Hypertension
Conditions
Keywords
Hypertension, Adherence, Direct Observed Therapy (DOT), RCT
Brief summary
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
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.
Interventions
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.
Sponsors
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Change in mean office systolic blood pressure | Measurement at follow-up visit 3 weeks ± 7 days relative to baseline. |
Countries
Norway
Outcome results
None listed