|- candidate number||3544|
|- NTR Number||NTR1363|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||30-jun-2008|
|- Secondary IDs||NHS2005B101 Dutch Heart Foundation|
|- Public Title||Electronic monitoring of the use of antihypertensive drugs in patients with "drug resistant" hypertension|
|- Scientific Title||Electronic monitoring of the use of antihypertensive drugs in patients with "drug resistant" hypertension|
|- ACRONYM||MANGO study|
|- hypothesis||Only 30% of patients, who are treated with antihypertensive drugs, reach target blood pressure levels. Noncompliance is considered to be an important cause of this lack of response to medication. In usual care, patients who do not respond to their medication often get prescriptions for other drugs or higher doses without considering whether they are compliant or not. This may result in unnecessary medication switches and dose escalations, but also to unnecessary diagnostic work-up, including costly and invasive diagnostic tests.
The hypothesis is that electronic monitoring of compliance is an effective and easy-to-use tool to improve clinically unrecognised non-compliance and thereby clinical outcome in an early phase.
|- Healt Condition(s) or Problem(s) studied||Hypertension, Drugs, Blood pressure, Compliance, Treatment resistance, Micro-Electronic Medication Event Monitoring System (MEMS)|
|- Inclusion criteria||- Eligible are patients who have drug-resistent hypertension and have no renal artery stenosis (must have been excluded by conventional renal angiography or CT angiography or MR angiography). |
Drug resistant hypertension is defined as having mean blood pressure >130/80 mm Hg according to 24-hour ambulatory blood pressure measurements (ABPM) despite the use of three or more drugs.
|- Exclusion criteria||- Patient that do not meet the inclusion criteria|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jul-2006|
|- planned closingdate||1-jul-2010|
|- Target number of participants||150|
|- Interventions||MEMS monitors are caps of pill boxes which record time and date of every opening of the pill box. Assuming that every opening is a single dose intake, a dosing history of a patient can be recorded during the monitoring period and feedback of these data to the patients is feasible. |
The electronic monitors record date and time of every opening of the pillboxes.
During follow-up visits, a research nurse will download the compliance data, discuss printed output with the patients, and if necessary will advice patients how to improve compliance by tailoring their medication use to daily schedules.
- The primary objective is to evaluate whether electronic monitoring of compliance can be used as a tool to improve compliance and thereby blood pressure control in that part of patients who do not respond to antihypertensive treatment due to clinically unrecognised compliance.
1) To what extent does electronic monitoring of compliance with antihypertensive drugs (plus feedback on compliance) in patients with "drug-resistant" hypertension lead to normalisation of blood pressure when compared with usual care?
2) Can a favourable effect on blood pressure be sustained for at least six months?
3) Can a favourable effect on blood pressure be sustained after stopping electronic monitoring?
- Secondary objectives are to evaluate whether a favourable effect
a) can be sustained for at least six months and
b) can be sustained after stopping of electronic monitoring.
|- Primary outcome||The primary outcome measure will be the proportion of patients who reach the target levels at 6 months after inclusion (question 1 and 2) and at one year after inclusion (question 3). |
|- Secondary outcome||Secondary outcome measures are: |
- The proportion of patients with substantial decrease in blood pressure (SBP > 10 mm Hg and/or DBP > 5 mm Hg)
- The compliance rate defined as percentage of days with correct number of dosing and prescribed number and doses of antihypertensive drugs.
|- Timepoints||Follow-up. The duration of follow-up will be one year in all patients. Follow-up visits will be planned every two months after inclusion. During these visits, office blood pressure will be measured and the treating physician will decide whether or not changes in antihypertensive medication are indicated. |
In the intervention group, a research nurse will be responsible for feedback of compliance data and advice to patients.
In both groups, 24-hour ambulatory blood pressure measurements (ABPM) will be performed at baseline and at the end of follow-up.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||dr. A.A. Kroon|
|- CONTACT for SCIENTIFIC QUERIES||dr. A.A. Kroon|
|- Sponsor/Initiator ||University Hospital Maastricht (AZM), Department of Internal Medicine|
(Source(s) of Monetary or Material Support)
|Dutch Heart Foundation (Nederlandse Hartstichting)|
|- Brief summary||The proposed study evaluates the effectiveness of a tool for minimising patient noncompliance with prescribed antihypertensive drugs and improving blood pressure control in these patients. |
Early diagnosis and management of poor compliance enables distinction between non-compliers and pharmacological non-responders, and thereby facilitates rational decision making as to whether or not there is an indication for medication switches or dose increases
Background: Poor compliance is assumed to occur in 50% of patients with hypertension. There is a need for easy-to-use interventions that may improve compliance with prescribed antihypertensive medication and thereby clinical outcome (blood pressure).
Study objectives: The primary objective is to evaluate whether electronic monitoring of compliance can be used as a tool to improve compliance and thereby blood pressure control in that part of patients who do not respond to antihypertensive treatment due to clinically unrecognised compliance.
Secondary objectives are to evaluate whether a favourable effect a) can be sustained for at least six months and b) can be sustained after stopping of electronic monitoring.
Design: A randomised controlled trial comparing the effectiveness of electronic monitoring with usual care. In patients randomly assigned to the intervention group (n=120), each prescribed antihypertensive drug will be supplied in electronically monitored drug packages (MEMSŪ monitors, Aardex, Switzerland) during 6 months. Patients in the control group will receive usual care (without electronic monitoring) (n=30). Within the intervention group, a second randomisation will take place at the end of the 6-month monitoring period: half of the patients will continue to use electronic monitors for another 6 months and the other half of patients will stop using electronic monitors.
Expected results: It is expected that electronic monitoring results in better blood pressure control in patients with clinically unrecognised compliance problems and reduces the need for more drugs and higher doses in these patients.
|- Main changes (audit trail)|
|- RECORD||30-jun-2008 - 25-jul-2008|