HypertensioniIPArétroNCT06227884
Impact of Advanced Practical Nursing Intervention Versus Usual Care on Hypertension Control : Retrospective Study
An observational study of Hypertension, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Hypertension is the most frequent chronic pathology in France and in the world. It is one of the main modifiable cardiovascular risk factors. In France, 50% of treated hypertensives are uncontrolled and only 30% of treated patients are fully adherent to their antihypertensive treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- APN intervention and No APN intervention
- How many people
- 483 participants
- Where
- 1 siteFrance
- Study dates
- 8 Mar 2024to 22 Apr 2024
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Adults with essential hypertension, recruited in day hospitalization unit: HDJ CITE of the Hôtel-Dieu Hospital.
Who may be able to join
- adult patient
- being diagnosed with essential hypertension,
- being followed by a MD of the structure for hypertension management,
- having received a proposition to meet an APN for hypertension management between the day hospitalization and the next MD consultation,
- having received a loaned tensiometer with instructions during the day hospitalization and explanations for HBPM protocol.
Who cannot join
- being diagnosed with secondary hypertension,
- having APN follow-up before the day hospitalization,
- being lost to follow-up in the twelve months after the MD consultation
- not having the BP measurement by OBPM for the day hospitalization (baseline) and/or the endline (endline),
- pregnancy
- under guardianship or tutorship
- State Medical Help
Trial locations and contacts
1 site in 1 country.
France1 site
Diagnosis and Therapeutic Center, Hôtel-Dieu University Hospital, Assistance Publique-Hôpitaux de Paris
Paris, Île-de-France Region, 75004
About this study
Official title: Impact of Advanced Practical Nursing Intervention Versus Usual Care on Hypertension Control : Retrospective Single-center Quasi-experimental Study
Hypertension is the most frequent chronic pathology in France and in the world. It is one of the main modifiable cardiovascular risk factors. In France, 50% of treated hypertensives are uncontrolled and only 30% of treated patients are fully adherent to their antihypertensive treatment. Poor adherence to drug treatments is considered as one of the main causes of non-control of hypertension.
Since 2018, a new profession has entered the French healthcare system: Advanced Practice Nurses (APN). They have many broad skills, at the interface of nursing and medical exercises.
Read more
The purpose of this interventional study is to assess the impact of APN on blood pressure (BP) control in the context of usual care of hypertension thanks to a better adhesion of patients and a better therapeutic alliance.
The hypothesis formulated is that an individual APN intervention, included in a usual hypertension management, improves BP control.
Read the detailed description
Hypertension is the most frequent chronic pathology in France and in the world. It is one of the main modifiable cardiovascular risk factors. In France, 50% of treated hypertensives are uncontrolled and only 30% of treated patients are fully adherent to their antihypertensive treatment. Poor adherence to drug treatments is considered as one of the main causes of non-control of hypertension.
Since 2018, a new profession has entered the French healthcare system: Advanced Practice Nurses (APN). They have many broad skills, at the interface of nursing and medical exercises.
The purpose of this interventional study is to assess the impact of APN on blood pressure (BP) control in the context of usual care of hypertension thanks to a better adhesion of patients and a better therapeutic alliance.
The hypothesis formulated is that an individual APN intervention, included in a usual hypertension management, improves BP control.
This study will be a retrospective quasi-experimental study, conducted at the Diagnosis and Therapeutic Center of the Hôtel-Dieu University Hospital, Assistance Publique - Hôpitaux de Paris, France. The timeframe of the study should is from September 2020 to July 2023.
- Conditions
- Hypertension
- Being tested
- APN intervention, No APN intervention
- Keywords
- Advanced practice nurse, Hypertension, Therapeutic adherence, Trial
- Medical subject headings
- Hypertension, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APN interventionOther
Participants with a schedule of a MD consultation (within approximately 2 to 12 months) + an APN intervention halfway between day hospitalization et MD consultation
APN intervention is divided into five main steps:
- clinical and paraclinical examinations,
- appraisal of patient's knowledge,
- health education on hypertension and treatments,
- setting a written medication plan with the patient to invest him in his management with adjusting or renewing treatments identically if necessary
- decision-making balance between the benefits and risks of non-adherence to medication. A time is scheduled at the end of the intervention to let the patient ask questions or express his difficulties if he needs to.
