Clinical trial NCT04131790: Tele-BA for Home-Delivered Meals Clients
Official title: Improving Social Connectedness in Home Delivered Meals Clients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Isolation
Keywords: Loneliness
Homebound
Behavioral Activation
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: University of Texas at Austin
First posted: 2019-10-18
Enrollment: 89
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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


Eligibility criteria: 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

Primary outcomes:
measure: Change over time in social support measured using the Duke Social Support Index (DSSI)
timeFrame: Baseline, 6-week follow-up (immediately post-intervention), 12-week follow up (12 weeks post-intervention), 12-month follow-up (12-months post-intervention).
measure: Change over time in perceived social isolation measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Social Isolation Scale
timeFrame: 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:
measure: Change over time in depression symptomatology measured using the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, 6-week follow-up (immediately post-intervention), 12-week follow up (12 weeks post-intervention), 12-month follow-up (12-months post-intervention).
measure: Change over time in functional disability measured using the World Health Organization Disability Assessment Schedule (WHODAS 2.0)
timeFrame: 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:
measure: Acceptance of the Tele-BA intervention using a modified version of the Treatment Evaluation Inventory (TEI)
timeFrame: 6-weeks follow-up (immediately post-intervention)
measure: Change over time in social activities participation using the Social Engagement/Activities Questionnaire (SEAQ)
timeFrame: Baseline, 6-week follow-up (immediately post-intervention), 12-week follow up (12 weeks post-intervention), 12-month follow-up (12-months post-intervention).
measure: Change over time in coping strategies using the Brief COPE
timeFrame: Baseline, 6-week follow-up (immediately post-intervention), 12-week follow up (12 weeks post-intervention), 12-month follow-up (12-months post-intervention).
Locations:
city: Austin
country: United States
facility: University of Texas
state: Texas
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Martha L Bruce, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.