El Corazon de La Comunidad Study - The Purpose of This Research Study is to Develop, Implement, and Evaluate a Community-based Approach to Bolstering the Health and Efficacy of Community Service Providers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Impact of Intervention on Heart Rate Variability
研究概览
简要总结
Community service providers (CSPs), such as promotores and other community health staff, play an essential role in preserving health and treating disease in underserved Hispanic/Latinx (HL) communities with disproportionately high rates of cardiometabolic (CM) disease. Although effective programs have been developed that deploy CSPs to reduce CM disease risk in the community, to our knowledge no interventions have sought to reduce CM risk among CSPs themselves. However, CSPs are also at high risk for adverse CM outcomes, as they have the same high-risk demographics as the communities they serve and they work in high-stress, frontline jobs. Reducing CM risk among HL CSPs is crucial to promote health at both the individual and community levels; that is, preventive interventions delivered to CSPs may not only promote the health of the individual CSPs who receive the intervention but also may bolster CSPs to more effectively deliver programming that protects CM health community-wide. The proposed study employs relational savoring (RS), a brief intervention rooted in positive psychology and attachment, which has previously been shown to promote psychosocial well-being and which is particularly efficacious in HL populations. Emerging research supports that RS may also promote more optimal cardiovascular regulation and health behavior. Therefore, the investigators deliver RS to CSPs in order to identify CM health protective effects for both CSPs and the high-risk communities they serve.
Aims and Hypotheses:
Aim 1: Examine effects of RS on CSPs' CM risk factors and outcomes. Hypotheses: RS (compared to wait-list control) will be associated with lower CM risk, as indexed by higher mean HRV, both during a stressor and at rest (H1A). RS will also be associated with a more favorable CM health behavior profile, indexed by higher quality sleep, more exercise, and healthier diet (H1B). Aim 2: Examine effects of RS on CSPs' delivery of CM health programming to the community. Hypotheses: RS will be associated both with reduced threats to CSPs leaving the workforce, including higher satisfaction with work, greater agency, and lower burnout (H2A), and with a higher number of community members reached for CM health programming, as indexed by number of days CSP worked, number of health-related events offered by CSPs, community attendance at events, and retention of community members across multi-day programs (H2B).
详细描述
Although HL Americans face higher CM risk than do non-Hispanic white Americans, they have markedly lower access to healthcare. CSPs, including promotores and frontline community health staff, are community members who serve as hubs of health services provision within low-income HL communities and are critical conduits of the information, support, and care needed to prevent and manage CM disease. Yet as members of the low-income HL communities they serve, CSPs are at risk for the same negative health outcomes as those they support. This risk is amplified by the enormous stress the COVID-19 pandemic has wrought on frontline healthcare workers, such as CSPs. Employment in frontline health work during COVID-19 has been associated with psychological distress, including anxiety, depression, insomnia, and burnout; major and chronic stress, and work stress in particular, in turn, is associated with higher rates of CM disease. Therefore, CPSs are doubly at risk, from both their demographics and their occupation. However, to our knowledge, no intervention programs have been designed to protect CM health among CSPs specifically.
When CSP's health and wellbeing is at risk, the CM health of the larger community hangs in the balance. CSP-led community interventions, such as diabetes and obesity prevention programs, have proven effective, affordable, and well-received in reducing CM risk factors in the community, such as A1c, blood pressure, LDL cholesterol, triglycerides, insulin, sedentary behavior, and overweight. However, the COVID- 19 pandemic has endangered CSPs' abilities to deliver these important programs by placing tremendous demand on CSPs, contributing to professional burnout. Fortifying CSPs to effectively deliver crucial health programming despite enormous contextual burdens may have cascading effects on the CM health of HL communities. In strengthening CSPs that serve low income HL communities, not only does the intervention reduce the risk experienced by the CSPs themselves, but the investigation also stand to strengthen the entire HL community, by investing in the people who disseminate interventions to the community. Thus, brief interventions are needed for CSPs to protect health and to reduce risk factors that may interrupt service delivery to the community, such as burn-out in the face of environmental stress, in order to protect CM health for both CSPs and the communities they serve. Moreover, our community partner, Latino Health Access (LHA), identified programs to support the health and wellbeing of CSPs using a "mind-body approach" as a top priority for their agency.
