Clinical trial NCT03963934: Feasibility of a Program on a Nurse-led Telephone 6-month-follow-up for Uncontrolled Hypertensive Women
Official title: Feasibility of a Program on a Nurse-led Telephone 6-month-follow-up for Uncontrolled Hypertensive Women: a Patient-tailored Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arterial Hypertension
Medication Nonadherence
Keywords: Nurse-led management
Home blood pressure
Nurse-led telephone follow-up
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2019-05-28
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, monocentric, open, pilot study
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of women who completed all telephone follow-ups and came to the final visit at 6 months.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CHRU Nancy
name: Edith DAUCHY, RN
role: PRINCIPAL_INVESTIGATOR
References: