HypertensioniIPANCT05917600
Impact of Advanced Practical Nursing Intervention Versus Usual Care on Hypertension Control
A study testing APN intervention in people with 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2023to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age,
- Essential Hypertension
- Hypertension management in Hôtel-Dieu Hospital
- Ability to provide a written informed consent.
Who cannot join
- Have already benefited from an APN follow-up before the day of inclusion
- Being under guardianship or curatorship
- Pregnant patient
- Beneficiary of the AME (state medical aid)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Diagnosis and Therapeutic Center, Hôtel-Dieu Hospital
Paris, IDF, 75004
Juliette VAY-DEMOUY, 0033142348551, juliette.vaydemouy@aphp.fr
About this study
Official title: Impact of Advanced Practical Nursing Intervention Versus Usual Care on Hypertension Control: Study Protocol for an Open-label Randomized Controlled Trial
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
This study will be a prospective, open-label, randomized 1-to-1 and monocentric trial, conducted at the Diagnosis and Therapeutic Center of the Hôtel-Dieu University Hospital, Assistance Publique - Hôpitaux de Paris, France.
Recruitment will be conducted during the ambulatory hospitalization. After the signature of the consent form, the randomization will be conducted during the ambulatory hospitalization. All recruited patients will be randomized.
According to the randomization, the odd-numbered participants will constitute the "usual care" group, and the even-numbered patients will constitute the "intervention" group.
The "usual care" group will keep a traditional follow-up: ambulatory hospitalization then consultation with a MD within approximately 2 to 12 months.
The "intervention" group will meet the APN between the ambulatory hospitalization and the MD consultation, within 1 to 6 months.
The participants will get their study appointment(s) (MD consultation +/- APN intervention) at the end of the ambulatory hospitalization according to their allocation.
- Conditions
- Hypertension
- Being tested
- 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
Advanced Practice Nurses (APN) intervention between the ambulatory hospitalization (AH) and the 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.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | The interventional group meets an Advanced Practice Nurses (APN) between the ambulatory hospitalization (AH) and the MD consultation Receives: Other: APN intervention |
| Control group | No intervention | The control group of patients keeps a traditional follow-up (ambulatory hospitalization (AH) then consultation with a MD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure control
Blood pressure < 140/90 mmHg
Measured: Medical consultation, from 2 months to 12 months after inclusion
Secondary outcomes (6)
Rate of patients who brought HBPM to consultation
Ability to realize a home blood pressure measurement Blood pressure control in home blood pressure measurement (HBPM)
Measured: Medical consultation, from 2 months to 12 months after inclusion
Number of measurements
Ability of HBPM Quality of the HBPM : Number of measurements carried out over 3 days (18 measurements over 3 days according to protocol) then divided into 4 categories: performance (18 measurements), average performance (17 to 15 measurements), average performance (14 to 12 measurements or less), poor performance (11 measures or less).
Measured: Medical consultation, from 2 months to 12 months after inclusion
Rate of Blood pressure control
Difference between inclusion and the Medical consultation, from 2 months to 12 months after inclusion
Measured: Medical consultation, from 2 months to 12 months after inclusion
Rate of therapeutic adjustments
Rate of therapeutic adjustments due to side effects
Measured: Medical consultation, from 2 months to 12 months after inclusion
Rate of therapeutic adjustments
Rate of therapeutic adjustments due to uncontrolled hypertension
Measured: Medical consultation, from 2 months to 12 months after inclusion
Rate of therapeutic adjustments
Rate of therapeutic adjustments : other reason
Measured: Medical consultation, from 2 months to 12 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study startJun 2023 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques BLACHER, MD, PhD, Principal investigator, Diagnosis and Therapeutic Center, Hôtel-Dieu Hospital, Assistance Publique-Hôpitaux de ParisJuliette VAY-DEMOUY, MSc, PhD, Study director, Diagnosis and Therapeutic Center, Hôtel-Dieu Hospital, Assistance Publique-Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917600
- Sponsor's protocol ID
- APHP230450
- Other IDs
- 2023-A00189-36
- Acronym
- iIPA
- Status last verified
- May 2023
- First submitted
- 14 Jun 2023
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. 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: Study Protocol for an Open-label Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05917600
- Acronym / sponsor ID
- iIPA / APHP230450
- Conditions
- Hypertension
- Keywords
- Advanced practice nurse, Hypertension, Therapeutic adherence, Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 26 Jun 2023 (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
This study will be a prospective, open-label, randomized 1-to-1 and monocentric trial, conducted at the Diagnosis and Therapeutic Center of the Hôtel-Dieu University Hospital, Assistance Publique - Hôpitaux de Paris, France.
Recruitment will be conducted during the ambulatory hospitalization. After the signature of the consent form, the randomization will be conducted during the ambulatory hospitalization. All recruited patients will be randomized.
According to the randomization, the odd-numbered participants will constitute the "usual care" group, and the even-numbered patients will constitute the "intervention" group.
The "usual care" group will keep a traditional follow-up: ambulatory hospitalization then consultation with a MD within approximately 2 to 12 months.
The "intervention" group will meet the APN between the ambulatory hospitalization and the MD consultation, within 1 to 6 months.
The participants will get their study appointment(s) (MD consultation +/- APN intervention) at the end of the ambulatory hospitalization according to their allocation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Other: APN interventionThe interventional group meets an Advanced Practice Nurses (APN) between the ambulatory hospitalization (AH) and the MD consultation |
| Control group | No intervention | –The control group of patients keeps a traditional follow-up (ambulatory hospitalization (AH) then consultation with a MD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years of age,
- Essential Hypertension
- Hypertension management in Hôtel-Dieu Hospital
- Ability to provide a written informed consent.
Key exclusion criteria (4 listed)
- Have already benefited from an APN follow-up before the day of inclusion
- Being under guardianship or curatorship
- Pregnant patient
- Beneficiary of the AME (state medical aid)
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 interventionAdvanced Practice Nurses (APN) intervention between the ambulatory hospitalization (AH) and the 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 | Interventional group |
Primary outcome
Blood pressure control
Time frame: Medical consultation, from 2 months to 12 months after inclusion
Blood pressure < 140/90 mmHg
6 secondary outcomes
Rate of patients who brought HBPM to consultation
Time frame: Medical consultation, from 2 months to 12 months after inclusion
Number of measurements
Time frame: Medical consultation, from 2 months to 12 months after inclusion
Rate of Blood pressure control
Time frame: Medical consultation, from 2 months to 12 months after inclusion
Rate of therapeutic adjustments
Time frame: Medical consultation, from 2 months to 12 months after inclusion
Rate of therapeutic adjustments
Time frame: Medical consultation, from 2 months to 12 months after inclusion
Rate of therapeutic adjustments
Time frame: Medical consultation, from 2 months to 12 months after inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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.
Jacques BLACHER, MD, PhD principal investigator
Diagnosis and Therapeutic Center, Hôtel-Dieu Hospital, Assistance Publique-Hôpitaux de Paris
Juliette VAY-DEMOUY, MSc, PhD study director
Diagnosis and Therapeutic Center, Hôtel-Dieu Hospital, Assistance Publique-Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APN intervention in people with 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 26 Jun 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juliette VAY-DEMOUY, MSc, PhD student (0033142348551, juliette.vaydemouy@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure control (time frame: Medical consultation, from 2 months to 12 months after inclusion). 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 26 Jun 2023.