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Completed

NCT Number: NCT04131790

Tele-BA for Home-Delivered Meals Clients

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

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas

Austin, Texas, 78712, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tele-Behavioral Activation

Behavioral

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

Tele-Friendly Visiting

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Change over time in depression symptomatology measured using the Patient Health Questionnaire-9 (PHQ-9)

    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 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.

  2. Change over time in functional disability measured using the World Health Organization Disability Assessment Schedule (WHODAS 2.0)

    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 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 outcomes

  1. Acceptance of the Tele-BA intervention using a modified version of the Treatment Evaluation Inventory (TEI)

    Time frame: 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.

  2. Change over time in social activities participation using the Social Engagement/Activities Questionnaire (SEAQ)

    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 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.

  3. Change over time in coping strategies using the Brief COPE

    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 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.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • University of Texas at Austin

Registry information

Official study title

Improving Social Connectedness in Home Delivered Meals Clients

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Oct 18, 2019
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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