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

NCT ID: NCT03963934

Last Updated: 2019-10-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2021-06-01

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.

Conditions

Arterial Hypertension; Medication Nonadherence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Women with uncontrolled hypertension

Women with uncontrolled hypertension and unsatisfactory medication adherence

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

Implementation of personalized support: The accompaniment includes 7 telephone interviews for 6 months (understanding the antihypertensive treatment, identifying the brakes and the levers when taking medication, organizing the treatment taking, making the home blood pressure)

Interventions

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

Implementation of personalized support: The accompaniment includes 7 telephone interviews for 6 months (understanding the antihypertensive treatment, identifying the brakes and the levers when taking medication, organizing the treatment taking, making the home blood pressure)

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edith DAUCHY, RN

Role: PRINCIPAL_INVESTIGATOR

CHRU Nancy

Central Contacts

Edith DAUCHY, RN

Role: CONTACT

e.dauchy@chru-nancy.fr

33 3 83 15 73 13

Other Identifiers

2019-A01921-56

Identifier Type: -

Identifier Source: org_study_id