Tele-BA for Home-Delivered Meals Clients

Social Isolation Clinical Trial

Official title:

Improving Social Connectedness in Home Delivered Meals Clients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04131790
• Other study ID #: D19169
• Status: Completed
• Phase: N/A
• Start date: June 16, 2017
• Est. completion date: September 1, 2020

Study information

• Verified date: October 2020
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: September 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Social Isolation

Intervention

Behavioral:
• Tele-Behavioral Activation
Five 1-hour sessions of BA delivered by a trained interventionist via video-conferencing
• Tele-Friendly Visiting
Five 1-hour FV sessions delivered by a trained interventionist via video-conferencing

Locations

Country	Name	City	State
United States	University of Texas	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acceptance of the Tele-BA intervention using a modified version of the Treatment Evaluation Inventory (TEI)	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.	6-weeks follow-up (immediately post-intervention)
Other	Change over time in social activities participation using the Social Engagement/Activities Questionnaire (SEAQ)	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.	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	Change over time in coping strategies using the Brief COPE	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.	Baseline, 6-week follow-up (immediately post-intervention), 12-week follow up (12 weeks post-intervention), 12-month follow-up (12-months post-intervention).
Primary	Change over time in social support measured using the Duke Social Support Index (DSSI)	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.	Baseline, 6-week follow-up (immediately post-intervention), 12-week follow up (12 weeks post-intervention), 12-month follow-up (12-months post-intervention).
Primary	Change over time in perceived social isolation measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Social Isolation Scale	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.	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	Change over time in depression symptomatology measured using the Patient Health Questionnaire-9 (PHQ-9)	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.	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	Change over time in functional disability measured using the World Health Organization Disability Assessment Schedule (WHODAS 2.0)	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.	Baseline, 6-week follow-up (immediately post-intervention), 12-week follow up (12 weeks post-intervention), 12-month follow-up (12-months post-intervention).