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Clinical Trials/NCT06748118
NCT06748118
Not Yet Recruiting
N/A

Improving Patients' Adherence to Their Chronic Treatments by Implementing a Simple, Standardized and Redundant Message Delivered by Healthcare Professionals: a Stepped-wedge Multicenter Randomized Trial

Assistance Publique - Hôpitaux de Paris10 sites in 1 country1,210 target enrollmentFebruary 2025

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Disease
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
1210
Locations
10
Primary Endpoint
Improvement in therapeutic adherence
Status
Not Yet Recruiting
Last Updated
last year

Overview

Brief Summary

The primary objective in this study is to achieve a 15% 6-month improvement in therapeutic adherence among patients with chronic pathologies, thanks to a simple, standardized and redundant message delivered by healthcare professionals during consultations/interviews Trained healthcare professionals deliver a simple, standardized and redundant 3-point message to patients, based on the levers of action concerning therapeutic adherence. This message is delivered with the aim of modifying the patient's behavior with regard to treatment intake.

Detailed Description

This project will enable us to adapt or even modify the practices of healthcare professionals, by making management recommendations to improve patients' adherence to treatment during their consultations/interviews, and throughout their entire course of care. This project will increase the benefit/risk ratio of treatments and reduce the waste of healthcare resources. For patients, their participation by filling in the therapeutic adherence self-questionnaire will enable them to become active players in the management of their treatment. If the results of our study prove positive, this will lead to a new, optimized organization of patient care.

Registry
clinicaltrials.gov
Start Date
February 2025
End Date
February 2028
Last Updated
last year
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adult patients (age ≥ 18 years)
  • Affiliated to the French social security system
  • Followed in hospital for a chronic pathology within a formalized care pathway
  • Having signed a consent form to participate in the study.

Exclusion Criteria

  • Patients included in the control period.
  • Patients under guardianship.
  • Pregnant or breast-feeding patients.
  • Patients taking part in research on compliance

Outcomes

Primary Outcomes

Improvement in therapeutic adherence

Time Frame: 6 months

The medication possession ratio (MPR), calculated as the ratio between the sum of treatment days delivered over the period of interest x 100, expressed as a %. In the literature, an MPR ≥ 80% corresponds to good therapeutic adherence.

Secondary Outcomes

  • Improvement in therapeutic adherence(12 months)
  • Predictive factors of improved adherence factors predictive of therapeutic adherence(6 months)
  • Improvement in therapeutic adherence estimated(12 months)
  • Costs of care according to periods (control vs. intervention)(12 months)
  • Cost of the intervention(12 months)
  • Satisfaction of participating healthcare professionals and reasons for refusal to participate(12 months)

Study Sites (10)

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