Tele-BA for Home-Delivered Meals Clients

Not Applicable

Completed

• Conditions: Social Isolation

• 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

Study Timeline

• Study Start: 2017-06-16
• Study First Submitted: 2019-10-15
• Study First Submitted QC: 2019-10-16
• Study First Posted: 2019-10-18
• Primary Completion: 2020-09-01
• Study Completion: 2020-09-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-05
• Last Update Posted: 2020-10-08

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

Primary Outcome Measures

Name	Time	Method
Change over time in perceived social isolation measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Social Isolation Scale	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)	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

Name	Time	Method
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