Feasibility of Remote Home Support Coaches (SOCIAL Study)

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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Malnutrition; Anxiety; Sedentary Behavior; Loneliness; Isolation
• Intervention / Treatment: Behavioral: Telephone-based coaching

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland School of Medicine
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: University of Maryland, Baltimore; National Institute on Aging (NIA)
• Investigators: Principal Investigator: Nancy Latham, PhD, Brigham and Women's Hospital; Principal Investigator: Denise Orwig, PhD, University of Maryland School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: February 23, 2021
• First Posted (Actual): February 26, 2021

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 21, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Covid19; behavioral activation; Psychological; Social Isolation; Physical Inactivity; loneliness; Older Adult; Inadequate Nutrition; Social Distancing; Remote Home Support; Physical
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: 2020P004113; 3P30AG031679-10S2 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No