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NCT07475039
Project HOPEFUL: A PN-RCT With Implementation Science
NA trial testing Standardized and manualized warm calls from providers trained in the BE training in Older Adults (50-90 Years) in 400 participants. Currently enrolling.
30 August 2030
Quick facts
| Lead sponsor | University of Florida |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 400 |
| Start date | 5 September 2025 |
| Primary completion | 30 August 2030 |
| Estimated completion | 30 August 2030 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Standardized and manualized warm calls from providers trained in the BE training
- Standardized and manualized warm calls from providers trained in the BE training + ASIST training
Conditions studied
- Older Adults (50-90 Years) — all drugs for Older Adults (50-90 Years) →
- Mental Health — all drugs for Mental Health →
- Depression and Suicide Ideation — all drugs for Depression and Suicide Ideation →
- Social Functioning — all drugs for Social Functioning →
Sponsor
University of Florida
Who can join
55 and older, any sex, with Older Adults (50-90 Years) or Mental Health. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07475039
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07475039 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Florida
- Last refreshed: 16 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07475039.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing