Telemonitoring of Hypertensive Patients

NCT01743170 | Suspended

• 1 other identifier: LAPTOHP
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 7

Brief 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. 1.To test the feasibility of telemonitoring of blood pressure in Flemish general practices.
2. 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. 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).

Conditions

Hypertension

Keywords

Blood pressure control; Hypertension; Office blood pressure; Self-measured blood pressure; Telemonitoring

Outcome Measures

Primary Outcomes (1)

• Time to blood pressure control

  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.

  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.

Secondary Outcomes (7)

• Proportion of patients reaching blood pressure control on self-measurement at home and office measurement.

  During treatment period. No fixed time interval between visits. Expected average of 3 months.

• The proportion of patients reaching and maintaining blood pressure control on self-measurement and office measurement at the late follow-up visit.

  Three months after achieving blood pressure control

• The intensity of medical treatment.

  During treatment period, up to 3 months.

• Adverse events

  During treatment period, up to 3 months.

• Assessment of drug adherence.

  During treatment period, up to 3 months.

Study Arms (2)

Control group

NO INTERVENTION

In the control group doctors will receive information on the self-measured blood pressure as recorded at home via a diary card.

Intervention group

EXPERIMENTAL

In the intervention group, doctors will receive weekly reports via telemonitoring of self-measured blood pressure.

Other: Telemonitoring of self-measured blood pressure

Interventions

Telemonitoring of self-measured blood pressure OTHER

In the intervention group, doctors receive weekly reports via telemonitoring on the self-measured blood pressure

Intervention group

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women and men are eligible. Women of reproductive age should apply effective contraception.
• Age ranges from 20 years (inclusive) to less than 80 years.
• Patients should have hypertension, which is uncontrolled on medical treatment.
• At the screening visit, patients should either be untreated for at least 4 weeks or taking a stable drug regimen for at least 4 weeks.
• Medical treatment can consist of all major drug classes. This includes diuretics, β-blockers, α-blockers, calcium-channel blockers (CCBs), inhibitors of the rennin system (angiotensin-converting enzyme inhibitors (ACEIs), angiotensin II type-1 receptor blockers (ARBs), the direct renin inhibitor aliskiren, aldosterone receptor antagonists (ARAs) centrally acting antihypertensive drugs and vasodilators (hydralazine). In line with current recommendations and recent studies, unless contra-indicated or not tolerated, aldosterone antagonists, such as spironolactone 25 to 50 mg per day should have been attempted for at least 4 weeks to improve blood pressure control in treatment-resistant patients.
• The patients should be intellectually and emotionally capable of measuring their blood pressure at home and accept to keep a diary (control group) or to have a report sent to their doctor (intervention group).
• Patient should provide written informed consent.

You may not qualify if:

• The clinical context is suboptimal for telemonitoring of blood pressure:
• Myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months of the screening period.
• Type-1 diabetes mellitus requiring multiple adjustments of treatment to maintain control or diabetes mellitus with recent hyperglycemic or hypoglycemic coma.
• Renal dysfunction defined as an estimated glomerular filtration rate (eGFR) of less than 30 mL/min/1.73m², using the Modification of Diet in Renal Disease (MDRD) formula.
• Secondary hypertension, in which treatment options other than antihypertensive drug treatment are indicated.
• Sleep apnea syndrome that qualifies for treatment with continuous positive airway pressure (CPAP).
• Atrial fibrillation or arrhythmia making oscillometric blood pressure measurement unreliable.
• The patient is on a waiting list for elective surgery or a cardiovascular intervention.
• Patients with alcohol or substance abuse or psychiatric illnesses.
• The patients should not have any serious medical condition, which in the opinion of the investigator, may adversely interfere with self-measurement of blood pressure at home.
• Patients should not participate in any other trial of an investigational drug or device.

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (7)

Center C2

Boutersem, BE-3370, Belgium

Location

Center C3

Grimde, BE-3300, Belgium

Location

Center C4

Leuven, BE-3000, Belgium

Location

Center C6

Leuven, BE-3000, Belgium

Location

Center C7

Leuven, BE-3000, Belgium

Location

Center C5

Tienen, BE-3300, Belgium

Location

Center C1

Wilsele, BE-3012, Belgium

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jan A Staessen, MD, PhD

  University of Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: December 3, 2012
• First Posted: December 6, 2012
• Study Start: June 1, 2020
• Primary Completion: July 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 3, 2020

Record last verified: 2020-03

Locations

BE (7)