Study Stopped
100% screen failure
Feasibility of a Program on a Nurse-led Telephone 6-month-follow-up for Uncontrolled Hypertensive Women
PreDynamiques
1 other identifier
interventional
14
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2019
CompletedFirst Posted
Study publicly available on registry
May 28, 2019
CompletedStudy Start
First participant enrolled
October 31, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 28, 2022
CompletedJune 24, 2026
June 1, 2026
1.5 years
May 23, 2019
June 19, 2026
Conditions
Keywords
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
EXPERIMENTALWomen with uncontrolled hypertension and unsatisfactory medication adherence
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)
Eligibility Criteria
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
- Mme Edith DAUCHYlead
Study Sites (1)
CHRU Nancy / Centre Investigation Clinique Plurithématique
Vandœuvre-lès-Nancy, Meurthe et Moselle, 5450, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edith DAUCHY, RN
CHRU Nancy
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- 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