Treatment of Hypertension: an Interventional Approach to Improve Blood Pressure Control

Study Overview
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Brief Summary
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The purpose of the study is to access the change in mean daytime systolic blood pressure in participants with essential hypertension not adequately controlled (defined as mean systolic daytime ambulatory blood pressure ≥ 135 mmHg) and randomly assigned to either an intervention group with one-time only Direct Observed Therapy (DOT) immediately followed by ABPM or a control group with standard ABPM.

Detailed Description
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More than 1 billion people world wide suffer from hypertension (HT), leaving it the world´s top rank risk factor and contributor to global disease burden. Cardiac disease, stroke, kidney disease and dementia are diseases related to HT with high economic burden on societies and each year 9.4 million people die as a direct consequence of HT. Estimated < 50 % of hypertensive patients adhere to preventive hypertensive medication after 1 year of treatment. Poor adherence to antihypertensive treatment have by many been explained partly by the silent nature of hypertension, the risk of side effects from antihypertensive medication, treatment expenditures and the patient health perspectives. In a randomized controlled trial design we plan to enrol 20 subjects, the limited number explained by the study being part of the initial planning of a larger scale trial organized by the research group, to invistigate the change in ambulatory bloodpressure with or with out Direct Observed Theraphy prior to meassurement, as a one-time-only medication adherence check.

Official Title
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Treatment of Hypertension: an Interventional Approach to Improve Blood Pressure Control

Conditions
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Hypertension

Intervention / Treatment
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* Other: Direct Observed Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years and above Residing in Oslo/Akershus Ambulatory Systolic Daytime Blood Pressure ≥ 135 mmHg ≥ 2 antihypertensive medications Be able to read and write Norwegian Exclusion Criteria: Critical illness, ongoing treatment Known atrial fibrillation Known heart valve stenosis Myocardial infarction, angina pectoris or stroke the past 6 months Known severe renal impairment (eGFR < 30 ml/min/1.73 m2) History of DOT prior to ABPM Participation in other interventional study

Ages Eligible for Study
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Minimum Age: 18 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Direct Observed Therapy<br>Direct Observed Therapy immediately followed by mounting of ambulatory blood pressure device and measurement of ambulatory blood pressure according to ESH 2013 guidelines. | Other: Direct Observed Therapy<br>* Patients allocated to the intervention group take their medication (from original blister packaged) in front of the invistigator who observe the patient swallowing the medication. To secure the principals of Direct Observed Therapy, the patient do not leave the clinic for two hours.<br>* Other names: DOT;|
| No Intervention: Control<br>Standard care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 24-hour ambulatory mean systolic daytime blood pressure |  | Measurement at follow-up visit 3 weeks ± 7 days relative to baseline. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean office systolic blood pressure |  | Measurement at follow-up visit 3 weeks ± 7 days relative to baseline. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Adherence, Direct Observed Therapy (DOT), RCT