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

NCT06748118 | Not Yet Recruiting

• 4 other identifiers: APHP230810PREPS-22-0004DR-2024-2712024-A00701-46
• Study Type: interventional
• Target: 1,210
• Locations: 1 country
• Sites: 10

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.

Conditions

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

Keywords

intervention study; stepped wedge study

Outcome Measures

Primary Outcomes (1)

• Improvement in therapeutic adherence

  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.

  6 months

Secondary Outcomes (6)

• 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

Study Arms (2)

Intervention period

EXPERIMENTAL

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.

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

Control period

NO INTERVENTION

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.

Interventions

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

Also known as: Intervention period

Intervention period

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Ministry of Health, France: collaborator

Study Sites (10)

CHU d'Angers

Angers, France, 49933, France

Location

CH d'Antibes

Antibes, France, 06606, France

Location

Hôpital Corentin Celton

Issy-les-Moulineaux, France, 92133, France

Location

Hôpital de la Conception

Marseille, France, 13005, France

Location

Hôpital La Timone

Marseille, France, 13005, France

Location

CHU de Nantes

Nantes, France, 44000, France

Location

Hôpital européen Georges-Pompidou

Paris, France, 75015, France

Location

Hôpital Bicêtre

Paris, France, 94270, France

Location

CHU de Toulouse

Toulouse, France, 31059, France

Location

CHU de Tours

Tours, France, 37000, France

Location

MeSH Terms

Conditions

Chronic Disease; Treatment Adherence and Compliance; Hypersensitivity

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Health Behavior; Behavior; Immune System Diseases

Study Officials

• Brigitte SABATIER, Dr

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiffany MARTIN

CONTACT

+33 1 44 84 17 92; tiffany.martin@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 27, 2024
• Study Start: February 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: December 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Two years after the last publication
• Access Criteria: Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. The founder could be involved in the decision. Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with European General Data Protection Regulation (GDPR).

Locations

FR (10)