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

University of Oslo (UIO)

Status: Completed

Conditions: Hypertension

Treatments: Other: Direct Observed Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02362893

2015/159

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

Direct Observed Therapy

Experimental group

Description:

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

Treatment:

Other: Direct Observed Therapy

Control

No Intervention group

Description:

Standard care