Status:
COMPLETED
The BE WITH Project: A Partially Nested Randomized Control Trial (PN-RCT)
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Georgia State University
Department of Health and Human Services
Conditions:
Older Adults
Mental Health
Eligibility:
All Genders
55+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to learn if the BE WITH (Belonging through Empathy With Intentional Targeted Helping) innovation delivered to older adults improves their mental health. It will also...
Detailed Description
This study is a partially nested randomized controlled trial research design (PN-RCT) with a two-level structure of clients (level-1) nested within callers (level-2) for the two treatment conditions w...
Eligibility Criteria
Inclusion
- Inclusion Criteria for older adult participants:
- Provision of verbal informed consent,
- Classify as an Older Adult (55+),
- Stated willingness and ability to comply with all study procedures,
- Receive nutrition services through the Aging Services Network (i.e. either HDM (home delivered meals services) or CM (congregate meals)), and
- Be affiliated with one of the 25 senior centers we will contract with through a Memorandum of Understanding.
- Inclusion Criteria for trained providers:
- Provision of written informed consent,
- State willingness to comply with all study procedures,
- Be a staff or volunteer within the ASN (Aging Services Network), specifically within the 25 senior centers we are working with,
- Meet criteria identified by Wymann and colleagues (2009) for being a "natural helpers" (i.e. be warm, empathic, and having ongoing interaction with participants through one's job role), and
- Be recommended by the senior center leadership as meeting these qualifications.
- Exclusion Criteria for older adult participants:
- Had a dementia diagnosis, or another form of cognitive impairment, and/or hearing impairment that would preclude phone conversation, and
- Participation in another warm calling behavioral treatment or intervention study simultaneously occurring in this state.
- The reasons given to exclude participants with dementia/cognitive impairment diagnoses from large-scale clinical research are partially related to the concern of a potential risk of abuse and exploitation. Further, those with cognitive impairment are not able to give informed consent, and there are measurement challenges with behavioral health data.
- Exclusion Criteria for trained helpers:
- Does not have ongoing interactions with potential old adult participants (i.e. is a part of an optimized nutrition service provider in which they do not serve the same older adults consistently over time), and
- Participation in another warm calling behavioral treatment or intervention study simultaneously occurring in this state.
Exclusion
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2024
Estimated Enrollment :
671 Patients enrolled
Trial Details
Trial ID
NCT07204444
Start Date
June 1 2021
End Date
October 25 2024
Last Update
November 12 2025
Active Locations (1)
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1
Older Adults' Homes; Treatment Provided Over the Phone
Atlanta, Georgia, United States, 30318