HypertensionNCT04448249
Advanced Practice Nurse Intervention Versus Usual Care for Hypertension Control
A study testing APN intervention in people with Hypertension, run by Hotel Dieu University Hospital, France 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
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2023to 31 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 18 years of age,
- treated or untreated hypertension,
- can to provide a written informed consent.
Who cannot join
- age under 18 years old,
- inability to give a free informed consent.
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Hôtel-Dieu
Paris
Juliette VAY-DEMOUY, 0142348551, juliette.vaydemouy@aphp.fr
Jacques BLACHER, 0142348966, jacques.blacher@aphp.fr
About this study
Official title: Advanced Practice Nurse Intervention Versus Usual Care for 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. 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.
The patients will be recruited during their visit at the day hospitalization of the Diagnosis and Therapeutic Center of Hôtel-Dieu University Hospital, for hypertension-related complications and cardiovascular risk assessment as part of their hypertension management.
Randomization/allocation will be conducted at the last moment before scheduling appointments.
The "usual care" group will keep a traditional follow-up: day hospitalization then consultation with a MD within approximately 2 to 12 months.
The "intervention" group will meet the APN between the day hospitalization and the MD consultation, within 1 to 6 months (Figure 1).
All data will be collected on site, none remotely. All information required by the protocol will be recorded on a case report form. An explanation will be provided for each missing data. The data will be collected as it is obtained and clearly transcribed into the case report form.
The primary outcome measure will be analyzed using a chi-square test. A p value <0.05 will be considered significant. Participants with missing data for this primary outcome will be considered lost to follow-up. For secondary outcome measures, a chi-square test will be used for qualitative variables compared between the two groups. A paired t-tests will be used for the differences of rate of controlled blood pressure between day hospitalization and MD consultation in each group. Non-adherent participants (APN intervention missed for the interventional group) will be considered in the statistical analysis and the rate of non-adherent participants will be mentioned in the results.Correlations between the realization and the quality of home BP monitoring in MD consultation and controlled BP will also be analyzed. No interim analyses are scheduled.
- Conditions
- Hypertension
- Being tested
- APN intervention
- Keywords
- Advanced Pratice Nurse, Hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APN interventionBehavioural
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 keeps a traditional follow up (day hospitalization then consultation with a MD within two to twelve months) but also meets an APN between the day hospitalization and the MD consultation, within one to six months Receives: Behavioral: APN intervention |
| Control group | No intervention | The control group of patients keeps a traditional follow-up: day hospitalization then consultation with a MD within two to twelve months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of controlled blood pressure in MD consultation (office blood pressure < 140/90 mmHg)
According to the European and International guidelines, the protocol for office BP measurement will be: 5 minutes rest, 3 measurements at one-minute intervals in supine position followed by 3 standing measurements at one-minute intervals for orthostatic hypotension test. Unattended office blood pressure measurement will be conducted thanks to a supervisor (usually a nurse) who will explain the protocol to the patient before letting him rest in a quiet room and thanks to an automatic sphygmomanometer that can print the statement of measures at the end of the monitoring. Blood pressure level will be estimated by the average of the 2 last blood pressure measures in supine position. We will consider that blood pressure is controlled if systolic blood pressure < 140 mmHg and diastolic blood pressure < 90 mmHg.
Measured: 12 months
Secondary outcomes (5)
Rate of home blood pressure monitoring brought to MD consultation
According to the 2020 International Society of Hypertension (ISH) Global Hypertension Practice Guidelines, the protocol for home BP monitoring will be: 3-day monitoring with a cycle of 3 measures every morning and every evening at one-minute intervals, in a sitting position, after 5 minutes of rest and before meals.
Measured: 12 months
Quality of the home blood pressure monitoring brought to MD consultation
The quality will be assessed by the number of measurements (18 measurements over 3 days according to the protocol).
Measured: 12 months
Rate of therapeutic adjustments during the APN intervention
Rate of therapeutic adjustments among the interventional group during the APN intervention.
Measured: 6 months
Indication(s) of therapeutic adjustments during the APN intervention
Rate of therapeutic adjustments due to lack of efficacy and/or intolerance among the interventional group during the APN intervention.
Measured: 6 months
Difference in rates of controlled blood pressure (office blood pressure < 140/90 mmHg) between day hospitalization and MD consultation in each group.
