MedPath

Tele-BA for Home-Delivered Meals Clients

Not Applicable
Completed
Conditions
Social Isolation
Interventions
Behavioral: Tele-Friendly Visiting
Behavioral: Tele-Behavioral Activation
Registration Number
NCT04131790
Lead Sponsor
Dartmouth-Hitchcock Medical Center
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
89
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Tele-Friendly VisitingTele-Friendly VisitingFriendly 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.
Tele-Behavioral ActivationTele-Behavioral ActivationManualized 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).
Primary Outcome Measures
NameTimeMethod
Change over time in perceived social isolation measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Social Isolation ScaleBaseline, 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.

Change over time in social support measured using the Duke Social Support Index (DSSI)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.

Secondary Outcome Measures
NameTimeMethod
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).

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.

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).

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.

Trial Locations

Locations (1)

University of Texas

🇺🇸

Austin, Texas, United States

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