UnknownNot Applicable

Impact of an IT-Based and Healthcare Professional Support Program on Patients With High Blood Pressure

Canada223 participantsStarted 2004-05

Plain-language summary

The study is a randomised controlled trial to evaluate the impact of a program using information technology (IT) and healthcare professional support in patients with high blood pressure (BP) compared to usual care. The program helps patients monitor their own BP and medication and keeps nurses,physicians and pharmacists informed while respecting patient confidentiality. The IT system links directly with the patient's pharmacy data. Using pharmacy data and responses to questions on compliance and BP control, the IT system provides appropriate counselling, telephone reminders, generates prescription refill and renewal reminder calls and monitors BP. The system reports compliance and self recorded BP measurements to healthcare providers and also links with a nurse. This is so that the nurse, the patient's doctor and pharmacist can help answer questions about medication and controlling high blood pressure. A total of 500 patients in Laval, Quebec will participate in the study. Half of the patients will have the program plus usual care and the other have usual care only. We hypothesize that the program will improve BP control by helping patients take their medication properly and by helping doctors ensure that the best strength and kinds of medication are used to control high blood pressure. We believe the program will achieve this by helping to improve communication between patients and healthcare providers, without adversely impacting quality of life. Additional sub-studies will determine if the program is cost effective and can be applied in real practice and if the program helps patients, doctors, pharmacists and nurses communicate better.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female with untreated or suboptimally controlled hypertension * Age equal to or greater than 18 years * Ambulatory outpatients currently being treated in primary care setting * Capable of giving informed consent * Able to communicate in and read either French or English * Purchase their medication at a pharmacy participating in the program * Agree to stay with one pharmacy for the duration of the study * Able to have a 24 hour ABPM recording within 7 days of screening * Written informed consent obtained Exclusion Criteria: * Unlikely to complete study due to life-threatening disease or condition * Having chronic atrial fibrillation * Unable to use an ordinary telephone * Pregnant at the initial visit * Participating in another clinical trial concomitantly * Participated in an antihypertensive clinical trial within the past 2 months * Living with another subject that is currently participating in the study * Delaying pharmacotherapy for baseline ABPM could put the subject at risk.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in the mean 24-hour systolic and diastolic BP using ABPM

Timeframe: 12 months

Trial details

NCT IDNCT00374829

SponsorUniversité de Montréal

Sponsor typeOTHER

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Hypertension trials