Advanced Practice Nurse Intervention Versus Usual Care for Hypertension Control
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Interventional group After inclusion, eligible patients are randomly assigned to one of the following groups: the control group of patients keeps a traditional follow-up (AH then consultation with a MD within approximately two to six months) and the interventional group meets an APN between the AH and the MD consultation, within one to three months |
Behavioral: APN intervention
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 Intervention: Control group After inclusion, eligible patients are randomly assigned to one of the following groups: the control group of patients keeps a traditional follow-up (AH then consultation with a MD within approximately two to six months) and the interventional group meets an APN between the AH and the MD consultation, within one to three months |
Outcome Measures
Primary Outcome Measures
- Blood pressure control [3-6 months]
blood pressure <135/85mmHg
Secondary Outcome Measures
- Smoking status [3-6 months]
Smoking habits rate (smoker or non-smoker, expressed in percentage) reported by questionnaire (current or non-smoker information) will be used to assess this outcome
- Weight variations [3-6 months]
Weight levels (in kilograms) reported by tanita measurement will be used to assess this outcome
- Body mass index variations [3-6 months]
Body mass index (BMI) levels (BMI was: weight and height combination in kg/m2, weight and height reported by tanita measurement), will be used to assess this outcome
- Adherence to drug treatment [3-6 months]
Rate of adherence to drug treatment evaluated by the Girerd questionnaire (score : 0 to 3, where 0 is the lowest level and 3 the highest level; higher level means a better outcome) will be used to assess this outcome
- Tolerance to antihypertensive drugs [3-6 months]
Number of side effects reported by declarative information provided by patient will be used to assess this outcome
Eligibility Criteria
Criteria
Inclusion Criteria:
-
at least 18 years of age,
-
treated or untreated hypertension,
-
can to provide a written informed consent.
Exclusion Criteria:
-
patients with secondary hypertension,
-
age under 18 years old,
-
inability to give a free informed consent,
-
inability to speak or understand French properly.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hôpital Hôtel-Dieu | Paris | France |
Sponsors and Collaborators
- Hotel Dieu University Hospital, France
Investigators
- Principal Investigator: Juliette VAY-DEMOUY, Hôpital Universitaire Hôtel-Dieu; AP-HP; Université de Paris, France
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- APN