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NCT Number: NCT06444308

Community Health Worker-led Hypertension Management

This study is to determine if hypertension management by community health workers (CHW) supported by a mobile health application and remote physician supervision is non-inferior to management by a physician for the primary outcome of improvement in systolic blood pressure. The target population is patients with hypertension in rural Guatemala. Study duration will be 12-24 months.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Community

San Lucas Tolimán, Guatemala

Location status: Recruiting

About this study

The investigators have developed an innovative system of care utilizing CHWs equipped with a mobile application and supported and supervised remotely by physicians. This model of care is adapted from a CHW-led diabetes program enabled by a similar CDS application which the investigators implemented in the same communities in rural Guatemala where we will carry out this proposed study. This program safely led to significant improvements in glycemic control. The mobile application is built on the widely-used CommCare platform and provides clinical decision support (CDS) to CHWs based on protocols from the WHO and the International Society of Hypertension for antihypertensive medication initiation and titration, lifestyle counseling, and identification of patients requiring a higher level of care.

The Primary Objective is to determine if hypertension management by CHWs is non-inferior to care provided directly by a physician.

The Secondary Objective is to evaluate the safety, acceptability to patients, and cost of CHW-led care compared to care provided directly by a physician.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults age 18 or greater with diagnosis of hypertension AND blood pressure (BP) greater than or equal to 140/90 OR currently taking antihypertensive medication.
  • Ability to provide informed consent

Exclusion criteria

  • Pregnancy
  • Severe comorbid condition(s) with life expectancy less than 1 year

Treatment and study plan

CommCare with Mobile Clinical Decision Support (CDS) Application

Other

For those assigned to the CHW arm, management will be assisted by CDS from the CommCare application.

Remote Supervision by Physicians

Other

teleconsultation with a supervising physician

CommCare Application without CDS

Other

The physician will have received training and orientation on the same clinical protocols followed by the CHWs, as well as access to reference materials for these protocols, but the version of the CommCare application used will not provide CDS, but will serve to record and review patient data only.

Primary outcomes

  1. Change in Systolic Blood Pressure (SBP)

    Time frame: Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)

Secondary outcomes

  1. Proportion of Participants with SBP less than 140mmHg

    Time frame: Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)

  2. Proportion of Participants with SBP less than their personalized goal

    Time frame: Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)

  3. Change in Diastolic Blood Pressure (DBP)

    Time frame: Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)

  4. Change in Hemoglobin A1c (HbA1c)

    Time frame: Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)

  5. Change in Diabetes Control

    Time frame: Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)

    Indicated by the proportion of diabetic patients with HbA1c less than 8 and the proportion of diabetic patients with HbA1c less than their personalized goal.

  6. Change in Weight

    Time frame: Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)

  7. Change in Total Cholesterol

    Time frame: Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)

  8. Change in LDL Cholesterol

    Time frame: Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)

  9. Change in HDL Cholesterol

    Time frame: Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)

  10. Change in Triglycerides

    Time frame: Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)

  11. Change in Creatinine

    Time frame: Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)

  12. Change in Estimated Glomerular Filtration Rate (eGFR)

    Time frame: Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)

  13. Change in 10 year CVD risk (per WHO risk prediction charts)

    Time frame: Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)

  14. Change in Hypertension Self-Care Activity Level Effects (H-SCALE): Medication Adherence Subscale Score

    Time frame: Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)

    The H-SCALE: Medication Adherence subscale is scored from 0-21 where higher scores indicate a more positive attitude toward adherence.

  15. Change in H-SCALE: Weight Management Score

    Time frame: Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)

    The H-SCALE: Weight Management subscale is scored from 9-45 where higher scores indicate a more positive attitude toward weight management.

  16. Change in H-SCALE: Physical Exercise Score

    Time frame: Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)

    The H-SCALE: Physical Exercise subscale is scored from 0-14 where higher scores indicate a more positive behavior toward physical exercise.

  17. Change in H-SCALE: Smoking Exposure Score

    Time frame: Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)

    The H-SCALE: Smoking Exposure subscale is scored from 0-14 where a score of 0 indicates a more positive attitude toward smoking exposure.

  18. Change in H-SCALE: Alcohol Intake Score

    Time frame: Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)

    The H-SCALE: Alcohol Intake subscale contains three questions and is scored as abstainer (does not drink) or non-adherent (reported drinking alcohol).

  19. Change in H-SCALE: Healthy Eating Plan Score

    Time frame: Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)

    The H-SCALE: Healthy Eating Plan subscale is scored from 0-70 where higher scores indicate a more positive attitude toward healthy eating.

  20. Change in selected items from the Patient Assessment of Chronic Illness Care (PACIC) survey

    Time frame: Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)

    PACIC will be scored on a likert scale from 1-5 (almost never to almost always) where higher scores indicate better assessment of chronic illness care.

  21. Change in global hypertension care satisfaction score

    Time frame: Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)

    Scored from 1-5 where higher scores indicate less satisfaction with hypertension care.

  22. Change in pill count adherence ratio (PCAR)

    Time frame: Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)

    PCAR is the total number of doses dispensed less that total doses missed divided by the total doses dispensed.

  23. Change in self-reported adherence

    Time frame: Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)

    Self-reported adherence is rated on a five point scale of how often patients are taking their medications as directed, from "less than half the time" to "100% of the time".

  24. Proportion of lifestyle knowledge questions answered correctly

    Time frame: through study completion, an average of 12 months

    The proportion of a set of true-false or multiple choice questions developed for this study to assess hypertension-related lifestyle knowledge answered correctly

Other outcomes

  1. Participant retention at 6 and 12 months

    Time frame: 6 months, 12 months

  2. Proportion of possible study visits completed at 6 and 12 months

    Time frame: 6 months, 12 months

  3. Mean duration of study visits

    Time frame: up to 24 months

  4. Mean duration of physician review and care coordination time per patient encounter

    Time frame: up to 24 months

  5. Comparison of antihypertensive medications prescribed and dosages

    Time frame: up to 24 months

  6. Proportion of patients with an indication taking aspirin

    Time frame: up to 24 months

  7. Proportion of patients taking two or more antihypertensives

    Time frame: up to 24 months

  8. Estimated cost of care

    Time frame: up to 24 months

Study contacts

Contact information is provided by the study sponsor or research team.

Sean Duffy, MD

CONTACT

[email protected]

608-354-7930

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • Fogarty International Center of the National Institute of Health

Registry information

Official study title

Assessing the Efficacy and Safety of Community Health Worker-led Hypertension Management Enabled by a Mobile Clinical Decision Support Application Compared to Physician Care: a Randomized, Controlled, Noninferiority Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 5, 2024
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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