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

NCT03963934 | Unknown

• 1 other identifier: 2019-A01921-56
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Arterial Hypertension; Medication Nonadherence

Keywords

Nurse-led management; Home blood pressure; Nurse-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

Program on a nurse-led telephone 6-month-follow-up for uncontrolled hypertensive women: a patient-tailored intervention OTHER

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

• Age: 18 Years - 79 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (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
• Inform 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

MeSH Terms

Conditions

Hypertension; Medication Adherence

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Edith DAUCHY, RN

  CHRU Nancy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edith DAUCHY, RN

CONTACT

33 3 83 15 73 13; e.dauchy@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, monocentric, open, pilot study

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: May 28, 2019
• Study Start: December 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: June 1, 2021
• Last Updated: October 21, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share