Health Services Administration, Hypertension, Telemedicine
Conditions
Keywords
Telecommunication, Telecare, Teleconsult, Telemanagement, Telemonitoring
Brief summary
Rater blinded, multi-center, prospective, randomized controlled study comparing mean 24 hour systolic blood pressure of eligible hypertensive patients in the TELEMONITORIN group versus the USUAL CARE group, at 6 months after inclusion.
Interventions
PROCEDURETelemonitoring
* A weekly telephone call by the CRA for the collection of home blood pressure measurements (which the patient measures twice a day everyday), for therapeutic education, and for treatment compliance assessment. * A monthly call by the attending physician for treatment titration and side effects check.
PROCEDUREUsual Care without Telemonitoring
* Attending the follow up visits after inclusion at Day 90 (D-90) & Day 180 (D-180) for face to face consultation with the attending physician. * Usual care without any phone calls for therapeutic education, treatment compliance assessment, treatment titration or side effects check.
Sponsors
Les Laboratoires des Médicaments Stériles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Intervention model description
The interventional group (Telemonitoring) in addition to the usual care group (conventional) will benefit from: * a weekly telephone call for collection of home Blood Pressure measurements , therapeutic education & treatment compliance check * a monthly call for treatment titration and side effects check
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Included are patients with: * age ≥ 35 years old * newly diagnosed hypertention * uncontrolled hypertention
Exclusion criteria
Excluded are patients with: * orthostatic hypotension * chronic renal failure (serum creatinine \> 200 micromol / L) * acute coronary syndrome * coronary revascularization or stroke within the past 3 months * known secondary causes of hypertension * pregnancy * New York Heart Association Class III or IV heart failure or left ventricular ejection fraction \< 30% * dementia or another cause that prevents the application of remote monitoring
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean of 24h systolic blood pressure (SBP) | 0 - 180 days | The change from baseline of mean 24-hour systolic blood pressure (SBP) at 6 months of follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean of 24h diastolic blood pressure (DBP) | 0-180 days | The change from baseline of mean 24 hour diastolic blood pressure (DBP) at 6 months of follow-up |
| percentage of blood pressure load | 0-180 days | The change of blood pressure load's percentages between baseline and 6 months of follow-up |
| percentage of Dipping | 0-180 days | The change of dipping percentages between baseline and 6 months of follow-up |
| Mean of the Short Form survey (SF-12) scores | 0-180 days | The change in the mean of SF-12 scores between baseline and 6 months of follow-up |
| frequency of cardiovascular complications | 180 days | Clinical outcomes including hospitalization rate, emergency room admissions related to high blood pressure, adverse effects, or other reasons |
Countries
Tunisia
Contacts
Primary ContactSemir NOUIRA, Prof
Backup ContactSonia BEN HAFAIEDH, MD
Outcome results
None listed