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

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Unknown status
CT.gov ID
NCT03963934
Collaborator
(none)
40
Enrollment
1
Arm
18
Anticipated Duration (Months)

Study Details

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
  • Other: Program on a nurse-led telephone 6-month-follow-up for uncontrolled hypertensive women: a patient-tailored intervention
 N/A

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

  1. 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
  1. 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

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Prospective, monocentric, open, pilot studyProspective, 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
Anticipated Study Start Date :
Dec 1, 2019
Anticipated Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Jun 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. [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

Criteria

Ages Eligible for Study:
18 Years to 79 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

Sponsors and Collaborators

  • Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Edith DAUCHY, RN, CHRU Nancy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT03963934
Other Study ID Numbers:
  • 2019-A01921-56
First Posted:
May 28, 2019
Last Update Posted:
Oct 21, 2019
Last Verified:
Oct 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Central Hospital, Nancy, France
Nurse-led management
Home blood pressure
Nurse-led telephone follow-up
Additional relevant MeSH terms:
Hypertension

Study Results

No Results Posted as of Oct 21, 2019