No APN interventionOther
Participants with a schedule of a MD consultation (within approximately 2 to 12 months)
| Study group | Role | What they receive |
|---|---|---|
| Patients with APN intervention | Participants with a schedule of a MD consultation (within approximately 2 to 12 months) + an APN intervention halfway between day hospitalization et MD consultation Receives: Other: APN intervention | |
| Patients without APN intervention | Participants with a MD consultation only, within approximately 2 to 12 months Receives: Other: No APN intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure (BP) control
Blood pressure (BP) control in MD consultation
- Rate of BP control (BP < 140/90 mmHg)
- Mean (SD) of both systolic and diastolic BP
Measured: Between 2 to 12 months
Secondary outcomes (4)
Home blood pressure monitoring (HBPM)
Performance and quality of home BP monitoring (HBPM). 3-category variable: HBPM perfectly performed, HBPM poorly performed, and HBPM not performed.
Measured: Between 2 to 12 months
Blood pressure (BP) control
Evolution of BP control between day hospitalization and MD consultation. 3-category variable: now controlled, stable, no longer controlled
Measured: Day hospitalization - Inclusion
Blood pressure (BP) control
Evolution of BP control between day hospitalization and MD consultation. 3-category variable: now controlled, stable, no longer controlled
Measured: Between 2 to 12 months
Therapeutic adjustments
Group with APN :
Therapeutic adjustments and their indication(s) by the APN. Dichotomous variables: therapeutic adjustments (yes/no) and their indication(s): inefficacy (yes/no) and intolerance (yes/no).
Measured: Between 2 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start8 Mar 2024
- Primary completion22 Apr 2024
- Study completion22 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 483 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Jacques BLACHER, MD, PhD, Study chair, Diagnosis and Therapeutic Center, Hôtel-Dieu University Hospital, Assistance Publique-Hôpitaux de Paris, Paris University, 75004 Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227884
- Sponsor's protocol ID
- APHP231667
- Acronym
- iIPArétro
- Status last verified
- Sep 2025
- First submitted
- 18 Jan 2024
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Vay-Demouy J, Lelong H, Blacher J. Advanced Practice Nurse Intervention Versus Usual Care for Hypertension Control: A Pilot Open-Label Randomized Controlled Trial. J Clin Hypertens (Greenwich). 2025 May;27(5):e70068. doi: 10.1111/jch.70068.
PubMed 40346888
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Advanced Practical Nursing Intervention Versus Usual Care on Hypertension Control : Retrospective Single-center Quasi-experimental Study
- ClinicalTrials.gov ID
- NCT06227884
- Acronym / sponsor ID
- iIPArétro / APHP231667
- Conditions
- Hypertension
- Keywords
- Advanced practice nurse, Hypertension, Therapeutic adherence, Trial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 483 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 8 Mar 2024 (actual)
- Primary completion
- 22 Apr 2024 (actual)
- Study completion
- 22 Apr 2024 (actual)
- First posted
- 29 Jan 2024 (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.
Hypertension is the most frequent chronic pathology in France and in the world. It is one of the main modifiable cardiovascular risk factors. In France, 50% of treated hypertensives are uncontrolled and only 30% of treated patients are fully adherent to their antihypertensive treatment. Poor adherence to drug treatments is considered as one of the main causes of non-control of hypertension.
Since 2018, a new profession has entered the French healthcare system: Advanced Practice Nurses (APN). They have many broad skills, at the interface of nursing and medical exercises.
The purpose of this interventional study is to assess the impact of APN on blood pressure (BP) control in the context of usual care of hypertension thanks to a better adhesion of patients and a better therapeutic alliance.
The hypothesis formulated is that an individual APN intervention, included in a usual hypertension management, improves BP control.
