale and 6-item satisfaction with social support (subjective support) subscale. Total scores are calculated by summing responses to items across all items; total scores range 10-30. | Baseline, 6-week follow-up (immediately post-intervention), 12-week follow up (12 weeks post-intervention), 12-month follow-up (12-months post-intervention). | 
| Change over time in perceived social isolation measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Social Isolation Scale | An 8-item self-report questionnaire used to measure perceived social isolation using a Likert scale (5-point scale: 'never' = 1 to 'always' = 5). Total raw scores range from 8-40; raw scores are converted to T-scores using an appendix (T-scores are standardized scores that have a mean of 50 and SD of 10). Higher T-score values represent greater perceived social isolation. | Baseline, 6-week follow-up (immediately post-intervention), 12-week follow up (12 weeks post-intervention), 12-month follow-up (12-months post-intervention). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change over time in depression symptomatology measured using the Patient Health Questionnaire-9 (PHQ-9) | A 9-item self-report questionnaire used to measure symptoms of depression. Items are rated using a Likert scale (4-point scale: 'not at all' = 0 to 'nearly every day' = 3). Total scores are calculated by summing responses to items 1-9; total scores range 0-27. | Baseline, 6-week follow-up (immediately post-intervention), 12-week follow up (12 weeks post-intervention), 12-month follow-up (12-months post-intervention). | 
| Change over time in functional disability measured using the World Health Organization Disability Assessment Schedule (WHODAS 2.0) | A 12-item self-report questionnaire used to assess functioning in six domains of life: Domain 1: Cognition - understanding and communicating Domain 2: Mobility - moving and getting around Domain 3: Self-care - attending to one's hygiene, dressing, eating and staying alone Domain 4: Getting along - interacting with other people Domain 5: Life activities - domestic responsibilities, leisure, work and school Domain 6: Participation - joining in community activities, participating in society. Items are rated using a Likert scale (5-point scale: 'none' = 0 to 'Extreme/cannot do' = 4). Total scores are calculated by summing responses to items 1-12; total scores range 0-48. | Baseline, 6-week follow-up (immediately post-intervention), 12-week follow up (12 weeks post-intervention), 12-month follow-up (12-months post-intervention). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Loneliness, Homebound, Behavioral Activation