Tele-BA for Home-Delivered Meals Clients

Overview

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

Full Title of Study: “Improving Social Connectedness in Home Delivered Meals Clients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 1, 2020

Interventions

  • Behavioral: Tele-Behavioral Activation
    • Five 1-hour sessions of BA delivered by a trained interventionist via video-conferencing
  • Behavioral: Tele-Friendly Visiting
    • Five 1-hour FV sessions delivered by a trained interventionist via video-conferencing

Arms, Groups and Cohorts

  • 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).
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Change over time in social support measured using the Duke Social Support Index (DSSI)
    • Time Frame: Baseline, 6-week follow-up (immediately post-intervention), 12-week follow up (12 weeks post-intervention), 12-month follow-up (12-months post-intervention).
    • 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.
  • Change over time in perceived social isolation measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Social Isolation Scale
    • Time Frame: Baseline, 6-week follow-up (immediately post-intervention), 12-week follow up (12 weeks post-intervention), 12-month follow-up (12-months post-intervention).
    • 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.

Secondary Measures

  • Change over time in depression symptomatology measured using the Patient Health Questionnaire-9 (PHQ-9)
    • Time Frame: Baseline, 6-week follow-up (immediately post-intervention), 12-week follow up (12 weeks post-intervention), 12-month follow-up (12-months post-intervention).
    • 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.
  • Change over time in functional disability measured using the World Health Organization Disability Assessment Schedule (WHODAS 2.0)
    • Time Frame: Baseline, 6-week follow-up (immediately post-intervention), 12-week follow up (12 weeks post-intervention), 12-month follow-up (12-months post-intervention).
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Dartmouth-Hitchcock Medical Center
  • Collaborator
    • University of Texas at Austin
  • Provider of Information About this Clinical Study
    • Principal Investigator: Martha L. Bruce, Professor – Dartmouth-Hitchcock Medical Center
  • Overall Official(s)
    • Martha L Bruce, PhD, MPH, Principal Investigator, Dartmouth-Hitchcock Medical Center

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