Project HOPEFUL (Helping Older PErsons Find Useful Links): Replicating a Partially Nested Randomized Control Trial With Implementation Science
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Social Provisions Scale (SPS-5)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Methodologist
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
BE condition
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.
干预措施: Standardized and manualized warm calls from providers trained in the BE training (Behavioral)
BE + ASIST condition
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.
干预措施: Standardized and manualized warm calls from providers trained in the BE training + ASIST training (Behavioral)
Control
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).
结局指标
主要结局
Social Provisions Scale (SPS-5)
时间窗: Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up
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.
University of California, Los Angeles Loneliness Scale
时间窗: Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up
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.
Patient Health Questionnaire - PHQ-9
时间窗: Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up
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).
Short Form Health Survey (SF-12)
时间窗: Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up
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.
Interpersonal Needs Questionnaire (INQ-15)
时间窗: Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up
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.
Implementation Science Sustainability Survey Measures: AIM
时间窗: Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up
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.
Implementation Science Sustainability Survey Measures: IAM
时间窗: Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up
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.
Implementation Science Sustainability Survey Measures: FIM
时间窗: Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up
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.
Implementation Science Sustainability Survey Measures: SUS
时间窗: Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up
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
Household Food Security Survey Module - 10 item (Adult Only)
时间窗: Baseline; 2 weeks, 4 weeks, 6 weeks, 8 weeks; 6 month follow up
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
次要结局
- 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)