Improving Patients' Adherence to Their Chronic Treatments by Implementing a Simple, Standardized and Redundant Message Delivered by Healthcare Professionals.

Not Applicable

Not yet recruiting

• Conditions: Chronic Disease; Therapeutic Adherence; Training Group, Sensitivity; Delivery Simple, Standardized & Redundant Message to Patient

• Registration Number: NCT06748118
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-12-05
• Study First Submitted QC: 2024-12-20
• Last Update Submitted: 2024-12-20
• Study First Posted: 2024-12-27
• Last Update Posted: 2024-12-27
• Study Start: 2025-02
• Primary Completion: 2027-08
• Study Completion: 2028-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1210

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Improvement in therapeutic adherence	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 Outcome Measures

Name	Time	Method
Improvement in therapeutic adherence	12 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 %.
Predictive factors of improved adherence factors predictive of therapeutic adherence	6 months	Identification of predictive factors for improving adherence assessed by the Freedom patient self-questionnaire and known factors.
Improvement in therapeutic adherence estimated	12 months	patient adherence self-questionnaire, taking into account what the patient says between M0 and M3, M3 and M6; and between M0 and M12, M6 and M12 (11 questions formulated using a 5-point Likert scale), which classifies patients' therapeutic adherence into 3 classes: "low therapeutic adherence / average / high". Improvement in adherence will be assessed by changing the adherence category.
Costs of care according to periods (control vs. intervention)	12 months	The number of consultations (general practitioner, specialist, nurse), hospital admissions (day and conventional), emergency room visits, and the number and duration of days off work will be collected prospectively via a questionnaire on the evaluation of healthcare use given to the patient at M0, M3, M6 and M12. Costs will then be evaluated using the official tariffs for each procedure or hospitalization. Treatment costs will be evaluated on the basis of data from copies of prescriptions collected by pharmacists at each center.
Cost of the intervention	12 months	a comparison of the cost of the intervention in terms of time spent on training by healthcare professionals and delivery of the 3-point message for each patient will be carried out, compared with the control group.
Satisfaction of participating healthcare professionals and reasons for refusal to participate	12 months	Numbers and percentages will be reported for each question of the professional satisfaction self-questionnaire adapted from Jean-Marc Palm questionnaire. The questionnaire contains six questions. The answers range from totally disagree to totally agree.

Trial Locations

Locations (10)

Hôpital La Timone; 🇫🇷 Marseille, France

CHU d'Angers; 🇫🇷 Angers, France

CH d'Antibes; 🇫🇷 Antibes, France

Hôpital Corentin Celton; 🇫🇷 Issy-les-Moulineaux, France

Hôpital de la Conception; 🇫🇷 Marseille, France

CHU de Nantes; 🇫🇷 Nantes, France

Hôpital européen Georges-Pompidou; 🇫🇷 Paris, France

Hôpital Bicêtre; 🇫🇷 Paris, France

CHU de Toulouse; 🇫🇷 Toulouse, France

CHU de Tours; 🇫🇷 Tours, France