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Feasibility of Remote Home Support Coaches (SOCIAL Study)

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ClinicalTrials.gov Identifier: NCT04772820
Recruitment Status : Not yet recruiting
First Posted : February 26, 2021
Last Update Posted : March 24, 2021
Sponsor:
Collaborators:
University of Maryland, Baltimore
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Shalendar Bhasin, MD, Brigham and Women's Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Malnutrition Isolation Depression Anxiety Sedentary Behavior Loneliness Behavioral: Telephone-based coaching Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This project is a single-group unblinded feasibility study to explore a new telephone-based behavioral activation intervention to support homebound older people. If this intervention appears to be feasible, acceptable, and to show preliminary evidence of efficacy the aim will be to evaluate it in a phase III efficacy trial.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The SOCIAL Study: Feasibility of Remote Home Support Coaches to Decrease the Physical and Psychological Impact of Social Distancing on Older Adults
Estimated Study Start Date : April 2021
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Primary Aim
Brief Behavioral Activation coaching will be delivered by telephone and other remote technology by trained coaches. Over 10 sessions, the coaches will help people to find meaningful activities to decrease loneliness, increase physical activity and improve nutrition.
Behavioral: Telephone-based coaching
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 Name: Remote coaching




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04772820


Contacts
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Contact: Nancy Latham, PhD 617-999-9195 nklatham@bwh.harvard.edu
Contact: Deatrice S Moore 617-872-6096 dsmoore@bwh.harvard.edu

Locations
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United States, Maryland
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
Contact: Denise Orwig, PhD    410-706-2406    DORWIG@som.umaryland.edu   
Principal Investigator: Denise Orwig, PhD         
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Contact: Nancy Latham, PhD    617-999-9195    nklatham@bwh.harvard.edu   
Principal Investigator: Nancy Latham, PhD         
Sponsors and Collaborators
Brigham and Women's Hospital
University of Maryland, Baltimore
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Shalender Bhasin, MD Brigham and Women's Hospital
Principal Investigator: Nancy Latham, PhD Brigham and Women's Hospital
Principal Investigator: Denise Orwig, PhD University of Maryland, College Park
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Responsible Party: Shalendar Bhasin, MD, Principal Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT04772820    
Other Study ID Numbers: 2020P004113
3P30AG031679-10S2 ( U.S. NIH Grant/Contract )
First Posted: February 26, 2021    Key Record Dates
Last Update Posted: March 24, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shalendar Bhasin, MD, Brigham and Women's Hospital:
Covid19
Physical Inactivity
Social Isolation
Inadequate Nutrition
Older Adult
Social Distancing
Remote Home Support
Physical
Psychological
loneliness
behavioral activation
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders