Tele-BA for Home-Delivered Meals Clients

NCT04131790 | Completed

• 1 other identifier: D19169
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Social Isolation

Keywords

Loneliness; Homebound; Behavioral Activation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change over time in depression symptomatology measured using the Patient Health Questionnaire-9 (PHQ-9)

  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)

  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 Outcomes (3)

• Acceptance of the Tele-BA intervention using a modified version of the Treatment Evaluation Inventory (TEI)

  6-weeks follow-up (immediately post-intervention)

• Change over time in social activities participation using the Social Engagement/Activities Questionnaire (SEAQ)

  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

  Baseline, 6-week follow-up (immediately post-intervention), 12-week follow up (12 weeks post-intervention), 12-month follow-up (12-months post-intervention).

Study Arms (2)

Tele-Behavioral Activation

EXPERIMENTAL

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

Tele-Friendly Visiting

ACTIVE COMPARATOR

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

Interventions

Tele-Behavioral Activation BEHAVIORAL

Five 1-hour sessions of BA delivered by a trained interventionist via video-conferencing

Tele-Behavioral Activation

Tele-Friendly Visiting BEHAVIORAL

Five 1-hour FV sessions delivered by a trained interventionist via video-conferencing

Tele-Friendly Visiting

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• University of Texas at Austin: collaborator

Study Sites (1)

University of Texas

Austin, Texas, 78712, United States

Location

Related Publications (1)

• 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.

  PMID: 32238297 DERIVED

MeSH Terms

Conditions

Social Isolation

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Martha L Bruce, PhD, MPH

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 15, 2019
• First Posted: October 18, 2019
• Study Start: June 16, 2017
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)