Project HOPEFUL: A PN-RCT With Implementation Science

NCT07475039 | Recruiting DMC

• 2 other identifiers: IRB20250164990INNU0058-01-00
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Older adults; Intervention trial; Suicidality; Home Bound Meals; warm-calling

Outcome Measures

Primary Outcomes (10)

• Social Provisions Scale (SPS-5)

  The Social Provisions Scale (SPS-5) is a 5-item measure used to evaluate a participant's level of social support. It is a shortened version of the 10-item SPS and designed for use in research studies to reduce participant burden while maintaining strong psychometric properties. The SPS is based on a theory of social support developed by Irwin Weiss and uses one positive item to assess the social provisions of Attachment, Guidance, Social Integration, Reliable alliance, and Reassurance of worth. Each item is rated on a 4-point Likert scale, from "Strongly Disagree" to "Strongly Agree". Sample items include, "There is someone I could talk to about important decisions in my life", "I feel part of a group of people who share my attitudes and beliefs", and "There are people I can count on in an emergency." A total score is calculated by summing the responses to the 5 questions. The scores can range from 5 to 20, with higher scores indicating higher levels of perceived social support.

  Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up

• University of California, Los Angeles Loneliness Scale

  The three-item UCLA Loneliness Scale (Hughes et al., 2004) is a widely used instrument for measuring subjective feelings of loneliness. The scale assesses three core dimensions of loneliness through corresponding items: relational connectedness ("How often do you feel that you lack companionship?"), social connectedness ("How often do you feel left out?"), and self-perceived isolation ("How often do you feel isolated from others?"). Participants respond using a 3-point scale ranging from "hardly ever" to "often." Total scores range from 3 to 9, with higher scores indicating greater loneliness. The scale demonstrates good psychometric properties in middle-aged and older adult populations.

  Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up

• Patient Health Questionnaire - PHQ-9

  The Patient Health Questionnaire-9 (PHQ-9) is a 9-item measure to assess depressive symptoms in the past 2 weeks (Kroenke et al., 2001). The scale items correspond to the 9 diagnostic criteria for major depressive disorder. Respondents rate the frequency of each symptom on a 4-point scale ranging from "not at all" to "nearly every day." Sample items include "Little interest or pleasure in doing things" and "Poor appetite or overeating." Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. The PHQ-9 includes an additional functional impairment item that assesses how much the problems have affected the respondents' daily activities. The scale has shown strong psychometric properties across diverse populations. Among U.S. older adults, the PHQ-9 showed high sensitivity (88%) and specificity (80%) for identifying major depression, as well as the combination of major and minor depression (Phelan et al., 2010).

  Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up

• Short Form Health Survey (SF-12)

  The Short Form Health Survey (SF-12) is a self-reported outcome measure to assess health-related quality of life. The raw answers from the 12 questions are processed to produce two main, standardized summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). We only used the MCS factor in this study as the treatment is targeting mental health. The MCS computed score has a range from 17 to 64 in the analysis and was based on the linear combination of six computed, generated, iterated weights. A low Mental Component Summary (MCS) score indicates poorer self-perceived mental health and lower health-related quality of life.

  Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up

• Interpersonal Needs Questionnaire (INQ-15)

  The Interpersonal Needs Questionnaire (INQ; Van Orden et al., 2012) was used to evaluate thwarted belongingness and perceived burdensomeness through 15 items. An adapted version tailored specifically for older adults was used which includes 3-point Likert scale ranging from 1 (Not at all true for me) to 3 (Very true for me). The instrument includes 2 sets of characteristics: (1) the 9-item Thwarted Belongingness (e.g., "I feel disconnected from other people."); and (2) the 6-item Perceived Burdensomeness (e.g., "I think my death would be a relief to the people in my life."). Six questions from the Thwarted Belongingness subscale were reverse-coded when the overall score across questions was computed due to the nature of those questions. In particular, the total score on the INQ is calculated by summing the questions responses to all items and reversing the appropriate ones. As a result, greater scores on each subscale reflect higher levels of the respective construct being measured.

  Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up

• Implementation Science Sustainability Survey Measures: AIM

  AIM: The Affect Intensity Measure is a 40-item, self-report questionnaire used in psychology to determine the characteristic strength or weakness with which an individual experiences both positive and negative emotions.4-item instrument measuring the acceptability of an intervention. Item Scale: Each of the 4 items is rated on a 5-point Likert scale, typically ranging from 1 (Completely Disagree) to 5 (Completely Agree). Calculation: The final score is the mean (average) of the four individual item scores. Interpretation: Higher average scores indicate greater perceived acceptability of the intervention among the respondents.

  Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up

• Implementation Science Sustainability Survey Measures: IAM

  IAM: The Intervention Appropriateness Measure (IAM) is a 4-item survey used in implementation science to assess the perceived suitability or relevance of a healthcare intervention or implementation strategy. Item Scale: Each of the 4 items is rated on a 5-point Likert scale, typically ranging from 1 (Completely Disagree) to 5 (Completely Agree). Average Item Rating: To find the average for a specific item, sum the scores from all respondents and divide by the total number of respondents. Aggregate Score: To calculate the overall IAM score for an individual or group, take the mean (average) of the four items. Interpretation: Higher average scores indicate that stakeholders perceive the intervention as more appropriate, fitting, or relevant to their specific setting or population.

  Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up

• Implementation Science Sustainability Survey Measures: FIM

  FIM: The Functional Independence Measure (FIM) is a standardized assessment tool used primarily in rehabilitation to measure a patient's level of disability and the amount of assistance they require for daily activities. Item Scale: Each of the 4 items is rated on a 5-point Likert scale, typically ranging from 1 (Completely Disagree) to 5 (Completely Agree). Final Score: Sum the scores of all 4 items and divide by 4 to get the individual respondent's mean score. Interpretation: Higher scores (closer to 5) indicate that the intervention is perceived as more feasible, "doable," or "possible". There are currently no established "cut-off" scores; results are typically compared across different time points or groups.

  Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up

• Implementation Science Sustainability Survey Measures: SUS

  SUS: The system Usability Scale is a 10-item measure of digital intervention usability. Items are scored on a 5-item Likert scale (Strongly Disagree-Strongly Agree). Convert these raw ratings into a "score contribution" for each item: Odd-numbered items (1, 3, 5, 7, 9): Subtract 1 from the raw user response (i.e. X-1) Even-numbered items (2, 4, 6, 8, 10): Subtract the raw user response from 5 (i.e. 5-X) Result: Every item will now have a value between 0 and 4. Aggregate Calculation: Sum the Scores: Add all 10 converted item scores together. This will result in a total between 0 and 40. Then multiply this sum by 2.5. This step scales the total from a 40-point maximum to a 100-point maximum. Interpretation of Results: The final SUS score is a measure of perceived usability, not a percentage. Generally, the following benchmarks apply: Score \< 51: Often considered "poor" or "unaccepta

  Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up

• Household Food Security Survey Module - 10 item (Adult Only)

  The Household Food Security Survey Module (HFSSM) is the primary, validated survey tool used to measure the prevalence and severity of food insecurity in the United States and other countries like Canada. The Household Food Security Survey Module (HFSSM) is scored by calculating a raw score based on the number of affirmative responses to its questions. This raw score is then used to classify households into specific food security categories. 0 affirmative responses = High Food Security 1-2 affirmative responses = Marginal Food Security 3-5 affirmative responses = Low Food Security 6-10 affirmative responses = Very Low Food Security

  Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up

Secondary Outcomes (2)

• Session Rating Scale

  Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up

• Consolidated Framework for Implementation Science (CFIR) Interview Guide Tool

  Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up

Study Arms (3)

BE condition

EXPERIMENTAL

BE condition which involves receiving call dosages from providers trained to foster belongingness and empathy (2 hours), grounded in the befriending literature35,36, and narrative reminiscence37. Aging Network Providers trained in BE provide a "small dose of sincere connection", through narrative reminiscence, and the "befriending" strategies. While the majority of the warm calling of BE WITH centers on this basic connections intervention, there is a brief module on suicide risk. While this basic "reciprocally caring relationships" treatment will be enough for the majority of participants, there will also be individuals who need more than connection, but rather targeted suicide intervention as approximately 20% of older adults receiving home and community-based services are at risk of suicide38.

Behavioral: Standardized and manualized warm calls from providers trained in the BE training

BE + ASIST condition

EXPERIMENTAL

BE + ASIST condition includes receiving call dosages from providers trained in BE + the aging variant of LivingWorks ASIST (Applied Suicide Intervention Skills Training)40. Those older adults assigned to this treatment condition will have both the connections intervention, as well as suicide interventions in the chance that a suicide intervention is needed.

Behavioral: Standardized and manualized warm calls from providers trained in the BE training + ASIST training

Control

NO INTERVENTION

Control group includes no treatment, or call dosages during the 8 weeks. Every two weeks graduate research students administer the measure set, just as they did for the 2 treatment conditions. However, after the 8 weeks, these older adult participants have the opportunity to receive the call dosages (delayed waitlist control).

Interventions

Standardized and manualized warm calls from providers trained in the BE training + ASIST training BEHAVIORAL

Weekly call dosages averaging 20-30 minutes each, for 8 weeks duration; with a 6 month follow up.

BE + ASIST condition

Standardized and manualized warm calls from providers trained in the BE training BEHAVIORAL

Weekly call dosages averaging 20-30 minutes each, for 8 weeks duration; with a 6 month follow up.

BE condition

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• University of Florida: lead
• University of Louisiana at Lafayette: collaborator
• Virginia Polytechnic Institute and State University: collaborator
• Georgia State University: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being; Depression; Social Adjustment; Suicidal Ideation

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Behavioral Symptoms; Social Behavior; Suicide; Self-Injurious Behavior

Central Study Contacts

Laura R Shannonhouse, PhD

CONTACT

352-273-4332; lshannonhouse@coe.ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Methodologist
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: March 16, 2026
• Study Start: September 5, 2025
• Primary Completion (Estimated): August 30, 2030
• Study Completion (Estimated): August 30, 2030
• Last Updated: March 16, 2026

Record last verified: 2025-11

Locations

US (1)