TerminatedNot Applicable

Feasibility of a Program on a Nurse-led Telephone 6-month-follow-up for Uncontrolled Hypertensive Women

Stopped: 100% screen failure

France14 participantsStarted 2020-10-31

Plain-language summary

This study evaluate the feasibility of a 6-month personalized support program for hypertensive and non-observant women, led by nurses by telephone follow-up.

Who can participate

Age range

18 Years – 79 Years

Sex

FEMALE

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: * Woman ≥ 18 to 79 years old, * Hypertensive and treated with antihypertensive drug(s) * Unsatisfactory compliance for at least one of her antihypertensive treatment with a score below 80% at the medication adherence scale * Uncontrolled Blood Pressure (BP) : systolic BP equals to or greater than140 and / or diastolic BP equals to or greater than 90 mmHg at inclusion visit * Informed consent signed * Affiliation to a French social security scheme or beneficiary of such a scheme Exclusion Criteria: * Patient with a history of cardio or cerebrovascular disease in the last 6 months (Stroke or Transient Ischemic Attack, myocardial infarction, heart failure) * Patient with kidney failure requiring dialysis * Patient with cognitive pathology: dementia, ... etc. * Patient with type I diabetes * Unreachable patient by phone or foreseeable inability or unwillingness to comply with study follow-up * Patient who does not understand and does not speak French

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

Proportion of women who completed all telephone follow-ups and came to the final visit at 6 months.

Timeframe: 6 months

Trial details

NCT IDNCT03963934

SponsorMme Edith DAUCHY

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04-28

View on ClinicalTrials.gov More Arterial Hypertension trials