NCT07475039 Project HOPEFUL: A PN-RCT With Implementation Science
| NCT ID | NCT07475039 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Florida |
| Condition | Older Adults (50-90 Years) |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-09-05 |
| Primary Completion | 2030-08-30 |
Trial Parameters
Eligibility Fast-Check
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Brief 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.
Eligibility Criteria
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 partic