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

Not Applicable

• Conditions: Medication Nonadherence; Arterial Hypertension

• Registration Number: NCT03963934
• Lead Sponsor: Central Hospital, Nancy, France

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.

Study Timeline

• Study First Submitted: 2019-05-23
• Study First Submitted QC: 2019-05-24
• Study First Posted: 2019-05-28
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-17
• Last Update Posted: 2019-10-21
• Study Start: 2019-12-01
• Primary Completion: 2020-12-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Proportion of women who completed all telephone follow-ups and came to the final visit at 6 months.	6 months	The goal of recruitment in 6 months will be 20 women and the goal of the program finalization will be of at least 80% of patients (16 patients).