AzTrials
AzTrials

Chronic DiseaseMAPSNCT06748118

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

A study testing Trained healthcare professionals deliver a simple, standardized and redundant 3-point message to patients, based on the levers of action for therapeutic adherence. in people with Chronic Disease and Therapeutic Adherence, run by Assistance Publique - Hôpitaux de Paris at 10 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Trained healthcare professionals deliver a simple, standardized and redundant 3-point message to patients, based on the levers of action for therapeutic adherence.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,210 participants
Where
10 sitesFrance
Study dates
18 Mar 2026to Mar 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Tiffany MARTIN contact

+33 1 44 84 17 92

tiffany.martin@aphp.fr

10 sites in 1 country

France10 sites, 10 recruiting

  • CHU d'Angers

    Angers, France, 49933

    Laurence SPIESSER-ROBELET, Dr, +33 2 41 35 35 44, laspiesser-robelet@chu-angers.fr

    Recruiting

  • CH d'Antibes

    Antibes, France, 06606

    Benjamin VERRIERE, Dr, +33 4 97 24 77 41, benjamin.verriere@ch-antibes.fr

    Recruiting

  • Hôpital Corentin Celton

    Issy-les-Moulineaux, France, 92133

    Yann ORVEN, Dr, +33 1 58 00 46 30, yann.orven@aphp.fr

    Recruiting

  • Hôpital de la Conception

    Marseille, France, 13005

    Florian CORREARD, Dr, +33 4 91 38 43 97, florian.correard@ap-hm.fr

    Recruiting

  • Hôpital La Timone

    Marseille, France, 13005

    Guillaume HACHE, Dr, +33 4 91 38 70 66, guillaume.hache@ap-hm.fr

    Recruiting

  • CHU de Nantes

    Nantes, France, 44000

    Jean-François HUON, Dr, +33 2 44 76 80 74, jeanfrancois.huon@chu-nantes.fr

    Recruiting

  • Hôpital européen Georges-Pompidou

    Paris, France, 75015

    Brigitte SABATIER, Dr, +33 1 56 09 31 54, brigitte.sabatier@aphp.fr

    Recruiting

  • Hôpital Bicêtre

    Paris, France, 94270

    Marie-Camille CHAUMAIS, Dr, +33 1 45 21 71 72, marie-camille.chaumais@aphp.fr

    Recruiting

  • CHU de Toulouse

    Toulouse, France, 31059

    Philippe CESTAC, Dr, +33 5 67 77 11 59, cestac.p@chu-toulouse.fr

    Recruiting

  • CHU de Tours

    Tours, France, 37000

    Laura FOUCAULT-FRUCHARD, Dr, +33 2 47 47 38 89, l.foucaultfruchard@chu-tours.fr

    Recruiting

Other trials in France

About this study

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

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.

Read the 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.

Being tested
Trained healthcare professionals deliver a simple, standardized and redundant 3-point message to patients, based on the levers of action for therapeutic adherence.
Keywords
intervention study, stepped wedge study
Medical subject headings
Chronic Disease, Treatment Adherence and Compliance, Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called Intervention period

    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.

Study groups in NCT06748118
Study groupRoleWhat they receive
Intervention periodExperimentalTrained 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.
Receives: 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 periodNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Secondary outcomes (6)

  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 %.

    Measured: 12 months

  2. Predictive factors of improved adherence factors predictive of therapeutic adherence

    Identification of predictive factors for improving adherence assessed by the Freedom patient self-questionnaire and known factors.

    Measured: 6 months

  3. Improvement in therapeutic adherence estimated

    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.

    Measured: 12 months

  4. Costs of care according to periods (control vs. intervention)

    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.

    Measured: 12 months

  5. Cost of the intervention

    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.

    Measured: 12 months

  6. Satisfaction of participating healthcare professionals and reasons for refusal to participate

    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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2024
  2. Study start18 Mar 2026
  3. Primary completionMar 2028 (estimated)
  4. Study completionMar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Sequential
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06748118
Sponsor's protocol ID
APHP230810
Other IDs
PREPS-22-0004, DR-2024-271, 2024-A00701-46
Acronym
MAPS
Status last verified
Jun 2026
First submitted
5 Dec 2024
Last updated
1 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

Questions about this trial

What is this clinical trial studying?

A study testing Trained healthcare professionals deliver a simple, standardized and redundant 3-point message to patients, based on the levers of action for therapeutic adherence. in people with Chronic Disease and Therapeutic Adherence, run by Assistance Publique - Hôpitaux de Paris at 10 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tiffany MARTIN (+33 1 44 84 17 92, tiffany.martin@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement in therapeutic adherence (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06748118.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.

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