A Randomized Control Trial of Conversations Advancing Resilience and Empowerment (CARE) Intervention
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Conversations Advancing Resilience and Empowerment (CARE).
- Who it may be relevant to
- Registry conditions: Quality of Life, Health Promotion, Blood Pressure Monitoring, Self. Basic parameters: 18 years — 49 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Control Trial of Conversations Advancing Resilience and Empowerment (CARE): A Peer-Led Intervention to Improve Health Among Communities in Texas
Overview
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.
Detailed description
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.
Interventions
- Behavioral Conversations Advancing Resilience and Empowerment (CARE)
Health promotion intervention to address chronic disease risk
Primary outcome measures
- Health-related Quality of Life [Time frame: 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.]
Secondary outcome measures (9)
- Flawed information on nutrition, physical activity, blood pressure, and mental health [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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) [Time frame: 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 [Time frame: 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 [Time frame: 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.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Those not meeting the inclusion criteria will not be eligible to participate
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
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 2 centers
- The University of Texas at Rio Grande Valley — Edinburg
- CAN DO Houston — Houston
Identifiers
NCT: NCT07698964 · IRB 26-0075