Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-27 @ 11:34 PM
Study NCT ID:
NCT03963934
Status:
UNKNOWN
Last Update Posted:
2019-10-21
First Post:
2019-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of a Program on a Nurse-led Telephone 6-month-follow-up for Uncontrolled Hypertensive Women
Sponsor:
Central Hospital, Nancy, France
Organization:
Study Overview
Official Title:
Feasibility of a Program on a Nurse-led Telephone 6-month-follow-up for Uncontrolled Hypertensive Women: a Patient-tailored Intervention
Status:
UNKNOWN
Status Verified Date:
2019-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PreDynamiques
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: