Feasibility of Remote Home Support Coaches (SOCIAL Study)
Primary Purpose
Malnutrition, Isolation, Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telephone-based coaching
Sponsored by
About this trial
This is an interventional supportive care trial for Malnutrition focused on measuring Covid19, Physical Inactivity, Social Isolation, Inadequate Nutrition, Older Adult, Social Distancing, Remote Home Support, Physical, Psychological, loneliness, behavioral activation
Eligibility Criteria
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
Sites / Locations
- University of Maryland School of Medicine
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Primary Aim
Arm Description
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.
Outcomes
Primary Outcome Measures
Physical Activity - Self-report survey to measure engagement in activities
Yale Physical Activity Survey (self-report)
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)
Physical Activity - step activity monitor to track daily steps walked
average steps walked per day
Secondary Outcome Measures
PROMIS Short form to measure level 2 adult depression
PROMIS Depression (Short Form 8-item, self report)
PROMIS short-form to measure anxiety in adults
PROMIS Anxiety (Short form 8-item, self report)
Late Life Function Instrument to assess functionality in elderly
Late Life Function Instrument (LLFDI - self report)
Late Life Function Instrument to access disability in elderly
Late Life Disability Instrument (LLFDI - self report)
Duke Social Support short scale to measure social support among older people
Duke Social Support Index (self-report)
Mini-nutritional assessment to determine if there is risk of malnourishment
Mini-nutritional assessment - Short Form
Likert 0-7 rating scale of participants satisfaction with the program
Likert rating of satisfaction
Full Information
NCT ID
NCT04772820
First Posted
February 23, 2021
Last Updated
April 21, 2023
Sponsor
Brigham and Women's Hospital
Collaborators
University of Maryland, Baltimore, National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT04772820
Brief Title
Feasibility of Remote Home Support Coaches (SOCIAL Study)
Official Title
The SOCIAL Study: Feasibility of Remote Home Support Coaches to Decrease the Physical and Psychological Impact of Social Distancing on Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
October 15, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
University of Maryland, Baltimore, National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Primary Aim
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Telephone-based coaching
Other Intervention Name(s)
Remote coaching
Intervention Description
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.
Primary Outcome Measure Information:
Title
Physical Activity - Self-report survey to measure engagement in activities
Description
Yale Physical Activity Survey (self-report)
Time Frame
change from baseline to 4-month follow-up
Title
Loneliness assessment - 20 item, self-report assessment to measure loneliness
Description
UCLA Loneliness Scale 3.0 (self-report) 20 item, self-report assessment to measure loneliness. Scale from 1(never) to 4(often)
Time Frame
change from baseline to 4-month follow-up
Title
Physical Activity - step activity monitor to track daily steps walked
Description
average steps walked per day
Time Frame
change in steps from the first week of study to final week (week 16) of study
Secondary Outcome Measure Information:
Title
PROMIS Short form to measure level 2 adult depression
Description
PROMIS Depression (Short Form 8-item, self report)
Time Frame
change from baseline to 4-month follow up
Title
PROMIS short-form to measure anxiety in adults
Description
PROMIS Anxiety (Short form 8-item, self report)
Time Frame
change from baseline to 4-month follow up
Title
Late Life Function Instrument to assess functionality in elderly
Description
Late Life Function Instrument (LLFDI - self report)
Time Frame
change from baseline to 4-month follow up
Title
Late Life Function Instrument to access disability in elderly
Description
Late Life Disability Instrument (LLFDI - self report)
Time Frame
change from baseline to 4-month follow up
Title
Duke Social Support short scale to measure social support among older people
Description
Duke Social Support Index (self-report)
Time Frame
change from baseline to 4-month follow up
Title
Mini-nutritional assessment to determine if there is risk of malnourishment
Description
Mini-nutritional assessment - Short Form
Time Frame
change from baseline to 4-month follow up
Title
Likert 0-7 rating scale of participants satisfaction with the program
Description
Likert rating of satisfaction
Time Frame
4 month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shalender Bhasin, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nancy Latham, PhD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Denise Orwig, PhD
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Feasibility of Remote Home Support Coaches (SOCIAL Study)
We'll reach out to this number within 24 hrs