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TerminatedNCT03963934PreDynamiquesUpdated Jun 24, 2026

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

An interventional study of Program on a nurse-led telephone 6-month-follow-up for uncontrolled hypertensive women: a patient-tailored intervention in Arterial Hypertension and Medication Nonadherence, sponsored by Mme Edith DAUCHY. Terminated at 1 site in France. Open to female participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-06-24.

Sponsored by Mme Edith DAUCHY · Not applicable, Interventional, and Other

Why this study was terminated
100% screen failure
Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
18 Years to 79 Years
Sex
Female
01

Study 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.

Read the 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.
02

Conditions studied

  • Arterial Hypertension
  • Medication Nonadherence

Keywords

  • Nurse-led management
  • Home blood pressure
  • Nurse-led telephone follow-up
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 964 are open to participants now.

This study's enrollment of 14 is below the median of 90 across 4,994 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

This is the only study on the registry with Mme Edith DAUCHY as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
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 or greater than140 and / or diastolic BP equals to or greater than 90 mmHg at inclusion visit
  • Informed consent signed
  • Affiliation to a French social security scheme or beneficiary of such a scheme

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • 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

Interventions

  • OtherProgram 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)

06

What researchers measure

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).

    Time frame: 6 months

07

Study locations

1 site
  • CHRU Nancy / Centre Investigation Clinique Plurithématique
    Vandœuvre-lès-Nancy, Meurthe et Moselle 5450, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03963934
Lead sponsor
Mme Edith DAUCHY
Responsible party
Mme Edith DAUCHY (Mme, Central Hospital, Nancy, France) — Sponsor-investigator
First posted
May 28, 2019
Start date
Oct 31, 2020
Primary completion
Apr 28, 2022
Completion
Apr 28, 2022
Last update
Jun 24, 2026

Study contacts

Edith DAUCHY, RN
principal investigator · CHRU Nancy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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