Feasibility of Remote Home Support Coaches (SOCIAL Study)

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04772820
• Other study ID #: 2020P004113
• Secondary ID: 3P30AG031679-10S
• Status: Completed
• Phase: N/A
• Start date: October 15, 2021
• Est. completion date: November 30, 2022

Study information

• Verified date: April 2023
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Isolation
• Loneliness
• Malnutrition
• Sedentary Behavior

Intervention

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.

Locations

Country	Name	City	State
United States	University of Maryland School of Medicine	Baltimore	Maryland
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Activity - Self-report survey to measure engagement in activities	Yale Physical Activity Survey (self-report)	change from baseline to 4-month follow-up
Primary	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
Primary	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	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
Secondary	PROMIS short-form to measure anxiety in adults	PROMIS Anxiety (Short form 8-item, self report)	change from baseline to 4-month follow up
Secondary	Late Life Function Instrument to assess functionality in elderly	Late Life Function Instrument (LLFDI - self report)	change from baseline to 4-month follow up
Secondary	Late Life Function Instrument to access disability in elderly	Late Life Disability Instrument (LLFDI - self report)	change from baseline to 4-month follow up
Secondary	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
Secondary	Mini-nutritional assessment to determine if there is risk of malnourishment	Mini-nutritional assessment - Short Form	change from baseline to 4-month follow up
Secondary	Likert 0-7 rating scale of participants satisfaction with the program	Likert rating of satisfaction	4 month follow-up