Telemonitoring of Hypertensive Patients — LAPTOHP  

Hypertension Clinical Trial

Official title: Leuven Academic Programme for Telemonitoring of Hypertensive Patients

Status Suspended

Clinical Trial Summary

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:

1. To test the feasibility of telemonitoring of blood pressure in Flemish general practices.

2. 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.

3. 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).

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Hypertension

• NCT number: NCT01743170
• Study type: Interventional
• Source: KU Leuven
• Status: Suspended
• Phase: N/A
• Start date: June 1, 2020
• Completion date: December 31, 2022