Telemonitoring of Hypertensive Patients (LAPTOHP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01743170|
Recruitment Status : Not yet recruiting
First Posted : December 6, 2012
Last Update Posted : July 19, 2017
The proportion of hypertensive patients achieving adequate blood pressure control meeting guideline targets remains low. Of hypertensive patients, only 50% are on antihypertensive medications. Of those on blood pressure lowering drugs, only 50% have their blood pressure controlled.
The objectives of this study are:
- To test the feasibility of telemonitoring of blood pressure in Flemish general practices.
- To investigate in a randomized fashion whether telemonitoring enabled self-measurement of blood pressure leads to faster blood pressure control than self-measurement without the telemonitoring information.
- The secondary endpoints include various blood pressure indexes, adverse effects, a simple assessment of quality of life, adherence, a log of technical problems, and cost effectiveness (EQ-5D-5L).
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Other: Telemonitoring of self-measured blood pressure||Not Applicable|
Hypertension affects an estimated 20% to 30% of the world's adult population. Despite the availability of numerous safe and effective pharmacologic therapies, including single-pill combinations of 2-3 drugs, the percentage of patients achieving adequate blood pressure control meeting guideline targets remains low. The rule of halves still applies. Of hypertensive patients, only 50% are on antihypertensive medications. Of those on blood pressure lowering drugs, only 50% have their blood pressure controlled. Achieving target blood pressure levels in the treatment of hypertension requires that patients take their medications not only properly (adherence), but also continue to do so throughout long-term treatment (persistence). Poor medication-taking behavior is a major problem among patients with hypertension, and is one of the main causes of failure to achieve blood pressure control. Self-measurement of blood pressure at home improves adherence to treatment and the control of blood pressure. One might even hypothesize that telemonitoring of blood pressure, which allows instantaneous feedback between doctor and patient might even be more effective than usual self-measurement in improving adherence and reaching treatment tools.
Previous studies demonstrated the feasibility of telemonitoring of blood pressure. However, several issues remain unaddressed.
- Feasibility of telemonitoring within the Belgian context has never been tested. No attempt has ever been made in Belgium to assess adherence to antihypertensive drugs in primary care.
- Telemonitoring of blood pressure will never make it to the routine clinical practice unless it can be proven that application of the technique results in faster and better blood pressure control compared with usual care including self-measurement of blood pressure at home.
- Secondary endpoints must also include adverse events, a simple assessment of quality of life, adherence, a log of technical problems, and cost-effectiveness.
LAPTOHP is a randomized parallel-group study, which will address the feasibility and potential benefits of telemonitoring of blood pressure at home. Eligible patients will be recruited at seven general practices. LAPTOHP will include three stages
- Screening period followed by stratification and randomization: Screening involves checking inclusion and exclusion criteria, ruling out secondary hypertension remediable by specific treatment, and obtaining informed written consent as outlined in the Helsinki declaration. Eligible patients will be stratified by centre and randomized in a one-to-three proportion to control or intervention. Randomization will be implemented by sequentially numbered sealed envelopes, which contain the group assignment. These envelopes will be available at the practices, so that no contact with the Studies Coordinating Centre (SCC) will be necessary to randomize the patient.
- Randomised period: Investigators will optimize medical treatment by rotating patients through different classes of antihypertensive drugs, combining drug classes according to the current guidelines of the European Societies of Cardiology and Hypertension (ESC/ESH), while achieving the maximal tolerated dose of each drug. In the intervention group, investigators will receive a report on the telemonitoring data at weekly intervals; in the control group doctors will receive information on the self-measured blood pressure as recorded at home in the week preceding the office visit via a diary card. Doctors are free to schedule contacts with their patients and office visits at their own discretion or as indicated by the clinical context. Once blood pressure control is achieved, the blood pressure measuring devices (telemonitoring enabled or not) will be recuperated and will become available for a next patient. In the control group, patients will keep a diary card in the week preceding the office visits. In the control group, doctors will receive a full report on all telemonitoring data at the completion of randomized treatment, after patients have achieved blood pressure control.
- Late follow-up: Three months after achieving blood pressure control, all patients will be telemonitored for 1 week and complete a diary card, preceding an office visit.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Leuven Academic Programme for Telemonitoring of Hypertensive Patients|
|Estimated Study Start Date :||November 2017|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||December 2019|
No Intervention: Control group
In the control group doctors will receive information on the self-measured blood pressure as recorded at home via a diary card.
