Ignite Creation Date:
2024-05-06 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05917600
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-06-26
First Post:
2023-06-14
Brief Title:
Impact of Advanced Practical Nursing Intervention Versus Usual Care on Hypertension Control
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Impact of Advanced Practical Nursing Intervention Versus Usual Care on Hypertension Control Study Protocol for an Open-label Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
iIPA
Brief 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 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
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 appointments MD consultation - APN intervention at the end of the ambulatory hospitalization according to their allocation
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 appointments MD consultation - APN intervention at the end of the ambulatory hospitalization according to their allocation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A00189-36 | OTHER | ANSM | None |