Community Health Worker-led Hypertension Management

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06444308
• Other study ID #: 2024-0566
• Secondary ID: A532050Protocol
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2024
• Est. completion date: August 2026

Study information

• Verified date: May 2024
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• CommCare with Mobile Clinical Decision Support (CDS) Application
For those assigned to the CHW arm, management will be assisted by CDS from the CommCare application.
• Remote Supervision by Physicians
teleconsultation with a supervising physician
• CommCare Application without CDS
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Fogarty International Center of the National Institute of Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Participant retention at 6 and 12 months		6 months, 12 months
Other	Proportion of possible study visits completed at 6 and 12 months		6 months, 12 months
Other	Mean duration of study visits		up to 24 months
Other	Mean duration of physician review and care coordination time per patient encounter		up to 24 months
Other	Comparison of antihypertensive medications prescribed and dosages		up to 24 months
Other	Proportion of patients with an indication taking aspirin		up to 24 months
Other	Proportion of patients taking two or more antihypertensives		up to 24 months
Other	Estimated cost of care		up to 24 months
Primary	Change in Systolic Blood Pressure (SBP)		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	Proportion of Participants with SBP less than 140mmHg		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	Proportion of Participants with SBP less than their personalized goal		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	Change in Diastolic Blood Pressure (DBP)		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	Change in Hemoglobin A1c (HbA1c)		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	Change in Weight		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	Change in Total Cholesterol		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	Change in LDL Cholesterol		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	Change in HDL Cholesterol		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	Change in Triglycerides		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	Change in Creatinine		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	Change in Estimated Glomerular Filtration Rate (eGFR)		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	Change in 10 year CVD risk (per WHO risk prediction charts)		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	Change in Hypertension Self-Care Activity Level Effects (H-SCALE): Medication Adherence Subscale Score	The H-SCALE: Medication Adherence subscale is scored from 0-21 where higher scores indicate a more positive attitude toward adherence.	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	Change in H-SCALE: Weight Management Score	The H-SCALE: Weight Management subscale is scored from 9-45 where higher scores indicate a more positive attitude toward weight management.	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	Change in H-SCALE: Physical Exercise Score	The H-SCALE: Physical Exercise subscale is scored from 0-14 where higher scores indicate a more positive behavior toward physical exercise.	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	Change in H-SCALE: Smoking Exposure Score	The H-SCALE: Smoking Exposure subscale is scored from 0-14 where a score of 0 indicates a more positive attitude toward smoking exposure.	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	Change in H-SCALE: Alcohol Intake Score	The H-SCALE: Alcohol Intake subscale contains three questions and is scored as abstainer (does not drink) or non-adherent (reported drinking alcohol).	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	Change in H-SCALE: Healthy Eating Plan Score	The H-SCALE: Healthy Eating Plan subscale is scored from 0-70 where higher scores indicate a more positive attitude toward healthy eating.	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	Change in selected items from the Patient Assessment of Chronic Illness Care (PACIC) survey	PACIC will be scored from X-XX where higher scores indicate better assessment of chronic illness care.	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	Change in global hypertension care satisfaction score	[How is this scored?]	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	Change in pill count adherence ratio (PCAR)	[How is this defined?]	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	Change in self-reported adherence	[How is this scored?]	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)