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Tele-BA for Home-Delivered Meals Clients

Improving Social Connectedness in Home Delivered Meals Clients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04131790
Enrollment
89
Registered
2019-10-18
Start date
2017-06-16
Completion date
2020-09-01
Last updated
2020-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Social Isolation

Keywords

Loneliness, Homebound, Behavioral Activation

Brief summary

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

Interventions

BEHAVIORALTele-Behavioral Activation

Five 1-hour sessions of BA delivered by a trained interventionist via video-conferencing

BEHAVIORALTele-Friendly Visiting

Five 1-hour FV sessions delivered by a trained interventionist via video-conferencing

Sponsors

University of Texas at Austin
CollaboratorOTHER
Dartmouth-Hitchcock Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
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.
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.

Secondary

MeasureTime frameDescription
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.
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.

Other

MeasureTime frameDescription
Change over time in social activities participation using the Social Engagement/Activities Questionnaire (SEAQ)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 homebound older adults' participation in a range of social-group activities, interpersonal interaction activities with family and friends, and solitary activities while taking account of their physical and functional health limitations and social circumstances under which they live. Items are rated using a Likert scale (6-point scale: 'not at all' = 0 to 'every day' = 5). Total scores are calculated by summing responses to items 1-10; total scores range 0-50.
Change over time in coping strategies using the Brief COPEBaseline, 6-week follow-up (immediately post-intervention), 12-week follow up (12 weeks post-intervention), 12-month follow-up (12-months post-intervention).A 16-item self-report questionnaire used to measure use of coping strategies for difficult situations. Items are rated using a Likert scale (4-point scale: 'not at all' = 0 to 'a lot' = 3). Total scores are calculated by summing responses to items 1-16; total scores range 0-48.
Acceptance of the Tele-BA intervention using a modified version of the Treatment Evaluation Inventory (TEI)6-weeks follow-up (immediately post-intervention)An 11-item self-report questionnaire used to measure intervention acceptability. For this project, reference to Treatment will be substituted with Tele-BA. Items are rated using a 7-point Likert scale. Response values range 1-7 with different verbal anchors for each item. Total scores are calculated by summing responses to items 1-11; total scores range 11-77. The TEI consists of an 8-item General Acceptability subscale and a 3-item Negative Aspects (e.g., discomfort) subscale.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026