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

Primary Purpose

Arterial Hypertension, Medication Nonadherence

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Program on a nurse-led telephone 6-month-follow-up for uncontrolled hypertensive women: a patient-tailored intervention
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Arterial Hypertension focused on measuring Nurse-led management, Home blood pressure, Nurse-led telephone follow-up

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Women with uncontrolled hypertension

    Arm Description

    Women with uncontrolled hypertension and unsatisfactory medication adherence

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    Full Information

    First Posted
    May 23, 2019
    Last Updated
    October 17, 2019
    Sponsor
    Central Hospital, Nancy, France
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03963934
    Brief Title
    Feasibility of a Program on a Nurse-led Telephone 6-month-follow-up for Uncontrolled Hypertensive Women
    Acronym
    PreDynamiques
    Official Title
    Feasibility of a Program on a Nurse-led Telephone 6-month-follow-up for Uncontrolled Hypertensive Women: a Patient-tailored Intervention
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 1, 2019 (Anticipated)
    Primary Completion Date
    December 1, 2020 (Anticipated)
    Study Completion Date
    June 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Central Hospital, Nancy, France

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    Detailed Description
    The program includes 2 themes: "Realizing my blood pressure self-measurement" according to the recommendations "Optimizing my compliance": understand the antihypertensive treatment, identify the brakes and the levers when taking medication, organize the treatment taking Visits : 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 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 Final visit at 6-month : Same as the inclusion visit with assessment of the support and questionnaire to assess the patient satisfaction level.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Arterial Hypertension, Medication Nonadherence
    Keywords
    Nurse-led management, Home blood pressure, Nurse-led telephone follow-up

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Prospective, monocentric, open, pilot study
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Women with uncontrolled hypertension
    Arm Type
    Experimental
    Arm Description
    Women with uncontrolled hypertension and unsatisfactory medication adherence
    Intervention Type
    Other
    Intervention Name(s)
    Program on a nurse-led telephone 6-month-follow-up for uncontrolled hypertensive women: a patient-tailored intervention
    Intervention Description
    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)
    Primary Outcome Measure Information:
    Title
    Proportion of women who completed all telephone follow-ups and came to the final visit at 6 months.
    Description
    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).
    Time Frame
    6 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    79 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Edith DAUCHY, RN
    Phone
    33 3 83 15 73 13
    Email
    e.dauchy@chru-nancy.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Edith DAUCHY, RN
    Organizational Affiliation
    CHRU Nancy
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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