A Randomized Control Trial of Conversations Advancing Resilience and Empowerment (CARE): A Peer-Led Intervention to Improve Health Among Communities in Texas
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Health-related Quality of Life
研究概览
简要总结
The investigators propose to implement and evaluate the effectiveness of the peer-led CARE Intervention designed to mitigate health differences among rural and low-income communities in Texas. This intervention leverages the expertise of Community Health Workers (CHWs) to empower rural and low-income communities, improving health outcomes through outreach, education, counseling, and social support.
详细描述
The investigators will employ a randomized controlled trial through which individual participants will be randomized to either the intervention or control group. Randomization will be achieved by employing a computer program containing a random number generator (e.g., R). Given the study will be conducted at two sites (Rio Grande Valley and Harris County), randomization and subsequent clinical trials will be conducted independently at each site for feasibility and practicability. Participants in the control group will receive no intervention, but will be invited to receive health education sessions after the follow-up period has ended at 6-months post intervention.
Trained interventionists (e.g., CHWs) will deliver the intervention across four in-person visits and provide verbal reinforcement using implementation scripts, evidence-based skills (e.g., motivational interviewing, protocol-based counseling, health education) to leverage opportunities during conversations with participants to address flawed information and provide accurate information about quality of life-wellness-mental health (Session #1), blood pressure (Session #2), nutrition (Session #3), and physical activity (Session #4). Interventionists will utilize their CARE facilitators guide with embedded scripts to address inaccurate information on quality of life-wellness-mental health, blood pressure, nutrition, and physical activity and gently challenge/provide accurate information and sources.
Throughout the study period, the participants will complete the CARE + CS4 survey online via a Qualtrics or REDcap link for both study arms at 4 (four) timepoints: baseline, post-intervention, 3 months after intervention, and 6 months after intervention. The CARE + CS4 survey is a153 item questionnaire that will evaluate Health-related Quality of Life; Flawed information, Health Knowledge, Attitudes, and Beliefs; Health Behavior (Measuring and monitoring blood pressure), physical activity, nutrition, sleep); Physical and Mental Wellbeing; Social Needs, and Healthcare Utilization among participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females between the ages of 18-49
- •Self-report at least one risk factor cardiovascular disease (e.g. high blood pressure, high cholesterol, diabetes, overweight, and family history of heart disease).
- •Reside in one of the priority communities will be eligible to participate in the study.
- •Meet minimum digital literacy criteria, defined as having a working and readily accessible email address and using a smart device daily for texting, calling, and checking email.
- •Priority communities for the South Texas site include Harris, Hidalgo, Cameron, Willacy, Starr, and Nueces counties plus surrounding coastal communities served by South Coastal AHEC.
排除标准
- •Those not meeting the inclusion criteria will not be eligible to participate
研究组 & 干预措施
CARE Intervention Arm
Participants will have up to 60 minute scripted health conversations with a Community Health Worker (CHW) across four visits to leverage opportunities during conversations to address flawed information and provide accurate information about quality of life, wellness, and mental health (Session #1); blood pressure (Session #2); nutrition (Session #3); and physical activity (Session #4).
干预措施: Conversations Advancing Resilience and Empowerment (CARE) (Behavioral)
CARE Control Arm
Participants in the control group will receive no intervention, but will be invited to participate in the intervention (health education sessions) after the 6-month follow-up period has been completed.
结局指标
主要结局
Health-related Quality of Life
时间窗: From Baseline, end of intervention (following completion of Health Education Session #4; the intervention was designed to last 4 weeks but may be extended due to scheduling considerations), 3 months post-intervention, 6 months post-intervention.
The health-related quality of life (HRQOL) is measured by a decrease in the number of total unhealthy days compared to the control group at baseline, end of intervention at 4-weeks, and the 3- and 6-month follow-ups. The assessment used to measure this outcome is the World Health Organization Quality-of-Life-Scale Brief version (WHOQOL-BREF). The items from this assessment are scored using a likert scale of 1-5, 1 being the worst and 5 being the best. The raw score is calculated for each facet and each domain. Both facets and domains are scored through a simple summation of each item in that scale. Each question contributes equally to the facet score and each facet contributes equally to the domain score. Since each facet has four items with response values of 1 through 5, the raw score for any facet must have a minimum value of 4 and a maximum value of 20. Community narratives can be powerful tools that increase health narratives and promote behavior change.
次要结局
- Flawed information on nutrition, physical activity, blood pressure, and mental health(From Baseline, end of intervention (following completion of Health Education Session #4; the intervention was designed to last 4 weeks but may be extended due to scheduling considerations), 3 months post-intervention, 6 months post-intervention.)
- Health knowledge on nutrition, physical activity, blood pressure, and mental health(From Baseline, end of intervention (following completion of Health Education Session #4; the intervention was designed to last 4 weeks but may be extended due to scheduling considerations), 3 months post-intervention, 6 months post-intervention)
- Attitudes and beliefs on nutrition, physical activity, blood pressure, and sleep(From Baseline, end of intervention (following completion of Health Education Session #4; the intervention was designed to last 4 weeks but may be extended due to scheduling considerations), 3 months post-intervention, 6 months post-intervention.)
- Health Behavior(Baseline, end of intervention (following completion of Health Education Session #4; the intervention was designed to last 4 weeks but may be extended due to scheduling considerations), 3 months post-intervention, 6 months post-intervention)
- Physical and Mental Wellbeing(Baseline, end of intervention (following completion of Health Education Session #4; the intervention was designed to last 4 weeks but may be extended due to scheduling considerations), 3 months post-intervention, 6 months post-intervention)
- Social Needs(Baseline, end of intervention (following completion of Health Education Session #4; the intervention was designed to last 4 weeks but may be extended due to scheduling considerations), 3 months post-intervention, 6 months post-intervention)
- Health Status (Blood pressure)(Baseline, end of intervention (following completion of Health Education Session #4; the intervention was designed to last 4 weeks but may be extended due to scheduling considerations), 3 months post-intervention, 6 months post-intervention)
- Healthcare Utilization(Baseline, end of intervention (following completion of Health Education Session #4; the intervention was designed to last 4 weeks but may be extended due to scheduling considerations), 3 months post-intervention, 6 months post-intervention)
- Community Health Workers (CHW) Knowledge, Self-Efficacy, Skill Development, Beliefs(Baseline, end of intervention (following completion of Health Education Session #4; the intervention was designed to last 4 weeks but may be extended due to scheduling considerations), 3 months post-intervention, 6 months post-intervention.)
研究者
Candace Robledo
Associate Professor/Division Chief of Population Health & Biostatistics
University of Texas Rio Grande Valley