Project HOPEFUL: A PN-RCT With Implementation Science
Recruiting · NCT07475039 · Interventional (participants receive a specific treatment) · Lead sponsor:
University of Florida
View the official record on ClinicalTrials.gov →
Interventions studied
Standardized and manualized warm calls from providers trained in the BE trainingStandardized and manualized warm calls from providers trained in the BE training + ASIST training
What this trial is about
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.
Who can take part
Age range
55 Years and older
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Eligibility criteria (as published)
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
Where it is running
1 location listed across 1 US state.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →