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: a Patient-tailored Intervention

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.

Study Overview

• Status: Unknown
• Conditions: Arterial Hypertension; Medication Nonadherence
• Intervention / Treatment: Other: Program on a nurse-led telephone 6-month-follow-up for uncontrolled hypertensive women: a patient-tailored intervention

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: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Edith DAUCHY, RN, CHRU Nancy

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2019
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: May 23, 2019
• First Submitted That Met QC Criteria: May 24, 2019
• First Posted (Actual): May 28, 2019

Study Record Updates

• Last Update Posted (Actual): October 21, 2019
• Last Update Submitted That Met QC Criteria: October 17, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Home blood pressure; Nurse-led management; Nurse-led telephone follow-up
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 2019-A01921-56

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No