Tele-BA for Home-Delivered Meals Clients

Improving Social Connectedness in Home Delivered Meals Clients

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

Study Overview

• Status: Completed
• Conditions: Social Isolation
• Intervention / Treatment: Behavioral: Tele-Behavioral Activation; Behavioral: Tele-Friendly Visiting

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78712
      • University of Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tele-Behavioral Activation; 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; Five 1-hour sessions of BA delivered by a trained interventionist via video-conferencing
Active Comparator: Tele-Friendly Visiting; 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; Five 1-hour FV sessions delivered by a trained interventionist via video-conferencing

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).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptance of the Tele-BA intervention using a modified version of the Treatment Evaluation Inventory (TEI)	An 11-item self-report questionnaire used to measure intervention acceptability. For this project, reference to "Treatment" will be substituted with "Tele-BA." Items are rated using a 7-point Likert scale. Response values range 1-7 with different verbal anchors for each item. Total scores are calculated by summing responses to items 1-11; total scores range 11-77. The TEI consists of an 8-item General Acceptability subscale and a 3-item Negative Aspects (e.g., discomfort) subscale.	6-weeks follow-up (immediately post-intervention)
Change over time in social activities participation using the Social Engagement/Activities Questionnaire (SEAQ)	A 10-item self-report questionnaire used to measure homebound older adults' participation in a range of social-group activities, interpersonal interaction activities with family and friends, and solitary activities while taking account of their physical and functional health limitations and social circumstances under which they live. Items are rated using a Likert scale (6-point scale: 'not at all' = 0 to 'every day' = 5). Total scores are calculated by summing responses to items 1-10; total scores range 0-50.	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 coping strategies using the Brief COPE	A 16-item self-report questionnaire used to measure use of coping strategies for difficult situations. Items are rated using a Likert scale (4-point scale: 'not at all' = 0 to 'a lot' = 3). Total scores are calculated by summing responses to items 1-16; 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).

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: University of Texas at Austin
• Investigators: Principal Investigator: Martha L Bruce, PhD, MPH, Dartmouth-Hitchcock Medical Center

Publications and helpful links

General Publications

• Choi NG, Pepin R, Marti CN, Stevens CJ, Bruce ML. Improving Social Connectedness for Homebound Older Adults: Randomized Controlled Trial of Tele-Delivered Behavioral Activation Versus Tele-Delivered Friendly Visits. Am J Geriatr Psychiatry. 2020 Jul;28(7):698-708. doi: 10.1016/j.jagp.2020.02.008. Epub 2020 Mar 2.

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2017
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: October 15, 2019
• First Submitted That Met QC Criteria: October 16, 2019
• First Posted (Actual): October 18, 2019

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 5, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Behavioral Activation; Loneliness; Homebound
• Other Study ID Numbers: D19169

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: At this time there are no plans to share individual patient data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No