Experimental: Intervention group
In the intervention group, doctors will receive weekly reports via telemonitoring of self-measured blood pressure.
Other: Telemonitoring of self-measured blood pressure
In the intervention group, doctors receive weekly reports via telemonitoring on the self-measured blood pressure
- Time to blood pressure control [ Time Frame: During the treatment period, there will be no fixed interval between visits, so that doctors can apply their routine care scheme. Expected average of 3 months. ]Blood pressure control will be defined as a self-measured blood pressure at home below 135 mm Hg systolic and 85 mm Hg diastolic. Blood pressure control is assumed to be present if the aforementioned levels are attained during the week preceding the last office visit of the randomized treatment visit.
- Proportion of patients reaching blood pressure control on self-measurement at home and office measurement. [ Time Frame: During treatment period. No fixed time interval between visits. Expected average of 3 months. ]Blood pressure control on office measurement is a seated blood pressure below 140 mm Hg systolic and 90 mm Hg.
- The proportion of patients reaching and maintaining blood pressure control on self-measurement and office measurement at the late follow-up visit. [ Time Frame: Three months after achieving blood pressure control ]
- The intensity of medical treatment. [ Time Frame: During treatment period, up to 3 months. ]
- Adverse events [ Time Frame: During treatment period, up to 3 months. ]Adverse events will be recorded by a self-administered questionnaire (as in previous studies conducted in general practice in Belgium).
- Assessment of drug adherence. [ Time Frame: During treatment period, up to 3 months. ]The Morisky questionnaire will be used to assess drug adherence.
- Assessment of quality of life [ Time Frame: During treatment period, up to 3 months. ]The EQ-D5 questionnaire will be used for the assessment of quality of life.
- Analysis of cost-effectiveness [ Time Frame: After completion of the study (expected average is 3 months). ]The cost-effectiveness analysis will be conducted from the perspective of the Belgian health care system, including both the direct and indirect costs of the intervention. The costs will be balanced against the use of medical resources, including visits, medications, and use of medical resources.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01743170
|Contact: Jan A Staessen, MD, PhDfirstname.lastname@example.org|
|Center C2||Not yet recruiting|
|Boutersem, Belgium, BE-3370|
|Contact: Hugo Begine, MD +32-16734729 email@example.com|
|Principal Investigator: Hugo Begine, MD|
|Center C3||Not yet recruiting|
|Grimde, Belgium, BE-3300|
|Contact: Johan Wuyts, MD +32-16-821414 firstname.lastname@example.org|
|Principal Investigator: Johan Wuyts, MD|
|Center C4||Not yet recruiting|
|Leuven, Belgium, BE-3000|
|Contact: Lieve Nagels, MD +32-16-233620 email@example.com|
|Principal Investigator: Lieve Nagels, MD|
|Center C6||Not yet recruiting|
|Leuven, Belgium, BE-3000|
|Contact: Wouter Van Mechelen, MD +32-16-325454 firstname.lastname@example.org|
|Contact: Dominique Dewilde, MD +32-16-404522 email@example.com|
|Principal Investigator: Wouter Van Mechelen, MD|
|Sub-Investigator: Dominique Dewilde, MD|
|Center C7||Not yet recruiting|
|Leuven, Belgium, BE-3000|
|Contact: Myriam Bogaerts, MD +32-16-816361 firstname.lastname@example.org|
|Contact: Paul De Cort, MD +32-16-816361 email@example.com|
|Principal Investigator: Paul De Cort, MD, PhD|
|Sub-Investigator: Myriam Bogaerts, MD|
|Sub-Investigator: Eric Tousset, MD|
|Center C5||Not yet recruiting|
|Tienen, Belgium, BE-3300|
|Contact: Jeroen Vandenbrandt, MD +32-16-811206 firstname.lastname@example.org|
|Contact: Michel Reniers, MD +32-16-811206|
|Principal Investigator: Jeroen Vandenbrandt, MD|
|Sub-Investigator: Michel Reniers, MD|
|Center C1||Not yet recruiting|
|Wilsele, Belgium, BE-3012|
|Contact: Geert Pint, MD +32-16-201440 email@example.com|
|Contact: Lies Grypdonck, MD +32-16-201440 firstname.lastname@example.org|
|Principal Investigator: Geert Pint, MD|
|Sub-Investigator: Lies Grypdonck, MD|
|Principal Investigator:||Jan A Staessen, MD, PhD||University of Leuven|