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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2018-12-31

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.

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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.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Direct Observed Therapy

Direct Observed Therapy immediately followed by mounting of ambulatory blood pressure device and measurement of ambulatory blood pressure according to ESH 2013 guidelines.

Group Type EXPERIMENTAL

Direct Observed Therapy

Intervention Type OTHER

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.

Control

Standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Direct Observed Therapy

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.

Intervention Type OTHER

Other Intervention Names

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DOT

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No