- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04448249
Advanced Practice Nurse Intervention Versus Usual Care for Hypertension Control
Advanced Practice Nurse Intervention Versus Usual Care for Hypertension Control: Study Protocol for an Open-label Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Juliette VAY-DEMOUY
- Phone Number: 0142348551
- Email: juliette.vaydemouy@aphp.fr
Study Contact Backup
- Name: Jacques BLACHER
- Phone Number: 0142348966
- Email: jacques.blacher@aphp.fr
Study Locations
-
-
-
Paris, France
- Hôpital Hôtel-Dieu
-
Contact:
- Juliette VAY-DEMOUY
- Phone Number: 0142348551
- Email: juliette.vaydemouy@aphp.fr
-
Contact:
- Jacques BLACHER
- Phone Number: 0142348966
- Email: jacques.blacher@aphp.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- at least 18 years of age,
- treated or untreated hypertension,
- can to provide a written informed consent.
Exclusion Criteria:
- age under 18 years old,
- inability to give a free informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Interventional group
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
|
APN intervention is divided into five main steps:
|
No Intervention: Control group
The control group of patients keeps a traditional follow-up: day hospitalization then consultation with a MD within two to twelve months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of home blood pressure monitoring brought to MD consultation
Time Frame: 12 months
|
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.
|
12 months
|
Quality of the home blood pressure monitoring brought to MD consultation
Time Frame: 12 months
|
The quality will be assessed by the number of measurements (18 measurements over 3 days according to the protocol).
|
12 months
|
Rate of therapeutic adjustments during the APN intervention
Time Frame: 6 months
|
Rate of therapeutic adjustments among the interventional group during the APN intervention.
|
6 months
|
Indication(s) of therapeutic adjustments during the APN intervention
Time Frame: 6 months
|
Rate of therapeutic adjustments due to lack of efficacy and/or intolerance among the interventional group during the APN intervention.
|
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
|
Evolution of the rate of controlled blood pressure between day hospitalization and MD consultation in each group.
|
12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Juliette VAY-DEMOUY, Hôpital Universitaire Hôtel-Dieu; AP-HP; Université de Paris, France
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- APN
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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