NCT03963934

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 28, 2019

Completed
1.4 years until next milestone

Study Start

First participant enrolled

October 31, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2022

Completed
Last Updated

June 24, 2026

Status Verified

June 1, 2026

Enrollment Period

1.5 years

First QC Date

May 23, 2019

Last Update Submit

June 19, 2026

Conditions

Keywords

Nurse-led managementHome blood pressureNurse-led telephone follow-up

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Women with uncontrolled hypertension

EXPERIMENTAL

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

Interventions

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)

Women with uncontrolled hypertension

Eligibility Criteria

Age18 Years - 79 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Informed consent signed
  • Affiliation to a French social security scheme or beneficiary of such a scheme

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Nancy / Centre Investigation Clinique Plurithématique

Vandœuvre-lès-Nancy, Meurthe et Moselle, 5450, France

Location

MeSH Terms

Conditions

HypertensionMedication Adherence

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Edith DAUCHY, RN

    CHRU Nancy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Prospective, monocentric, open, pilot study
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Mme

Study Record Dates

First Submitted

May 23, 2019

First Posted

May 28, 2019

Study Start

October 31, 2020

Primary Completion

April 28, 2022

Study Completion

April 28, 2022

Last Updated

June 24, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations