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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04772820
Other study ID # 2020P004113
Secondary ID 3P30AG031679-10S
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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