Relational savoring (RS) is a brief intervention grounded in positive psychology and attachment theory that involves reflecting deeply on a positive emotional experience occurring with another person. The central premise underlying RS is that focusing deeply on moments of positive connection helps to augment the positive emotion and meaning the participants derive from positive interpersonal experiences, in order to enhance fulfillment and satisfaction, resolve distress, and increase one's sense of psychological agency. RS involves recalling a time when one supported or comforted another person and doing so brought deep positive emotion (joy, satisfaction, love, or peace); these moments of connection in service of another are common among the CSPs who work for our community agency, but may go unnoticed in the face of the urgent stressors the COVID-19 pandemic has brought about. Prolonging and enhancing attention to these moments has the potential to both help CSPs restore regulation in the face of stress and to motivate CSPs to continue engaging in meaningful work that serves their communities. RS is a one-on-one intervention that can be led by interveners with minimal training (e.g., undergraduates, promotores) to a high level of fidelity and delivered in brief sessions (30 minutes). Interveners help participants identify a connected memory, then lead participants through a 5-step reflection process that involves deeply focusing on different aspects of the memory. To date, RS has been tested among parents, long-distance partners, military partners during a deployment, older adults, and people in residential psychiatric treatment. RS is particularly effective among HL populations, perhaps because of its congruence with HL values such as simpatía and familismo. RS shows tremendous promise in improving psychological indicators of well-being, including more optimal emotional state, greater relationship satisfaction, interactional quality, and greater psychological agency. Early data support that RS may also shape mechanisms underlying physical health, as RS enhances both health behavior (greater adherence to safety measures during COVID-19) and cardiovascular regulation (lower heart rate while completing RS than while savoring an individual experience). However, RS has yet to be linked with CM health behaviors, such as physical activity, or with CM disease markers, such as heart rate variability (HRV), a non-invasive measure of parasympathetic activity which is linked with CM morbidity and mortality.
Utility of targeting CM disease risk markers through psychosocial interventions:
HRV is a robust predictor of CM health. Lower HRV predicts cardiovascular disease, including first cardiovascular events, even in populations without known CVD. Additionally, lower HRV is associated with higher glucose and A1c among diabetes patients. HRV plays a critical role in regulating allostatic systems that mediate CM disease processes, such as glucose regulation, hypothalamic-pituitary adrenal axis functioning, and inflammation. Not only do HRV and health behaviors precede the onset of full-blown CM disease, but, critically, HRV is responsive to changes in psychosocial conditions, serving as a bridge between psychosocial regulatory processes, such as emotion regulation, and health-related physiological processes, such as allostatic wear-and- tear to CM systems. Similarly, health behaviors, such as physical activity, diet, and sleep, have robust downstream effects on CM health and are responsive to psychosocial intervention. Therefore, establishing psychosocial interventions that influence HRV and health behavior have tremendous potential to protect CM health for at-risk populations before full-blown disease develops.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for participants includes being an employee at one of the community health agencies serving low income HL families that we are partnered with (Latino Health Access in Santa Ana or Ser Familia in Atlanta).
排除标准
- •Not being an employee at one of the community health agencies involved in the study.
研究组 & 干预措施
Intervention Group
In this randomized controlled waitlist design, following a baseline assessment, we will randomly assign CSPs into the experimental group (n = 40) or a waitlist group (n = 40). The experimental group will receive the intervention immediately, whereas the waitlist control will wait 4 weeks and have a second baseline assessment before receiving the intervention. All participants will complete an identical assessment battery at pre-intervention baseline, immediately post-intervention, and 3-months following the intervention.
干预措施: Relational Savoring Intervention (Behavioral)
Waitlist Control Group
In this randomized controlled waitlist design, following a baseline assessment, we will randomly assign CSPs into the experimental group (n = 40) or a waitlist group (n = 40). The experimental group will receive the intervention immediately, whereas the waitlist control will wait 4 weeks and have a second baseline assessment before receiving the intervention. All participants will complete an identical assessment battery at pre-intervention baseline, immediately post-intervention, and 3-months following the intervention.
干预措施: Relational Savoring Intervention (Behavioral)
结局指标
主要结局
Impact of Intervention on Heart Rate Variability
时间窗: Assessed at Baseline 1 for both groups and 4 weeks later (post-intervention for intervention participants and Baseline 2 for waitlist control participants). Post-intervention data were not collected for the waitlist control group.
Cardiovascular health was assessed using heart rate variability (HRV) measured during a socially relevant stressor task administered in each intervention session. HRV data were collected using the movisens device, a wearable chest-mounted sensor that records electrocardiogram (ECG) data. Vagally mediated HRV was calculated from the variability of inter-beat (R-R) intervals derived from these ECG recordings. Mean HRV values were calculated for each assessment period, with higher mean HRV values (per minute) indicating greater autonomic regulation and improved cardiovascular health. Due to feasibility and data quality issues with the wearable ECG device, HRV data collection was discontinued after the first two assessment periods (Baseline 1 and the 4-week assessment \[post-intervention for the intervention group/Baseline 2 for the waitlist control group\]); therefore, post-intervention HRV data were not collected for the waitlist control group.
Acceptability of the Relational Savoring Intervention
时间窗: Immediately following completion of the 4-week intervention and at 3 months post-intervention.
Intervention acceptability was assessed using participant self-report items evaluating frequency of use of the intervention skills, perceived value of the intervention, willingness to recommend the intervention to others, and intention to continue engaging in the intervention skills. Acceptability was assessed only after completion of the intervention and at the 3-month follow-up. Acceptability scores were summarized using mean scores reported separately at post-intervention and at the 3-month follow-up across the sample. Possible scores ranged from 0 to 30, with higher scores indicating greater acceptability.
Impact of Intervention on Perceived Closeness to the Community
时间窗: Immediately before and after each weekly intervention session (Sessions 1-4, approximately 1 hour apart per session), during the 4-week intervention period.
Perceived closeness to community was assessed using the Inclusion of Other in the Self-Community Version (IOS-C), a single-item visual self-report measure. Participants selected one of seven images depicting increasing overlap between two circles representing the self and the community. Greater overlap indicates greater perceived closeness to the community, whereas less overlap indicates lower perceived closeness. The measure was administered immediately before and after each intervention session (four sessions total). Scores ranged from 1 (not close at all) to 7 (very close), with higher scores indicating greater perceived closeness to the community.
Impact of Intervention on Negative Emotional Valence
时间窗: Immediately before and after each weekly intervention session (Sessions 1-4, approximately 1 hour apart per session), during the 4-week intervention period.
Emotional valence was assessed using the valence subscale of the Self-Assessment Manikin (SAM), a nonverbal pictorial self-report measure. Participants selected one of five pictograms ranging from smiling to frowning to indicate their current emotional state. Scores ranged from 1 to 5, with lower scores indicating more positive emotional valence and higher scores indicating more negative emotional valence. The measure was administered immediately before and after each intervention session.
Impact of Intervention on Sleep Quality
时间窗: Baseline (prior to intervention), immediately following completion of the 4-week intervention, and at 3 months post-intervention.
Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), a 19-item self-report questionnaire that assesses subjective sleep quality over the past month. The PSQI yields a global sleep quality score derived from seven component scores, with total scores ranging from 0 to 21. Higher scores indicate poorer sleep quality.
Impact of Intervention on Diet
时间窗: Baseline (prior to intervention), immediately following completion of the 4-week intervention, and at 3 months post-intervention.
can you revise to make it clear that scoring was dichotomized as ither true or false and thus scores ranged from: Changes in diet-related behavior were assessed using the Emotional Eating subscale of the Three-Factor Eating Questionnaire (TFEQ). The subscale consists of 3 items assessing the extent to which individuals eat in response to emotional states. Items are rated on a 4-point scale ranging from 0 (definitely true) to 3 (definitely false). Item responses were summed to create a total emotional eating score ranging from 0 to 9, with lower scores indicating greater emotional eating and higher scores indicating less emotional eating.
Impact of Intervention on Burnout
时间窗: From baseline (prior to intervention), immediately following completion of the 4-week intervention, and at 3 months post-intervention.
Burnout related to the COVID-19 pandemic was assessed using the COVID-19 Burnout Scale, a 10-item self-report measure. Items assess feelings of emotional exhaustion and hopelessness related to the pandemic and are rated on a 7-point scale ranging from 0 (never) to 6 (all the time). Item responses are summed to create a total burnout score ranging from 0 to 60, with higher scores indicating greater burnout. The measure was administered at baseline (1 and 2), post-intervention, and at the 3-month follow-up.
Impact of Intervention on Job Satisfaction
时间窗: From baseline (prior to intervention), immediately following completion of the 4-week intervention, and at 3 months post-intervention.
Job satisfaction was assessed using the Job Satisfaction Scale, a 36-item self-report questionnaire measuring participants' overall attitudes toward their job. Items were rated on a 6-point Likert-type scale ranging from 1 (disagree very much) to 6 (agree very much). Item responses were summed to create a total job satisfaction score ranging from 36 to 216, with higher scores indicating greater job satisfaction. The measure was administered at baseline (1 and 2), post-intervention, and at the 3-month follow-up.
Impact of Intervention on Psychological Distress
时间窗: From baseline (prior to intervention), immediately following completion of the 4-week intervention, and at 3 months post-intervention.
Psychological distress was assessed using the Brief Symptom Inventory (BSI), a 19-item self-report measure assessing symptoms of depression, anxiety, and somatic distress. Items were rated on a 6-point scale ranging from 0 (not at all) to 5 (extremely). Item responses were summed to create a global psychological distress score ranging from 0 to 95, with higher scores indicating greater overall distress. The measure was administered at baseline (1 and 2), post-intervention, and at the 3-month follow-up.
Impact of Intervention on General Health
时间窗: From baseline (prior to intervention), immediately following completion of the 4-week intervention, and at 3 months post-intervention.
General health was assessed using the General Health subscale of the Short Form Health Survey (SF-36). Participants completed the full SF-36 questionnaire, and the 5 items comprising the General Health subscale were scored according to standard SF-36 procedures. Item responses were recoded and summed, and the raw subscale score was transformed to a 0-100 scale, with higher scores indicating better perceived physical health. The measure was administered at baseline (1 and 2), post-intervention, and at the 3-month follow-up.
Impact of Intervention on Community Outreach
时间窗: Baseline (prior to intervention), immediately following completion of the 4-week intervention, and at 3 months post-intervention.
Community outreach was assessed using a composite measure of community engagement and reach in community health programming. The composite index captured the extent to which community members were reached by community health programming and was calculated using four indicators: (1) number of days community service providers (CSPs) worked, (2) number of health-related events offered by CSPs, (3) community attendance at CSP-led events, and (4) retention of community members across multi-day programs. Indicators were combined to create a total community outreach score, with higher scores reflecting greater outreach and a higher number of community members reached through community health programming.
次要结局
未报告次要终点
研究者
Jessica Borelli
Professor
University of California, Irvine