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出境医 / 临床实验 / Feasibility of a Program on a Nurse-led Telephone 6-month-follow-up for Uncontrolled Hypertensive Women (PreDynamiques)

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

Study Description
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.

Condition or disease Intervention/treatment Phase
Arterial Hypertension Medication Nonadherence Other: Program on a nurse-led telephone 6-month-follow-up for uncontrolled hypertensive women: a patient-tailored intervention Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, monocentric, open, pilot study
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Feasibility of a Program on a Nurse-led Telephone 6-month-follow-up for Uncontrolled Hypertensive Women: a Patient-tailored Intervention
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : June 1, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Women with uncontrolled hypertension
Women with uncontrolled hypertension and unsatisfactory medication adherence
 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)
Outcome Measures
Primary Outcome Measures :
  1. Proportion of women who completed all telephone follow-ups and came to the final visit at 6 months. [ Time Frame: 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Contacts
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Contact: Edith DAUCHY, RN 33 3 83 15 73 13 e.dauchy@chru-nancy.fr

Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Edith DAUCHY, RN CHRU Nancy
Tracking Information
First Submitted Date  ICMJE May 23, 2019
First Posted Date  ICMJE May 28, 2019
Last Update Posted Date October 21, 2019
Estimated Study Start Date  ICMJE December 1, 2019
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2019) 		Proportion of women who completed all telephone follow-ups and came to the final visit at 6 months. [ Time Frame: 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).
Original Primary Outcome Measures  ICMJE
 (submitted: May 24, 2019) 		Proportion of women who completed all telephone follow-ups and came to the final visit at 6 months. [ Time Frame: 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility of a Program on a Nurse-led Telephone 6-month-follow-up for Uncontrolled Hypertensive Women
Official Title  ICMJE Feasibility of a Program on a Nurse-led Telephone 6-month-follow-up for Uncontrolled Hypertensive Women: a Patient-tailored Intervention
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Prospective, monocentric, open, pilot study
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Arterial Hypertension
  • Medication Nonadherence
Intervention  ICMJE 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)
Study Arms  ICMJE Experimental: Women with uncontrolled hypertension
Women with uncontrolled hypertension and unsatisfactory medication adherence
Intervention: Other: Program on a nurse-led telephone 6-month-follow-up for uncontrolled hypertensive women: a patient-tailored intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 24, 2019) 		40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2021
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Edith DAUCHY, RN 33 3 83 15 73 13 e.dauchy@chru-nancy.fr
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03963934
Other Study ID Numbers  ICMJE 2019-A01921-56
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Central Hospital, Nancy, France
Study Sponsor  ICMJE Central Hospital, Nancy, France
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Edith DAUCHY, RN CHRU Nancy
PRS Account Central Hospital, Nancy, France
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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