Community Health Worker-led Hypertension Management
ConditionHypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Wisconsin, Madison
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Pregnancy
Severe comorbid condition(s) with life expectancy less than 1 year
Trial design
Design model
Parallel
Treatments tested in this trial
CommCare with Mobile Clinical Decision Support (CDS) Application
Other interventionFor those assigned to the CHW arm, management will be assisted by CDS from the CommCare application.
Remote Supervision by Physicians
Other interventionteleconsultation with a supervising physician
CommCare Application without CDS
Other interventionThe 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.
Treatment groups
460 Participants
are divided into 2 treatment groupsGroup A: Community Health Worker CareExperimental treatment 2 interventions
Group B: Physician CareActive comparator 1 intervention
Trial outcomes
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)Other outcomes
1
Participant retention at 6 and 12 months
Time frame
6 months, 12 months2
Proportion of possible study visits completed at 6 and 12 months
Time frame
6 months, 12 months3
Mean duration of study visits
Time frame
up to 24 months4
Mean duration of physician review and care coordination time per patient encounter
Time frame
up to 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Wisconsin, Madison
Lead sponsor
Fogarty International Center of the National Institute of Health
Collaborator
Source ClinicalTrials.gov