Feasibility of Remote Home Support Coaches (SOCIAL Study)

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04772820

Collaborator

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

Enrollment

Locations

Arm

8.5

Anticipated Duration (Months)

Patients Per Site

3.5

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

Anticipated 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.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

Actual Study Start Date :

Oct 15, 2021

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: 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 Names: Remote coaching

Arm

Intervention/Treatment

Other: 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 Names:

Remote coaching

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

75 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Maryland School of Medicine	Baltimore	Maryland	United States	21201
2	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

Brigham and Women's Hospital
University of Maryland, Baltimore
National Institute on Aging (NIA)

Investigators

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 School of Medicine