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 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2025-09-05 with a primary completion date of 2030-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07475039 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, studying Older Adults (50-90 Years). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07475039 currently recruiting?
Yes, NCT07475039 is actively recruiting participants. Contact the research team at lshannonhouse@coe.ufl.edu for enrollment information.
Where is the NCT07475039 trial being conducted?
This trial is being conducted at Gainesville, United States.
Who is sponsoring the NCT07475039 clinical trial?
NCT07475039 is sponsored by University of Florida. The trial plans to enroll 400 participants.