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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03963934
Other study ID # 2019-A01921-56
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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