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

NCT ID: NCT06748118

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

1210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-28

Study Completion Date

2028-02-29

Brief Summary

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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

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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.

Conditions

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

Keywords

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intervention study stepped wedge study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention period

Trained healthcare professionals deliver a simple, standardized and redundant 3-point message to patients, based on the levers of action for therapeutic adherence.

During this period, the message will be delivered to the patient by each of the healthcare professionals involved in his or her hospital care. It will be formalized by a checklist that will enable them to reformulate the 3 points defined as key elements of therapeutic adherence. Each healthcare professional is free to deliver this message at any time during their consultation/interview with the patient. They will be asked to note the date and tick off each point on the checklist.

The intervention period will take place after the control and wash-out periods, and after healthcare professionals have been trained in the intervention.

Group Type EXPERIMENTAL

Trained healthcare professionals deliver a simple, standardized and redundant 3-point message to patients, based on the levers of action for therapeutic adherence.

Intervention Type OTHER

This message is delivered with the aim of modifying the patient's behavior with regard to treatment intake. The research does not anticipate any change in the patient's medical prescriptions.

Control period

The control period is the period before healthcare professionals are trained in the intervention. Patients included during this period will not receive the simple, standardized and redundant message.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Trained healthcare professionals deliver a simple, standardized and redundant 3-point message to patients, based on the levers of action for therapeutic adherence.

This message is delivered with the aim of modifying the patient's behavior with regard to treatment intake. The research does not anticipate any change in the patient's medical prescriptions.

Intervention Type OTHER

Other Intervention Names

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Intervention period

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brigitte SABATIER, Dr

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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CHU d'Angers

Angers, France, France

Site Status

CH d'Antibes

Antibes, France, France

Site Status

Hôpital Corentin Celton

Issy-les-Moulineaux, France, France

Site Status

Hôpital de la Conception

Marseille, France, France

Site Status

Hôpital La Timone

Marseille, France, France

Site Status

CHU de Nantes

Nantes, France, France

Site Status

Hôpital européen Georges-Pompidou

Paris, France, France

Site Status

Hôpital Bicêtre

Paris, France, France

Site Status

CHU de Toulouse

Toulouse, France, France

Site Status

CHU de Tours

Tours, France, France

Site Status

Countries

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France

Central Contacts

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Tiffany MARTIN

Role: CONTACT

Phone: +33 1 44 84 17 92

Email: [email protected]

Facility Contacts

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Laurence SPIESSER-ROBELET, Dr

Role: primary

Benjamin VERRIERE, Dr

Role: primary

Yann ORVEN, Dr

Role: primary

Florian CORREARD, Dr

Role: primary

Guillaume HACHE, Dr

Role: primary

Jean-François HUON, Dr

Role: primary

Brigitte SABATIER, Dr

Role: primary

Marie-Camille CHAUMAIS, Dr

Role: primary

Philippe CESTAC, Dr

Role: primary

Laura FOUCAULT-FRUCHARD, Dr

Role: primary

Other Identifiers

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PREPS-22-0004

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

DR-2024-271

Identifier Type: OTHER

Identifier Source: secondary_id

2024-A00701-46

Identifier Type: OTHER

Identifier Source: secondary_id

APHP230810

Identifier Type: -

Identifier Source: org_study_id