Clinical trial NCT06748118: Improving Patients' Adherence to Their Chronic Treatments by Implementing a Simple, Standardized and Redundant Message Delivered by Healthcare Professionals.
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Disease
Therapeutic Adherence
Training Group, Sensitivity
Delivery Simple, Standardized & Redundant Message to Patient
Keywords: intervention study
stepped wedge study
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2024-12-27
Enrollment: 1210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The research is multicentric and randomized. The study intervention will be implemented in a stepped-wedge design with 10 steps, 10 healthcare facilities (clusters), 12 2-month periods, 1 2-month period including wash-out and training of healthcare professionals (intervention). The wash-out will prevent contamination between the two periods.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Improvement in therapeutic adherence
timeFrame: 6 months
Secondary outcomes:
measure: Improvement in therapeutic adherence
timeFrame: 12 months
measure: Predictive factors of improved adherence factors predictive of therapeutic adherence
timeFrame: 6 months
measure: Improvement in therapeutic adherence estimated
timeFrame: 12 months
measure: Costs of care according to periods (control vs. intervention)
timeFrame: 12 months
measure: Cost of the intervention
timeFrame: 12 months
measure: Satisfaction of participating healthcare professionals and reasons for refusal to participate
timeFrame: 12 months
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU d'Angers
city: Antibes
country: France
facility: CH d'Antibes
city: Issy-les-Moulineaux
country: France
facility: Hôpital Corentin Celton
city: Marseille
country: France
facility: Hôpital de la Conception
city: Marseille
country: France
facility: Hôpital La Timone
city: Nantes
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: Hôpital européen Georges-Pompidou
city: Paris
country: France
facility: Hôpital Bicêtre
city: Toulouse
country: France
facility: CHU de Toulouse
city: Tours
country: France
facility: CHU de Tours
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Brigitte SABATIER, Dr
role: PRINCIPAL_INVESTIGATOR
References: