Arterial HypertensionPreDynamiquesNCT03963934
Feasibility of a Program on a Nurse-led Telephone 6-month-follow-up for Uncontrolled Hypertensive Women
A study of Arterial Hypertension and Medication Nonadherence, run by Mme Edith DAUCHY at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years, women only
- Conditions the study is for
- Arterial Hypertension, Medication Nonadherence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 31 Oct 2020to 28 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
CHRU Nancy / Centre Investigation Clinique Plurithématique
Vandœuvre-lès-Nancy, Meurthe et Moselle, 5450
About this study
Official title: Feasibility of a Program on a Nurse-led Telephone 6-month-follow-up for Uncontrolled Hypertensive Women: a Patient-tailored Intervention
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.
Read the detailed description
The program includes 2 themes:
- "Realizing my blood pressure self-measurement" according to the recommendations
- "Optimizing my compliance": understand the antihypertensive treatment, identify the brakes and the levers when taking medication, organize the treatment taking
Visits :
- Inclusion visit :
- Collection of consent by the nurse
- Verification of inclusion and non-inclusion criteria : measurement of compliance with a scale for each antihypertensive treatment and BP measurement
- Data collection and goal setting
- Urine collection for dosing anti-hypertension drugs
- Delivery of the schedule of telephone visits that were determined with the patient
- Implementation of personalized support with the following steps :
- Data collection : evaluate knowledge and its potential as a patient, identify his needs
- Determination of objectives : define the objectives of the program in each theme with the patient according to the collection of data Implementation of personalized support
- 7 telephone interviews of 20 to 30 minutes use of specific teaching tools and materials by thematic assessment of achievements, validation of objectives Evaluation of the accompaniment:
- assessment at the final visit
- Final visit at 6-month : Same as the inclusion visit with assessment of the support and questionnaire to assess the patient satisfaction level.
- Conditions
- Arterial Hypertension, Medication Nonadherence
- Being tested
- Program on a nurse-led telephone 6-month-follow-up for uncontrolled hypertensive women: a patient-tailored intervention
- Keywords
- Nurse-led management, Home blood pressure, Nurse-led telephone follow-up
- Medical subject headings
- Hypertension, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Program on a nurse-led telephone 6-month-follow-up for uncontrolled hypertensive women: a patient-tailored interventionOther
Implementation of personalized support: The accompaniment includes 7 telephone interviews for 6 months (understanding the antihypertensive treatment, identifying the brakes and the levers when taking medication, organizing the treatment taking, making the home blood pressure)
| Study group | Role | What they receive |
|---|---|---|
| Women with uncontrolled hypertension | Experimental | Women with uncontrolled hypertension and unsatisfactory medication adherence Receives: Other: Program on a nurse-led telephone 6-month-follow-up for uncontrolled hypertensive women: a patient-tailored intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of women who completed all telephone follow-ups and came to the final visit at 6 months.
The goal of recruitment in 6 months will be 20 women and the goal of the program finalization will be of at least 80% of patients (16 patients).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start31 Oct 2020
- Primary completion28 Apr 2022
- Study completion28 Apr 2022
Why it stopped: 100% screen failure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, monocentric, open, pilot study
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mme Edith DAUCHY
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mme Edith DAUCHY, Central Hospital, Nancy, France
- Investigators
- Edith DAUCHY, RN, Principal investigator, CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03963934
- Sponsor's protocol ID
- 2019-A01921-56
- Acronym
- PreDynamiques
- Status last verified
- Jun 2026
- First submitted
- 23 May 2019
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Program on a Nurse-led Telephone 6-month-follow-up for Uncontrolled Hypertensive Women: a Patient-tailored Intervention
- ClinicalTrials.gov ID
- NCT03963934
- Acronym / sponsor ID
- PreDynamiques / 2019-A01921-56
- Conditions
- Arterial Hypertension, Medication Nonadherence
- Keywords
- Nurse-led management, Home blood pressure, Nurse-led telephone follow-up
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 100% screen failure
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Mme Edith DAUCHYUniversity, hospital or other
- Study start
- 31 Oct 2020 (actual)
- Primary completion
- 28 Apr 2022 (actual)
- Study completion
- 28 Apr 2022 (actual)
- First posted
- 28 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The program includes 2 themes:
- "Realizing my blood pressure self-measurement" according to the recommendations
- "Optimizing my compliance": understand the antihypertensive treatment, identify the brakes and the levers when taking medication, organize the treatment taking
Visits :
- Inclusion visit :
- Collection of consent by the nurse
- Verification of inclusion and non-inclusion criteria : measurement of compliance with a scale for each antihypertensive treatment and BP measurement
- Data collection and goal setting
- Urine collection for dosing anti-hypertension drugs
- Delivery of the schedule of telephone visits that were determined with the patient
- Implementation of personalized support with the following steps :
- Data collection : evaluate knowledge and its potential as a patient, identify his needs
- Determination of objectives : define the objectives of the program in each theme with the patient according to the collection of data Implementation of personalized support
- 7 telephone interviews of 20 to 30 minutes use of specific teaching tools and materials by thematic assessment of achievements, validation of objectives Evaluation of the accompaniment:
- assessment at the final visit
- Final visit at 6-month : Same as the inclusion visit with assessment of the support and questionnaire to assess the patient satisfaction level.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, monocentric, open, pilot study
| Arm | Type | Receives |
|---|---|---|
| Women with uncontrolled hypertension | Experimental | Other: Program on a nurse-led telephone 6-month-follow-up for uncontrolled hypertensive women: a patient-tailored interventionWomen with uncontrolled hypertension and unsatisfactory medication adherence |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Program on a nurse-led telephone 6-month-follow-up for uncontrolled hypertensive women: a patient-tailored interventionImplementation of personalized support: The accompaniment includes 7 telephone interviews for 6 months (understanding the antihypertensive treatment, identifying the brakes and the levers when taking medication, organizing the treatment taking, making the home blood pressure) | Other | Women with uncontrolled hypertension |
Primary outcome
Proportion of women who completed all telephone follow-ups and came to the final visit at 6 months.
Time frame: 6 months
The goal of recruitment in 6 months will be 20 women and the goal of the program finalization will be of at least 80% of patients (16 patients).
Results and safety
The study was stopped early (reason given: 100% screen failure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edith DAUCHY, RN principal investigator
CHRU Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Arterial Hypertension and Medication Nonadherence, run by Mme Edith DAUCHY at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 100% screen failure). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of women who completed all telephone follow-ups and came to the final visit at 6 months. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.