Feasibility of Remote Home Support Coaches (SOCIAL Study)

NCT04772820 | Completed DMC

• 2 other identifiers: 2020P0041133P30AG031679-10S2
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

Malnutrition; Isolation; Depression; Anxiety; Sedentary Behavior; Loneliness

Keywords

Covid19; Physical Inactivity; Social Isolation; Inadequate Nutrition; Older Adult; Social Distancing; Remote Home Support; Physical; Psychological; loneliness; behavioral activation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• PROMIS Short form to measure level 2 adult depression

  change from baseline to 4-month follow up

• PROMIS short-form to measure anxiety in adults

  change from baseline to 4-month follow up

• Late Life Function Instrument to assess functionality in elderly

  change from baseline to 4-month follow up

• Late Life Function Instrument to access disability in elderly

  change from baseline to 4-month follow up

• Duke Social Support short scale to measure social support among older people

  change from baseline to 4-month follow up

Study Arms (1)

Primary Aim

OTHER

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

Interventions

Telephone-based coaching BEHAVIORAL

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.

Also known as: Remote coaching

Primary Aim

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Malnutrition; Depression; Anxiety Disorders; Sedentary Behavior; COVID-19; Social Isolation

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Behavioral Symptoms; Behavior; Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Social Behavior

Study Officials

• 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, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: February 26, 2021
• Study Start: October 15, 2021
• Primary Completion: June 30, 2022
• Study Completion: November 30, 2022
• Last Updated: April 25, 2023

Record last verified: 2023-04

Locations

US (2)