Chronic Inflammatory DiseaseIMPEBIONCT06620770
Impact of the Therapeutic Education Program "living with a Chronic Inflammatory Disease Under Biotherapy" on Patient Compliance and Quality of Life
An observational study of Chronic Inflammatory Disease, run by Groupe Hospitalier de Bretagne Sud at 1 site in France.
Trial summary
Patient therapeutic education programs have been shown to be effective in many specialties, allowing "Improving biological and psychological parameters, allowing patients to improve their health knowledge, therapeutic adherence and sense of personal effectiveness." Several studies have shown that patient knowledge… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Inflammatory Disease
- What is being tested?
- questionnaires
- Type of treatment
- Injection or infusion
- How many people
- 126 participants
- Where
- 1 siteFrance
- Study dates
- 14 Feb 2025to Mar 2028
- Phase
- Observational
- 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
Study population: All major patients followed up on GHBS for chronic inflammatory disease treated with S/C biotherapy.
Who may be able to join
- All major patients followed up on GHBS for chronic inflammatory disease treated with S/C biotherapy.
- Patients not opposed to their participation in the research.
- Less than 3 months between inclusion and start of Therapeutic Education Program.
Who cannot join
- Subcutaneous injection by another person.
- Patients with cognitive impairment.
- Persons of legal age who are the subject of a legal protection (safeguarding of justice, curatorship, guardianship), persons deprived of liberty.
- Pregnant women.
- Persons not covered by social security.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Groupe Hospitalier de Bretagne Sud
Lorient, 56100
Nolwen Leissen, 02 97 06 74 61 ext. +33, n.leissen@ghbs.bzh
Pierre Bouju, 02 97 06 75 14 ext. +33, p.bouju@ghbs.bzh
About this study
Official title: Impact of the Therapeutic Education Program "living with Chronic Inflammatory Disease Under Biotherapy" on Compliance and Quality of Life of Patients
Patient therapeutic education programs have been shown to be effective in many specialties, allowing "Improving biological and psychological parameters, allowing patients to improve their health knowledge, therapeutic adherence and sense of personal effectiveness." Several studies have shown that patient knowledge, adherence and satisfaction are better after attending a therapeutic education program.
This multidisciplinary program is presented and offered to all patients with chronic disease treated by subcutaneous biotherapy, followed by dermatologists, rheumatologists and gastroenterologists of the Lorient hospital.
The study aims to demonstrate the benefit of the Patient Therapeutic Education program at GHBS Lorient "living with a chronic inflammatory disease under biotherapy" on treatment adherence, as well as the positive impact on quality of life.
Read the detailed description
All patients followed up as part of their chronic disease and treated with subcutaneous biotherapy in the dermatology, rheumatology, hepatotherapygastroenterology, will be offered participation in the therapeutic education program by GHBS specialists. Whether they agree to participate or not, doctors will offer them participation in the IMPEBIO study.
Patients treated with subcutaneous biotherapy who do not wish to participate in the program will be included in the control group.
Patients treated with subcutaneous biotherapy who wish to participate in this program will be included in the intervention group. The therapeutic education program will begin within 3 months of inclusion.
If the patient does not object, the Morisky scale and the SF 12 questionnaire will be given to him. It may be assisted with filling if necessary by a clinical researcher.
Patients will first complete the Morisky test, and the quality of life questionnaire SF 12 at inclusion in the IMPEBIO study (J0), then to M6 (6 months), M12 (12 months) and M18 (18 months).
These questionnaires will then be retrieved, anonymized and sent to the investigation department. The analysis of questionnaires will not lead to changes in patient management.
Estimated time to complete the questionnaires is 10 minutes.
- Conditions
- Chronic Inflammatory Disease
- Being tested
- questionnaires
- Keywords
- Biotherapy, Therapeutic education program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesOther
Morisky and SF12 Questionnaires delivery at inclusion, 6, 12 and 18 months
| Study group | Role | What they receive |
|---|---|---|
| Patients participating in the therapeutic education program | Patients treated with subcutaneous biotherapy who wish to participate in the therapeutic education program will be included in the intervention group. This program will begin within 3 months of inclusion.
An initial meeting with a nurse allows for a shared educational assessment. The other days are planned monthly with groups of up to 6 people. A discussion around biotherapies is established by a doctor-nurse pair on theoretical and practical questions. In a second step, questions around nutrition are addressed with the dietician. Mealtime is also a time for discussion with professionals and the group of patients. The third workshop is led by a physical activity teacher. A nurse and a patient partner lead a time dedicated to fatigue management in the form of practical exercises that can be easily reproduced at home. Receives: Other: questionnaires | |
| Patients who do not wish to participate in the therapeutic education program | Patients treated with subcutaneous biotherapy who do not wish to participate in the therapeutic education program will be included in the control group.
