Technology-enabled Management Versus Usual Care for Blood Pressure

Study Overview
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Brief Summary
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Two arm parallel randomized clinical trial

Detailed Description
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Patients will be randomized 1:1 to receive mobile technology intervention versus usual care. Half of patients from a clinician team will receive the intervention and half will receive usual care. We aim to recruit at least 200 patients, 100 in each arm.

Official Title
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A Two-arm Parallel Randomized Clinical Trial of Implementation of Technology-enabled Management Versus Usual Care for Blood Pressure

Conditions
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Hypertension

Intervention / Treatment
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* Other: Digital Hypertension Management System
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 30-90 yrs. Smartphone ownership Office SBP: ≥ 140 mm Hg ≤ 2 current anti-HTN meds Able to add or dose-increase at least 2 of the following classes of medications: ACE-I/ARB, diuretic, calcium channel blocker, beta-blocker, mineralocorticoid receptor antagonists (i.e., at least 2 classes are available for addition or dose- increases after excluding intolerant medications and medications currently at maximum dose) English or Spanish-speakers Exclusion Criteria: Heart failure with reduced ejection fraction (EF < 40%) ESRD (GFR <15) Renal replacement therapy Pregnant Myocardial infarction or stroke within preceding 6 months Hospitalization for hypertensive emergency or malignant hypertension within preceding 6 months Prior solid organ transplantation At the clinical discretion of the investigators Enrolled in another clinical study

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized open label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile Health Technology<br> | Other: Digital Hypertension Management System<br>* Mobile health technology using physician- directed, semi-automated management of hypertension<br>|
| Active Comparator: Usual Care<br> | Other: Usual Care<br>* The participants will receive usual care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Defined Daily Dose (DDD) | Change in defined daily dose (DDD) | Visit 1 (Baseline), Visit-3 (6 Month follow up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic Blood Pressure (SBP) | Change in home SBP | Visit-1 (Baseline), Visit-3 (6 Month follow up) | 
| Diastolic blood pressure (DBP) | Change in home diastolic blood pressure (DBP) | Visit-1 (Baseline), Visit-3 (6 Month follow up) | 
| Antihypertensive Drugs | Change in number of antihypertensive drugs | Visit-1 (Baseline), Visit-3 (6 Month follow up) | 
| Systolic Blood Pressure (SBP) | Change in home SBP | Visit-1 (Baseline), Visit -2 (3 Month follow up) | 
| Physician Survey | Change in Survey score in Likert scale: Hypertension care and satisfaction | Visit 1 (Baseline), Visit-3 (6 Month follow up) | 
| Clinician inertia | Proportion of visits with blood pressure above 130/80 mm Hg where medication was not intensified | Visit 1 (Baseline), Visit-3 (6 Month follow up) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High blood pressure, Digital Health Mobile Technology, Cardiovascular risk, Clinical Research, Medications