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

Arterial Hypertension Clinical Trial

— PreDynamiques  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03963934
• Other study ID #: 2019-A01921-56
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: June 1, 2021

Study information

• Verified date: October 2019
• Source: Central Hospital, Nancy, France
• Contact: Edith DAUCHY, RN
• Phone: 33 3 83 15 73 13
• Email: e.dauchy[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Arterial Hypertension
• Hypertension
• Medication Nonadherence

Intervention

Other:
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of women who completed all telephone follow-ups and came to the final visit at 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).	6 months