Feasibility of Remote Home Support Coaches (SOCIAL Study)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Malnutrition, Isolation, Depression, Anxiety, Sedentary Behavior, Loneliness

Intervention / Treatment
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* Behavioral: Telephone-based coaching


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Primary Aim<br>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<br>* 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.<br>* Other names: Remote coaching;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity - Self-report survey to measure engagement in activities | Yale Physical Activity Survey (self-report) | change from baseline to 4-month follow-up | 
| Loneliness assessment - 20 item, self-report assessment to measure loneliness | UCLA Loneliness Scale 3.0 (self-report) 20 item, self-report assessment to measure loneliness. Scale from 1(never) to 4(often) | change from baseline to 4-month follow-up | 
| Physical Activity - step activity monitor to track daily steps walked | average steps walked per day | change in steps from the first week of study to final week (week 16) of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS Short form to measure level 2 adult depression | PROMIS Depression (Short Form 8-item, self report) | change from baseline to 4-month follow up | 
| PROMIS short-form to measure anxiety in adults | PROMIS Anxiety (Short form 8-item, self report) | change from baseline to 4-month follow up | 
| Late Life Function Instrument to assess functionality in elderly | Late Life Function Instrument (LLFDI - self report) | change from baseline to 4-month follow up | 
| Late Life Function Instrument to access disability in elderly | Late Life Disability Instrument (LLFDI - self report) | change from baseline to 4-month follow up | 
| Duke Social Support short scale to measure social support among older people | Duke Social Support Index (self-report) | change from baseline to 4-month follow up | 
| Mini-nutritional assessment to determine if there is risk of malnourishment | Mini-nutritional assessment - Short Form | change from baseline to 4-month follow up | 
| Likert 0-7 rating scale of participants satisfaction with the program | Likert rating of satisfaction | 4 month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Covid19, Physical Inactivity, Social Isolation, Inadequate Nutrition, Older Adult, Social Distancing, Remote Home Support, Physical, Psychological, loneliness, behavioral activation