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.
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
- Conditions the study is for
- Chronic Disease, Therapeutic Adherence, Training Group, Sensitivity
- 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.
10 sites in 1 country
France10 sites, 10 recruiting
- 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
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.
- Conditions
- Chronic Disease, Therapeutic Adherence, Training Group, Sensitivity, Delivery Simple, Standardized & Redundant Message to Patient
- 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 group | Role | What they receive |
|---|---|---|
| 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. 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 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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.
- First posted27 Dec 2024
- Study start18 Mar 2026
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Brigitte SABATIER, Dr, Principal investigator, Assistance Publique - Hôpitaux de Paris
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06748118
- Acronym / sponsor ID
- MAPS / APHP230810
- Conditions
- Chronic Disease, Therapeutic Adherence, Training Group, Sensitivity, Delivery Simple, Standardized & Redundant Message to Patient
- Keywords
- intervention study, stepped wedge study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,210 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention period | Experimental | Other: Trained healthcare professionals deliver a simple, standardized and redundant 3-point message to patients, based on the levers of action for therapeutic adherence.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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Patients included in the control period.
- Patients under guardianship.
- Pregnant or breast-feeding patients.
- Patients taking part in research on compliance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trained healthcare professionals deliver a simple, standardized and redundant 3-point message to patients, based on the levers of action for therapeutic adherence.Also: Intervention periodThis 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. | Other | Intervention period |
Primary outcome
Improvement in therapeutic adherence
Time frame: 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.
6 secondary outcomes
Improvement in therapeutic adherence
Time frame: 12 months
Predictive factors of improved adherence factors predictive of therapeutic adherence
Time frame: 6 months
Improvement in therapeutic adherence estimated
Time frame: 12 months
Costs of care according to periods (control vs. intervention)
Time frame: 12 months
Cost of the intervention
Time frame: 12 months
Satisfaction of participating healthcare professionals and reasons for refusal to participate
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brigitte SABATIER, Dr principal investigator
Assistance Publique - Hôpitaux de Paris
10 sites in 1 country: see every site and its status.
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?
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.