Trials / Recruiting

RecruitingNCT07475039

Project HOPEFUL: A PN-RCT With Implementation Science

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

Status: Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 400 (estimated)

Sponsor: University of Florida · Academic / Other
Sex: All
Age: 55 Years
Healthy volunteers: Accepted

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.

Detailed description

This clinical trial replicates and evaluates the BE WITH caring contacts program, equipping the Aging Services Network (ASN) with proven skills to reduce social isolation, loneliness, and elevated suicidality, while also promoting social support/well-being, and learning from the Aging Services Network about what is and is not working for long term sustainability. The study team will also learn specifically what provider behaviors contributed to mental health improvements through the quantitative coding and analysis of audio files as well as the long-term impacts of receiving the 8 week treatment on older adults' social connections and connecting behaviors (6 follow up measurement occasions). Overall Study Design: This study is a partially nested randomized controlled trial research design (PN-RCT) with a two-level structure of clients (level-1) nested within callers (level-2) for the two treatment conditions. Given that outcomes for older adults receiving calls from the same treatment provider may be more similar than for those who receive calls from a different treatment provider, the use of multilevel modeling can account for these data dependencies. Primary Objectives: To (a) replicate the BE WITH Innovation, (b) evaluate the mental health outcomes of older adults receiving HCBS that receive it, while (c) gaining new knowledge on the implementation and sustainability of BE WITH by learning what is and isn't working from interventionists, senior center leadership, and regional leadership. Secondary Objectives: Enhance the ability of natural helpers to provide standardized, manualized, and evidence based treatment to older adults receiving HCBS. Primary Endpoint: Reduction in social isolation, loneliness, and elevated suicidality and improved social support/overall quality of life for older adult participants receiving HCBS. New knowledge on the acceptability, appropriateness, feasibility, useability, and sustainability. Secondary Endpoints: Improved frequency of empathic and suicide intervention best practice behaviors by trained providers. The primary endpoints for older adult participants will be assessed at baseline and every two weeks for a total of 5 measurement occasions, and at 6 month follow up. The primary endpoints for aging network stakeholders will be assessed post-treatment. Secondary endpoints will be assessed through the quantitative coding of the recorded audio files of treatment dosages. Hypotheses include: (a) participants in the BE and BE + ASIST treatment conditions will experience statistically significant improvements across all measures when compared with those in the control condition over the course of the 8-week treatment, (b) outcome improvements for those in treatment conditions will be more pronounced for those who begin the period at greater risk (assigned high risk tier at baseline), (c) the BE WITH innovation will be found to be appropriate, feasible, and sustainable at multiple levels (i.e. interventionists, senior center leadership, regional leadership), and (d) behavioral improvements in social connections (as a result of building one's social connections plan as part of the treatment) will be found in those that participated in the two treatment groups, and not in the control group. The study team will also be tracking the long-term outcomes of receiving the treatment on connections and connecting behaviors that older adults have in their life. The implementation of a "connections plan" (CP) within the BE training is a new aspect of this trial. This plan will be introduced in the first call dosage and revisited each call. Evaluations of it will take place at pre and post treatment, with monthly check ins, and then finally at 6 month follow up. The investigators also hypothesize that the connecting behaviors will (a) improve during treatment, and (b) be retained at 6 month follow up.

Conditions

Interventions

Type	Name	Description
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.

Timeline

Start date: 2025-09-05
Primary completion: 2030-08-30
Completion: 2030-08-30
First posted: 2026-03-16
Last updated: 2026-03-16

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07475039. Inclusion in this directory is not an endorsement.