CompletedNot Applicable

Study of a Comprehensive Intelligent Hypertension managEment SyStem

China1,666 participantsStarted 2023-03-16

Plain-language summary

This cluster randomized controlled trial aims to evaluate the efficacy of a comprehensive intelligent hypertension management system (CHESS) in blood pressure lowering in primary health care (PHC) settings of China.

Who can participate

Age range

35 Years – 79 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

. An electronic data collection system is routinely used at the clinic for hypertension management in PHC sites, and the distance between sites must be \>2km;
. At least one drug of each of the five classes of recommended antihypertensive medications is available at the clinic:
. Has an outpatient clinic for hypertension treatment and staff are willing to take part in the study.
. Age ≥35 years and \<80 years
. Local resident of the community/township who attends the PHC clinic for hypertension management, and will not travel for more than 3 months during the study period;
. Established diagnosis of essential hypertension, with uncontrolled BP before randomization (defined as office BP≥140/90mmHg, and 24-hour ambulatory BP≥130/80mmHg);
. Own and be able to use a smartphone daily;
. Be willing to participate in the study and sign the informed consent.

Exclusion criteria

. Physician-diagnosed or suspected secondary hypertension (e.g. hypertension caused by renal disease, renal artery stenosis, aortic stenosis, primary aldosteronism, pheochromocytoma/paraganglioma, Cushing's syndrome, thyroid dysfunction, intracranial disease, drug- induced, or rare monogenic genetic disease), or the presence of other structural heart diseases, such as aortic insufficiency, hypertrophic cardiomyopathy, or congenital heart disease;

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

Mean change in 24-hour ambulatory SBP from baseline to 12-month follow up;

Timeframe: Baseline; 12 months

Trial details

NCT IDNCT05605418

SponsorChina National Center for Cardiovascular Diseases

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2024-10-30

View on ClinicalTrials.gov More Hypertension trials