Evolution of the rate of controlled blood pressure between day hospitalization and MD consultation in each group.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start1 Nov 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hotel Dieu University Hospital, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacques Blacher, Hotel Dieu University Hospital, France
- Investigators
- Juliette VAY-DEMOUY, Principal investigator, Hôpital Universitaire Hôtel-Dieu; AP-HP; Université de Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04448249
- Sponsor's protocol ID
- APN
- Status last verified
- Sep 2023
- First submitted
- 16 Jun 2020
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Practice Nurse Intervention Versus Usual Care for Hypertension Control: Study Protocol for an Open-label Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04448249
- Acronym / sponsor ID
- APN
- Conditions
- Hypertension
- Keywords
- Advanced Pratice Nurse, Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Hotel Dieu University Hospital, FranceUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 25 Jun 2020 (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.
The patients will be recruited during their visit at the day hospitalization of the Diagnosis and Therapeutic Center of Hôtel-Dieu University Hospital, for hypertension-related complications and cardiovascular risk assessment as part of their hypertension management.
Randomization/allocation will be conducted at the last moment before scheduling appointments.
The "usual care" group will keep a traditional follow-up: day hospitalization then consultation with a MD within approximately 2 to 12 months.
The "intervention" group will meet the APN between the day hospitalization and the MD consultation, within 1 to 6 months (Figure 1).
All data will be collected on site, none remotely. All information required by the protocol will be recorded on a case report form. An explanation will be provided for each missing data. The data will be collected as it is obtained and clearly transcribed into the case report form.
The primary outcome measure will be analyzed using a chi-square test. A p value <0.05 will be considered significant. Participants with missing data for this primary outcome will be considered lost to follow-up. For secondary outcome measures, a chi-square test will be used for qualitative variables compared between the two groups. A paired t-tests will be used for the differences of rate of controlled blood pressure between day hospitalization and MD consultation in each group. Non-adherent participants (APN intervention missed for the interventional group) will be considered in the statistical analysis and the rate of non-adherent participants will be mentioned in the results.Correlations between the realization and the quality of home BP monitoring in MD consultation and controlled BP will also be analyzed. No interim analyses are scheduled.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Behavioral: APN interventionThe interventional group keeps a traditional follow up (day hospitalization then consultation with a MD within two to twelve months) but also meets an APN between the day hospitalization and the MD consultation, within one to six months |
| Control group | No intervention | –The control group of patients keeps a traditional follow-up: day hospitalization then consultation with a MD within two to twelve months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- at least 18 years of age,
- treated or untreated hypertension,
- can to provide a written informed consent.
Key exclusion criteria (2 listed)
- age under 18 years old,
- inability to give a free informed consent.
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 interventionAPN 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. | Behavioural | Interventional group |
Primary outcome
Rate of controlled blood pressure in MD consultation (office blood pressure < 140/90 mmHg)
Time frame: 12 months
According to the European and International guidelines, the protocol for office BP measurement will be: 5 minutes rest, 3 measurements at one-minute intervals in supine position followed by 3 standing measurements at one-minute intervals for orthostatic hypotension test. Unattended office blood pressure measurement will be conducted thanks to a supervisor (usually a nurse) who will explain the protocol to the patient before letting him rest in a quiet room and thanks to an automatic sphygmomanometer that can print the statement of measures at the end of the monitoring. Blood pressure level will be estimated by the average of the 2 last blood pressure measures in supine position. We will consider that blood pressure is controlled if systolic blood pressure < 140 mmHg and diastolic blood pressure < 90 mmHg.
5 secondary outcomes
Rate of home blood pressure monitoring brought to MD consultation
Time frame: 12 months
Quality of the home blood pressure monitoring brought to MD consultation
Time frame: 12 months
Rate of therapeutic adjustments during the APN intervention
Time frame: 6 months
Indication(s) of therapeutic adjustments during the APN intervention
Time frame: 6 months
Difference in rates of controlled blood pressure (office blood pressure < 140/90 mmHg) between day hospitalization and MD consultation in each group.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
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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.
Juliette VAY-DEMOUY principal investigator
Hôpital Universitaire Hôtel-Dieu; AP-HP; Université de Paris, France
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 Hotel Dieu University Hospital, France 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 22 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juliette VAY-DEMOUY (0142348551, juliette.vaydemouy@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of controlled blood pressure in MD consultation (office blood pressure < 140/90 mmHg) (time frame: 12 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 22 Sep 2023.