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Clinical Trials/NCT04131790
NCT04131790CompletedNot Applicable

Improving Social Connectedness in Home Delivered Meals Clients

Dartmouth-Hitchcock Medical Center1 site in 1 country89 target enrollmentStarted: June 16, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
89
Locations
1
Primary Endpoint
Change over time in perceived social isolation measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Social Isolation Scale

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
60 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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).

Intervention: Tele-Behavioral Activation (Behavioral)

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.

Intervention: Tele-Friendly Visiting (Behavioral)

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • 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).)
  • 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).)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Martha L. Bruce

Professor

Dartmouth-Hitchcock Medical Center

Study Sites (1)

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