Feasibility of a Program on a Nurse-led Telephone 6-month-follow-up for Uncontrolled Hypertensive Women (PreDynamiques)

Central Hospital, Nancy, France

Status: Unknown

Conditions: Medication Nonadherence; Arterial Hypertension

Treatments: Other: Program on a nurse-led telephone 6-month-follow-up for uncontrolled hypertensive women: a patient-tailored intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03963934

2019-A01921-56

Details and patient eligibility

About

This study evaluate the feasibility of a 6-month personalized support program for hypertensive and non-observant women, led by nurses by telephone follow-up.

Full description

The program includes 2 themes:

1. "Realizing my blood pressure self-measurement" according to the recommendations
2. "Optimizing my compliance": understand the antihypertensive treatment, identify the brakes and the levers when taking medication, organize the treatment taking

Visits :

1. Inclusion visit :

   • Collection of consent by the nurse
   • Verification of inclusion and non-inclusion criteria : measurement of compliance with a scale for each antihypertensive treatment and BP measurement
   • Data collection and goal setting
   • Urine collection for dosing anti-hypertension drugs
   • Delivery of the schedule of telephone visits that were determined with the patient

2. Implementation of personalized support with the following steps :

   • Data collection : evaluate knowledge and its potential as a patient, identify his needs
   • Determination of objectives : define the objectives of the program in each theme with the patient according to the collection of data Implementation of personalized support
   • 7 telephone interviews of 20 to 30 minutes use of specific teaching tools and materials by thematic assessment of achievements, validation of objectives

   Evaluation of the accompaniment:

   • assessment at the final visit

3. Final visit at 6-month : Same as the inclusion visit with assessment of the support and questionnaire to assess the patient satisfaction level.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Woman ≥ 18 to 79 years old,
• Hypertensive and treated with antihypertensive drug(s)
• Unsatisfactory compliance for at least one of her antihypertensive treatment with a score below 80% at the medication adherence scale
• Uncontrolled Blood Pressure (BP) : systolic BP equals to ou greater than140 and / or diastolic BP equals to ou greater than 90 mmHg at inclusion visit
• Inform consent signed
• Affiliation to a French social security scheme or beneficiary of such a scheme

Exclusion criteria

• Patient with a history of cardio or cerebrovascular disease in the last 6 months (Stroke or Transient Ischemic Attack, myocardial infarction, heart failure)
• Patient with kidney failure requiring dialysis
• Patient with cognitive pathology: dementia, ... etc.
• Patient with type I diabetes
• Unreachable patient by phone or foreseeable inability or unwillingness to comply with study follow-up
• Patient who does not understand and does not speak French

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

Women with uncontrolled hypertension

Experimental group

Description:

Women with uncontrolled hypertension and unsatisfactory medication adherence

Treatment:

Other: Program on a nurse-led telephone 6-month-follow-up for uncontrolled hypertensive women: a patient-tailored intervention