Recruiting

Project HOPEFUL: A PN-RCT With Implementation Science

ClinicalTrials.gov IDNCT07475039

PhaseNA

Enrollment400

SponsorUniversity of Florida

Age55 Years

SexALL

I'm interested View official listing

Conditions studied

Older Adults (50-90 Years), Mental Health, Depression and Suicide Ideation, Social Functioning, Quality of Life, Thwarted Belongingness, Perceived Burdensomeness

About this study

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.

Interventions

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.

Primary outcomes

Social Provisions Scale (SPS-5) (Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up)
University of California, Los Angeles Loneliness Scale (Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up)
Patient Health Questionnaire - PHQ-9 (Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up)
Short Form Health Survey (SF-12) (Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up)
Interpersonal Needs Questionnaire (INQ-15) (Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up)
Implementation Science Sustainability Survey Measures: AIM (Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up)
Implementation Science Sustainability Survey Measures: IAM (Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up)
Implementation Science Sustainability Survey Measures: FIM (Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up)

Eligibility information

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

Study locations

University of Florida, Gainesville, Florida 32611 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-30.