Clinical trial NCT06444308: Community Health Worker-led Hypertension Management
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: community health worker
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Fogarty International Center of the National Institute of Health
First posted: 2024-06-05
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: cluster randomized, controlled, non-inferiority trial, each of 15 clusters of geographically grouped communities in the San Lucas Toliman municipality of Guatemala will be randomized to either CHW or physician care
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Systolic Blood Pressure (SBP)
timeFrame: Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
Secondary outcomes:
measure: Proportion of Participants with SBP less than 140mmHg
timeFrame: Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
measure: Proportion of Participants with SBP less than their personalized goal
timeFrame: Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
measure: Change in Diastolic Blood Pressure (DBP)
timeFrame: Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
measure: Change in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
measure: Change in Diabetes Control
timeFrame: Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
measure: Change in Weight
timeFrame: Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
measure: Change in Total Cholesterol
timeFrame: Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
measure: Change in LDL Cholesterol
timeFrame: Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
measure: Change in HDL Cholesterol
timeFrame: Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
measure: Change in Triglycerides
timeFrame: Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
measure: Change in Creatinine
timeFrame: Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
measure: Change in Estimated Glomerular Filtration Rate (eGFR)
timeFrame: Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
measure: Change in 10 year CVD risk (per WHO risk prediction charts)
timeFrame: Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
measure: Change in Hypertension Self-Care Activity Level Effects (H-SCALE): Medication Adherence Subscale Score
timeFrame: Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
measure: Change in H-SCALE: Weight Management Score
timeFrame: Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
measure: Change in H-SCALE: Physical Exercise Score
timeFrame: Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
measure: Change in H-SCALE: Smoking Exposure Score
timeFrame: Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
measure: Change in H-SCALE: Alcohol Intake Score
timeFrame: Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
measure: Change in H-SCALE: Healthy Eating Plan Score
timeFrame: Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
measure: Change in selected items from the Patient Assessment of Chronic Illness Care (PACIC) survey
timeFrame: Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
measure: Change in global hypertension care satisfaction score
timeFrame: Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
measure: Change in pill count adherence ratio (PCAR)
timeFrame: Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
measure: Change in self-reported adherence
timeFrame: Baseline, 6 months, 12 months (all participants assessed to 12 months, but participants on study early may also be assessed at 18 and 24 months)
measure: Proportion of lifestyle knowledge questions answered correctly
timeFrame: through study completion, an average of 12 months
Other outcomes:
measure: Participant retention at 6 and 12 months
timeFrame: 6 months, 12 months
measure: Proportion of possible study visits completed at 6 and 12 months
timeFrame: 6 months, 12 months
measure: Mean duration of study visits
timeFrame: up to 24 months
measure: Mean duration of physician review and care coordination time per patient encounter
timeFrame: up to 24 months
measure: Comparison of antihypertensive medications prescribed and dosages
timeFrame: up to 24 months
measure: Proportion of patients with an indication taking aspirin
timeFrame: up to 24 months
measure: Proportion of patients taking two or more antihypertensives
timeFrame: up to 24 months
measure: Estimated cost of care
timeFrame: up to 24 months
Locations:
city: San Lucas Tolimán
country: Guatemala
facility: Community
Study officials:
affiliation: University of Wisconsin, Madison
name: Sean Duffy, MD
role: PRINCIPAL_INVESTIGATOR
References: