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Completed

NCT Number: NCT04772820

Feasibility of Remote Home Support Coaches (SOCIAL Study)

The goal of this this study is to develop and test the feasibility of a remotely delivered brief behavioral activation intervention to decrease the negative physical and psychological consequences of being homebound among older adults during the time of COVID.

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Key information

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Maryland School of Medicine, Baltimore, Maryland, United States

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About this study

The goal of this study is to develop and test the feasibility of a remotely delivered brief behavioral activation intervention to decrease the negative physical and psychological consequences of being homebound among older adults during the time of COVID.The intervention will focus on decreasing the impact of social isolation, inactivity and poor nutrition on old people during a time when many in-person social activities are not possible. It will be delivered through telephone and other communication tools that allow remote (i.e. not in person) communication over 10 sessions. Subjects will be a total of 60 people aged 75 years an older, who will be recruited from primary care in the Boston MA region and senior living facilities in the Baltimore MD region. Coaches will be trained using an on-line based modules developed to support this intervention. Self-report outcomes will be measured by telephone at baseline and 4-month follow-up.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • • Men or women who are 75 years or older
  • Must be a patient of Mass General Brigham affiliated with Primary Care Physician departments in Boston, MA OR be a resident of Brightview Senior Living and Assisted Living facilities near Baltimore, MD

Exclusion criteria

  • • Men or women who are 74 years and younger
  • Participants who are not affiliated with Primary Care Physician departments at Mass General Brigham or a resident of an assisted living facility in Baltimore, MD
  • Unable to adequately complete the Evaluation to Provide Consent

Treatment and study plan

Telephone-based coaching

Behavioral

A telephone-based brief behavioral activation coaching program that will involve 10 sessions over 4 months. Sessions will focus on helping people to identify meaningful activities that they can safely do to decrease loneliness, increase physical activity and improve nutrition.

Other names: Remote coaching

Primary outcomes

  1. Physical Activity - Self-report survey to measure engagement in activities

    Time frame: change from baseline to 4-month follow-up

    Yale Physical Activity Survey (self-report)

  2. Loneliness assessment - 20 item, self-report assessment to measure loneliness

    Time frame: change from baseline to 4-month follow-up

    UCLA Loneliness Scale 3.0 (self-report) 20 item, self-report assessment to measure loneliness. Scale from 1(never) to 4(often)

  3. Physical Activity - step activity monitor to track daily steps walked

    Time frame: change in steps from the first week of study to final week (week 16) of study

    average steps walked per day

Secondary outcomes

  1. PROMIS Short form to measure level 2 adult depression

    Time frame: change from baseline to 4-month follow up

    PROMIS Depression (Short Form 8-item, self report)

  2. PROMIS short-form to measure anxiety in adults

    Time frame: change from baseline to 4-month follow up

    PROMIS Anxiety (Short form 8-item, self report)

  3. Late Life Function Instrument to assess functionality in elderly

    Time frame: change from baseline to 4-month follow up

    Late Life Function Instrument (LLFDI - self report)

  4. Late Life Function Instrument to access disability in elderly

    Time frame: change from baseline to 4-month follow up

    Late Life Disability Instrument (LLFDI - self report)

  5. Duke Social Support short scale to measure social support among older people

    Time frame: change from baseline to 4-month follow up

    Duke Social Support Index (self-report)

  6. Mini-nutritional assessment to determine if there is risk of malnourishment

    Time frame: change from baseline to 4-month follow up

    Mini-nutritional assessment - Short Form

  7. Likert 0-7 rating scale of participants satisfaction with the program

    Time frame: 4 month follow-up

    Likert rating of satisfaction

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • National Institute on Aging (NIA)
  • University of Maryland, Baltimore

Registry information

Official study title

The SOCIAL Study: Feasibility of Remote Home Support Coaches to Decrease the Physical and Psychological Impact of Social Distancing on Older Adults

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 26, 2021
Registry last updated
Apr 25, 2023

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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