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

7. juli 2026 opdateret af: Candace Robledo, University of Texas Rio Grande Valley

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

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

200

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • Texas
      • Edinburg, Texas, Forenede Stater, 78539
        • Rekruttering
        • The University of Texas at Rio Grande Valley
        • Kontakt:
          • Lindsey Simon, Assistant Director Regulatory Clinical Research
          • Telefonnummer: 9562968723
          • E-mail: lindsey.simon@utrgv.edu
        • Kontakt:
        • Ledende efterforsker:
          • Candace A Robledo, PhD, MPH
      • Houston, Texas, Forenede Stater, 77025
        • Rekruttering
        • CAN DO Houston
        • Kontakt:
        • Ledende efterforsker:
          • Jasmine J Opusunju, DrPH, MSEd

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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).
Adfærdsmæssigt: Conversations Advancing Resilience and Empowerment (CARE)
Health promotion intervention to address chronic disease risk
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Health-related Quality of Life
Tidsramme: 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.
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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Flawed information on nutrition, physical activity, blood pressure, and mental health
Tidsramme: 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.
Flawed information measures the increase in self-efficacy in evaluating health information (flawed information) and to prevent and/or manage chronic conditions, health promotion knowledge, intention to change behavior. Trust in health information sources is measured using 11 investigator-developed items assessing trust in healthcare providers, media, government agencies, community health workers, and community organizations. Responses are rated from 1 (Not at all) to 4 (A great deal), with a Does Not Apply option treated as missing. Item scores are averaged across rated items; higher scores indicate greater trust. Flawed nutrition, physical activity, blood pressure, and mental health information are measured using two likert-scale items rated from 1 (Strongly agree) to 5 (Strongly disagree). Items are reverse coded as needed so higher scores indicate lower endorsement of nutrition flawed information.
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
Tidsramme: 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
Nutrition knowledge is measured using investigator-developed multiple-choice items based on the USDA Dietary Guidelines for Americans. Correct responses receive one point; incorrect and "Don't know" responses receive zero points. Scores are summed, with higher scores indicating greater nutrition knowledge. Physical activity knowledge is measured using investigator-developed true/false and multiple-choice items informed by the Physical Activity Guidelines for Americans. Blood pressure knowledge is assessed using investigator-developed true/false and multiple-choice items based on American Heart Association recommendations. Correct responses receive one point; higher summed scores indicate greater knowledge. Knowledge of the relationship between sleep and mental health is measured using five investigator-developed true/false items informed by the CDC and Journal of Clinical Sleep Medicine. Higher summed scores indicate greater sleep-related knowledge.
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
Tidsramme: 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.
Nutrition, physical activity, blood pressure, and sleep attitudes and beliefs are measured using six different Theory of Planned Behavior-based (TPB) items rated 1-5 for each measure. Composite scale scores are created after reverse-coding any negatively worded items. Higher scores indicate more favorable attitudes and beliefs for each measure.
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
Tidsramme: 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
This survey variable is an adoption of preventative health behaviors. Smoking behavior is measured by current smoking status and average cigarettes smoked per day. Lower smoking frequency indicates healthier behavior. Nutrition behavior is measured by self-reported frequency of fruit, vegetable, sugar-sweetened beverage intake and stage of change. Higher healthy food intake and advanced stage indicate healthier behavior. Physical activity behavior is measured by activity frequency, minutes/week and stage of change. Higher activity and maintenance stage indicate healthier behavior. Blood pressure behavior is measured by stage of change and confidence checking blood pressure at home. Higher scores indicate greater engagement. Sleep behavior is measured by using a stage-of-change item for obtaining 7-9 hours of sleep. Higher stage indicates healthier sleep 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
Tidsramme: 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 outcome will be 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.
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
Tidsramme: 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 are measured by the number of essential social needs for food insecurity, increase in social support, increase in awareness of resources; using the USDA 2-item Food Insecurity Screener. Responses range from 'Often true' to 'Never true'. Higher affirmative responses indicate greater food insecurity.
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)
Tidsramme: 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
Blood pressure outcomes are assessed by changes in systolic and diastolic blood pressure, based on the average of two measurements obtained from the left arm using an electronic blood pressure monitor, with readings collected at least 60 seconds apart. Blood pressure is measured four times per week by the Community Health Worker (CHW) during the intervention period and is self-reported monthly for six months following the intervention.
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
Tidsramme: 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
Measured by our health assessment (CARE + CS4) using investigator-developed items assessing healthcare access, insurance, transportation, neighborhood environment, housing, employment and related factors. Variables are analyzed individually or grouped by domain as appropriate. All assessments are completed at baseline, end of intervention at 4-weeks, and the 3- and 6-month follow-up.
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
Tidsramme: 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.
Measures changes in Community Health Worker (CHW) knowledge, self-efficacy, skills, and beliefs related to implementation and delivery of the CARE intervention.
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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Texas Rio Grande Valley

Samarbejdspartnere

National Heart, Lung, and Blood Institute (NHLBI)
CAN DO Houston

Efterforskere

  • Ledende efterforsker: Candace A Robledo, PhD, MPH, The University of Texas at Rio Grande Valley
  • Ledende efterforsker: Jasmine J Opusunju, DrPH, MSEd, CAN DO Houston

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. juni 2026

Primær færdiggørelse (Anslået)

31. januar 2027

Studieafslutning (Anslået)

31. marts 2027

Datoer for studieregistrering

Først indsendt

16. juni 2026

Først indsendt, der opfyldte QC-kriterier

7. juli 2026

Først opslået (Faktiske)

13. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • IRB 26-0075

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Individual participant data (IPD) collected throughout the study and used in the primary and secondary analyses will be shared in de-identified form to protect participant confidentiality. The shared dataset will include variables necessary to reproduce the analyses and validate the study findings. The supporting documentation that will be provided includes, our Study Protocol, the Statistical Analysis Plan (SAP), Clinical Study Report (CSR), and analytic code used to generate the results. Data will be made available to qualified researchers upon reasonable request and review, in accordance with institutional policies, data use agreements, and applicable privacy and regulatory requirements.

IPD-delingstidsramme

De-identified individual participant data (IPD) and accompanying supporting documentation will be made available beginning 3 months after publication of the primary study results. The data will remain available for a period of up to 3 years following publication. Access during this time frame will be provided to qualified researchers upon reasonable request and completion of applicable review procedures, in accordance with institutional policies, data use agreements, and relevant regulatory requirements.

IPD-delingsadgangskriterier

Access to de-identified individual participant data (IPD) and supporting documentation will be granted to qualified researchers who submit a methodologically sound research proposal with analyses that are scientifically and ethically appropriate, and consistent with or complementary to the objectives of the original study. Proposed statistical methods must be clearly described and may be subject to review for rigor and feasibility.

All requests must include a formal application outlining the research objectives, analysis plan, and data requirements. Requests will be reviewed by the study's principal investigator and/or a designated data governance committee to ensure compliance with institutional policies, ethical standards, and applicable regulations.

Upon approval, data will be shared through a secure platform following execution of a data use agreement (DUA) that defines conditions for access, use, data protection, and publication.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

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