Detailed description
Hypertension is the most frequent chronic pathology in France and in the world. It is one of the main modifiable cardiovascular risk factors. In France, 50% of treated hypertensives are uncontrolled and only 30% of treated patients are fully adherent to their antihypertensive treatment. Poor adherence to drug treatments is considered as one of the main causes of non-control of hypertension.
Since 2018, a new profession has entered the French healthcare system: Advanced Practice Nurses (APN). They have many broad skills, at the interface of nursing and medical exercises.
The purpose of this interventional study is to assess the impact of APN on blood pressure (BP) control in the context of usual care of hypertension thanks to a better adhesion of patients and a better therapeutic alliance.
The hypothesis formulated is that an individual APN intervention, included in a usual hypertension management, improves BP control.
This study will be a retrospective quasi-experimental study, conducted at the Diagnosis and Therapeutic Center of the Hôtel-Dieu University Hospital, Assistance Publique - Hôpitaux de Paris, France. The timeframe of the study should is from September 2020 to July 2023.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with APN intervention | – | Other: APN interventionParticipants with a schedule of a MD consultation (within approximately 2 to 12 months) + an APN intervention halfway between day hospitalization et MD consultation |
| Patients without APN intervention | – | Other: No APN interventionParticipants with a MD consultation only, within approximately 2 to 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults with essential hypertension, recruited in day hospitalization unit: HDJ CITE of the Hôtel-Dieu Hospital.
Key inclusion criteria (5 listed)
- adult patient
- being diagnosed with essential hypertension,
- being followed by a MD of the structure for hypertension management,
- having received a proposition to meet an APN for hypertension management between the day hospitalization and the next MD consultation,
- having received a loaned tensiometer with instructions during the day hospitalization and explanations for HBPM protocol.
Key exclusion criteria (7 listed)
- being diagnosed with secondary hypertension,
- having APN follow-up before the day hospitalization,
- being lost to follow-up in the twelve months after the MD consultation
- not having the BP measurement by OBPM for the day hospitalization (baseline) and/or the endline (endline),
- pregnancy
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 |
|---|---|---|
| APN interventionParticipants with a schedule of a MD consultation (within approximately 2 to 12 months) + an APN intervention halfway between day hospitalization et MD consultation APN intervention is divided into five main steps: * clinical and paraclinical examinations, * appraisal of patient's knowledge, * health education on hypertension and treatments, * setting a written medication plan with the patient to invest him in his management with adjusting or renewing treatments identically if necessary * decision-making balance between the benefits and risks of non-adherence to medication. A time is scheduled at the end of the intervention to let the patient ask questions or express his difficulties if he needs to. | Other | Patients with APN intervention |
| No APN interventionParticipants with a schedule of a MD consultation (within approximately 2 to 12 months) | Other | Patients without APN intervention |
Primary outcome
Blood pressure (BP) control
Time frame: Between 2 to 12 months
Blood pressure (BP) control in MD consultation * Rate of BP control (BP < 140/90 mmHg) * Mean (SD) of both systolic and diastolic BP
4 secondary outcomes
Home blood pressure monitoring (HBPM)
Time frame: Between 2 to 12 months
Blood pressure (BP) control
Time frame: Day hospitalization - Inclusion
Blood pressure (BP) control
Time frame: Between 2 to 12 months
Therapeutic adjustments
Time frame: Between 2 to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Results publication: PubMed 40346888Vay-Demouy J, Lelong H, Blacher J. Advanced Practice Nurse Intervention Versus Usual Care for Hypertension Control: A Pilot Open-Label Randomized Controlled Trial. J Clin Hypertens (Greenwich). 2025 May;27(5):e70068. doi: 10.1111/jch.70068.
- Individual participant dataSharing planned: Undecided
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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.
Jacques BLACHER, MD, PhD study chair
Diagnosis and Therapeutic Center, Hôtel-Dieu University Hospital, Assistance Publique-Hôpitaux de Paris, Paris University, 75004 Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Assistance Publique - Hôpitaux de Paris 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 12 Sep 2025. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Blood pressure (BP) control (time frame: Between 2 to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06227884, which also lists 1 linked publication.
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 12 Sep 2025.