Feasibility of Remote Home Support Coaches (SOCIAL Study)

Not Applicable

Completed

• Conditions: Anxiety; Isolation; Depression; Sedentary Behavior; Loneliness; Malnutrition
• Interventions: Behavioral: Telephone-based coaching

• Registration Number: NCT04772820
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2021-02-23
• Study First Submitted QC: 2021-02-23
• Study First Posted: 2021-02-26
• Study Start: 2021-10-15
• Primary Completion: 2022-06-30
• Study Completion: 2022-11-30
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-21
• Last Update Posted: 2023-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Primary Aim	Telephone-based coaching	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.

Primary Outcome Measures

Name	Time	Method
Physical Activity - Self-report survey to measure engagement in activities	change from baseline to 4-month follow-up	Yale Physical Activity Survey (self-report)
Loneliness assessment - 20 item, self-report assessment to measure loneliness	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)
Physical Activity - step activity monitor to track daily steps walked	change in steps from the first week of study to final week (week 16) of study	average steps walked per day

Secondary Outcome Measures

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

Trial Locations

Locations (2)

University of Maryland School of Medicine; 🇺🇸 Baltimore, Maryland, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States