Treatment of Hypertension: an Interventional Approach to Improve Blood Pressure Control (DRIVE)
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|ClinicalTrials.gov Identifier: NCT02362893|
Recruitment Status : Recruiting
First Posted : February 13, 2015
Last Update Posted : April 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Other: Direct Observed Therapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Hypertension: an Interventional Approach to Improve Blood Pressure Control|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: 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.
Other: 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.
Other Name: DOT
No Intervention: Control
- Change in 24-hour ambulatory mean systolic daytime blood pressure [ Time Frame: Measurement at follow-up visit 3 weeks ± 7 days relative to baseline. ]
- Change in mean office systolic blood pressure [ Time Frame: Measurement at follow-up visit 3 weeks ± 7 days relative to baseline. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02362893
|Contact: Aud Høieggen, MD PhDfirstname.lastname@example.org|
|Contact: Ulla P Hjørnholm, Bacheloremail@example.com|
|Oslo University Hospital||Recruiting|
|Oslo, Norway, 0407|
|Contact: Aud Hoieggen, MD PhD firstname.lastname@example.org|
|Contact: Ulla P. Hjoernholm email@example.com|
|Principal Investigator:||Aud Høieggen, MD PhD||Oslo University Hospital|