Project HOPEFUL: A PN-RCT With Implementation Science

Official title

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

Overview

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.

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 outcome measures

• Social Provisions Scale (SPS-5) [Time frame: Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up]
• University of California, Los Angeles Loneliness Scale [Time frame: Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up]
• Patient Health Questionnaire - PHQ-9 [Time frame: Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up]
• Short Form Health Survey (SF-12) [Time frame: Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up]
• Interpersonal Needs Questionnaire (INQ-15) [Time frame: Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up]
• Implementation Science Sustainability Survey Measures: AIM [Time frame: Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up]
• Implementation Science Sustainability Survey Measures: IAM [Time frame: Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up]
• Implementation Science Sustainability Survey Measures: FIM [Time frame: Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up]
• Implementation Science Sustainability Survey Measures: SUS [Time frame: Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up]
• Household Food Security Survey Module - 10 item (Adult Only) [Time frame: Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up]

Secondary outcome measures (2)

• Session Rating Scale [Time frame: Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up]
• Consolidated Framework for Implementation Science (CFIR) Interview Guide Tool [Time frame: Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up]

Eligibility criteria

In order to be eligible as a participant in this study, an individual must meet all of the following criteria:

• Provision of verbal informed consent
• Classify as an Older Adult (65+)
• Stated willingness and ability to comply with all study procedures
• Receive home and community-based services (HCBS) through the Aging Services Network (i.e. HDM (home delivered meals services), CM (congregate meals), etc.)
• 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:

• Provision of written informed consent
• State willingness to comply with all study procedures
• Be a staff or volunteer within the ASN (Aging Services Network), specifically within the triple As and aging entities we have partnered with
• 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)
• 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:

• Provision of written informed consent
• State willingness to comply with all study procedures
• 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:

• Had a dementia diagnosis, or another form of cognitive impairment, and/or hearing impairment that would preclude phone conversation.
• Participation in another warm calling behavioral treatment or intervention study simultaneously occurring

Exclusion criteria for trained natural helpers:

• 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)
• Participation in another warm calling behavioral treatment or intervention study simultaneously occurring

Exclusion criteria for aging leaders:

• Has not worked with the study team directly in implementing the 8-week treatment
• Is not familiar with the implementation of the program

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Florida — Gainesville

Identifiers

NCT: NCT07475039 · IRB202501649 · 90INNU0058-01-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