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NCT07475039

Project HOPEFUL: A PN-RCT With Implementation Science

Recruiting now NA Last updated 16 March 2026
What this trial tests

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.

Timeline
5 September 2025
Primary endpoint
30 August 2030
30 August 2030

Quick facts

Lead sponsorUniversity of Florida
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment400
Start date5 September 2025
Primary completion30 August 2030
Estimated completion30 August 2030
Sites1 location across United States

Drugs / interventions tested

Conditions studied

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.

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Other recruiting trials for Older Adults (50-90 Years)

Currently open trials in the same condition.

Other University of Florida trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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