A Randomized Control Trial of Conversations Advancing Resilience and Empowerment (CARE) Intervention

ClinicalTrials.gov ID

NCT07698964

Lead Sponsor

University of Texas Rio Grande ValleyOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

200Estimated

Last Update Posted

Jul 13, 2026Actual

Start Date

Jun 2, 2026Actual

Primary Completion Date

Jan 31, 2027Estimated

Completion Date

Mar 31, 2027Estimated

Official Title

A Randomized Control Trial of Conversations Advancing Resilience and Empowerment (CARE): A Peer-Led Intervention to Improve Health Among Communities in Texas

Brief Summary

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.

• Quality of Life
• Health Promotion
• Blood Pressure Monitoring, Self

• Conversations Advancing Resilience and Empowerment (CARE)

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

Yes

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

Primary Purpose

Prevention

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

University of Texas Rio Grande ValleyOTHER

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)NIH

CAN DO HoustonUNKNOWN

jasmine.opusunju@candohouston.org832-405-5451

• Hybrid Type I Effectiveness-implementation Cluster Randomized Controlled Trial of CARES

  NCT07183527

  RecruitingInterventionalNot ApplicableUpdated Aug 10, 2026
• Supporting Health in Veterans With Heart Failure

  NCT05839067

  RecruitingInterventionalNot ApplicableUpdated Nov 13, 2025
• WE-CARE Community Health Forums to Increase Breast Cancer Screening and Clinical Trial Participation for Rural and Low Income Women

  NCT07644702

  RecruitingInterventionalNot ApplicableUpdated Jun 12, 2026
• Social Needs Screening and Chronic Diseases Study (WE CARE)

  NCT06903897

  RecruitingInterventionalNot ApplicableUpdated May 22, 2026
• Improving Care for Rural Patients With Solid Tumors

  NCT04916990

  RecruitingInterventionalNot ApplicableUpdated Feb 5, 2026
• Connecting Healthy Women: Examining the Effect of an Intervention From the Effect of Being Reachable

  NCT02157168

  CompletedInterventionalNot ApplicableUpdated Apr 5, 2019