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

7. července 2026 aktualizováno: 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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

200

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

  • Spojené státy
    • Texas
      • Edinburg, Texas, Spojené státy, 78539
        • Nábor
        • The University of Texas at Rio Grande Valley
        • Kontakt:
          • Lindsey Simon, Assistant Director Regulatory Clinical Research
          • Telefonní číslo: 9562968723
          • E-mail: lindsey.simon@utrgv.edu
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Candace A Robledo, PhD, MPH
      • Houston, Texas, Spojené státy, 77025
        • Nábor
        • CAN DO Houston
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Jasmine J Opusunju, DrPH, MSEd

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ano

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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).
Behaviorální: Conversations Advancing Resilience and Empowerment (CARE)
Health promotion intervention to address chronic disease risk
Žádný zásah: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Health-related Quality of Life
Časové okno: 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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Flawed information on nutrition, physical activity, blood pressure, and mental health
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Texas Rio Grande Valley

Spolupracovníci

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

Vyšetřovatelé

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

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

2. června 2026

Primární dokončení (Odhadovaný)

31. ledna 2027

Dokončení studie (Odhadovaný)

31. března 2027

Termíny zápisu do studia

První předloženo

16. června 2026

První předloženo, které splnilo kritéria kontroly kvality

7. července 2026

První zveřejněno (Aktuální)

13. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

13. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

7. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • IRB 26-0075

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

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.

Časový rámec sdílení IPD

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.

Kritéria přístupu pro sdílení IPD

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.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • ANALYTIC_CODE
  • CSR

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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