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RECRUITING

NCT07475039

Project HOPEFUL: A PN-RCT With Implementation Science

Sponsor: University of Florida

View on ClinicalTrials.gov

Summary

This PN-RCT replicates and evaluates an 8-week warm calling treatment (i.e. caring contacts) delivered to older adults receiving home and community-based services (HCBS; classified as "homebound") in 20-30 minute call "dosages", across 3 conditions, while adding in implementation science measures at multiple levels. Conditions include 2 treatment (i.e. treatment provided by helpers trained in a standardized and manualized Belongingness and Empathy training grounded in narrative reminiscence and the befriending literature (BE condition), and treatment provided by helpers trained in BE + a standardized, manualized, and evidence based suicide intervention training, the Aging Variant of LivingWorks ASIST (BE + ASIST condition), and 1 control (no treatment during the trial; opportunity to receive treatment after the 8 weeks). At the conclusion of treatment, acceptability, appropriateness, feasibility, useability, and sustainability of the program will be evaluated by interventionists, senior center leadership, and regional leadership.

Official title: Project HOPEFUL (Helping Older PErsons Find Useful Links): Replicating a Partially Nested Randomized Control Trial With Implementation Science

Key Details

Gender

All

Age Range

55 Years - Any

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2025-09-05

Completion Date

2030-08-30

Last Updated

2026-03-16

Healthy Volunteers

Yes

Conditions

Older Adults (50-90 Years)Mental Health Depression and Suicide Ideation Social Functioning Quality of Life Thwarted Belongingness Perceived Burdensomeness

Interventions

BEHAVIORAL

Standardized and manualized warm calls from providers trained in the BE training

Weekly call dosages averaging 20-30 minutes each, for 8 weeks duration; with a 6 month follow up.

BEHAVIORAL

Standardized and manualized warm calls from providers trained in the BE training + ASIST training

Weekly call dosages averaging 20-30 minutes each, for 8 weeks duration; with a 6 month follow up.

In order to be eligible as a participant in this study, an individual must meet all of the following criteria: 1. Provision of verbal informed consent 2. Classify as an Older Adult (65+) 3. Stated willingness and ability to comply with all study procedures 4. Receive home and community-based services (HCBS) through the Aging Services Network (i.e. HDM (home delivered meals services), CM (congregate meals), etc.) 5. Be affiliated with the triple As and aging entities we have partnered with In order to be eligible to be a trained provider in this study, an individual must meet all of the following criteria: 1. Provision of written informed consent 2. State willingness to comply with all study procedures 3. Be a staff or volunteer within the ASN (Aging Services Network), specifically within the triple As and aging entities we have partnered with 4. Meet Wymann and colleagues (2008) criteria for being a "natural helpers"42 (i.e. be warm, empathic, and having ongoing interaction with participants through one's job role) 5. Be recommended by the aging entity leadership as meeting these qualifications In order to be eligible to be a leadership personnel in this study, an individual must meet all of the following criteria: 1. Provision of written informed consent 2. State willingness to comply with all study procedures 3. Be a in a leadership position within the aging entity or triple A in which we partnered, and have worked with the study team in helping implement the 8 week program Exclusion criteria for Participants: 1. Had a dementia diagnosis, or another form of cognitive impairment, and/or hearing impairment that would preclude phone conversation. 2. Participation in another warm calling behavioral treatment or intervention study simultaneously occurring Exclusion criteria for trained natural helpers: 1. 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) 2. Participation in another warm calling behavioral treatment or intervention study simultaneously occurring Exclusion criteria for aging leaders: 1. Has not worked with the study team directly in implementing the 8-week treatment 2. Is not familiar with the implementation of the program

Locations (1)

University of Florida

Gainesville, Florida, United States