Patients will be followed by their physicians as usual. Receives: Other: questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores of the Morisky scale
Comparison of the scores of the Morisky scale in patients with chronic inflammatory disease treated by S/C biotherapy at 18 months after inclusion versus patients who only received nurse consultation.
Measured: 18 months after inclusion
Secondary outcomes (2)
Scores of the Morisky scale
Comparison of scores on the Morisky scale in patients with chronic inflammatory disease treated by S/C biotherapy at 6 and 12 months after inclusion versus patients who only received nurse consultation.
Measured: 6 and 12 months after inclusion
SF-12 quality of life questionnaire
Comparison of the SF-12 quality of life questionnaire in patients at 6, 12 and 18 months after inclusion versus patients who only received nurse consultation.
Measured: 6 and 12 and 18 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start14 Feb 2025
- Primary completionMar 2027 (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 Inflammatory DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier de Bretagne Sud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Gall, Principal investigator, Groupe Hospitalier de Bretagne Sud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06620770
- Sponsor's protocol ID
- 56LORC_2023_IMPEBIO
- Acronym
- IMPEBIO
- Status last verified
- Mar 2025
- First submitted
- 27 Sep 2024
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Therapeutic Education Program "living with Chronic Inflammatory Disease Under Biotherapy" on Compliance and Quality of Life of Patients
- ClinicalTrials.gov ID
- NCT06620770
- Acronym / sponsor ID
- IMPEBIO / 56LORC_2023_IMPEBIO
- Conditions
- Chronic Inflammatory Disease
- Keywords
- Biotherapy, Therapeutic education program
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Groupe Hospitalier de Bretagne SudUniversity, hospital or other
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 1 Oct 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.
Patient therapeutic education programs have been shown to be effective in many specialties, allowing "Improving biological and psychological parameters, allowing patients to improve their health knowledge, therapeutic adherence and sense of personal effectiveness." Several studies have shown that patient knowledge, adherence and satisfaction are better after attending a therapeutic education program.
This multidisciplinary program is presented and offered to all patients with chronic disease treated by subcutaneous biotherapy, followed by dermatologists, rheumatologists and gastroenterologists of the Lorient hospital.
The study aims to demonstrate the benefit of the Patient Therapeutic Education program at GHBS Lorient "living with a chronic inflammatory disease under biotherapy" on treatment adherence, as well as the positive impact on quality of life.
Detailed description
All patients followed up as part of their chronic disease and treated with subcutaneous biotherapy in the dermatology, rheumatology, hepatotherapygastroenterology, will be offered participation in the therapeutic education program by GHBS specialists. Whether they agree to participate or not, doctors will offer them participation in the IMPEBIO study.
Patients treated with subcutaneous biotherapy who do not wish to participate in the program will be included in the control group.
Patients treated with subcutaneous biotherapy who wish to participate in this program will be included in the intervention group. The therapeutic education program will begin within 3 months of inclusion.
If the patient does not object, the Morisky scale and the SF 12 questionnaire will be given to him. It may be assisted with filling if necessary by a clinical researcher.
Patients will first complete the Morisky test, and the quality of life questionnaire SF 12 at inclusion in the IMPEBIO study (J0), then to M6 (6 months), M12 (12 months) and M18 (18 months).
These questionnaires will then be retrieved, anonymized and sent to the investigation department. The analysis of questionnaires will not lead to changes in patient management.
Estimated time to complete the questionnaires is 10 minutes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients participating in the therapeutic education program | – | Other: questionnairesPatients treated with subcutaneous biotherapy who wish to participate in the therapeutic education program will be included in the intervention group. This program will begin within 3 months of inclusion. An initial meeting with a nurse allows for a shared educational assessment. The other days are planned monthly with groups of up to 6 people. A discussion around biotherapies is established by a doctor-nurse pair on theoretical and practical questions. In a second step, questions around nutrition are addressed with the dietician. Mealtime is also a time for discussion with professionals and the group of patients. The third workshop is led by a physical activity teacher. A nurse and a patient partner lead a time dedicated to fatigue management in the form of practical exercises that can be easily reproduced at home. |
| Patients who do not wish to participate in the therapeutic education program | – | Other: questionnairesPatients treated with subcutaneous biotherapy who do not wish to participate in the therapeutic education program will be included in the control group. Patients will be followed by their physicians as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All major patients followed up on GHBS for chronic inflammatory disease treated with S/C biotherapy.
Key inclusion criteria (3 listed)
- All major patients followed up on GHBS for chronic inflammatory disease treated with S/C biotherapy.
- Patients not opposed to their participation in the research.
- Less than 3 months between inclusion and start of Therapeutic Education Program.
Key exclusion criteria (5 listed)
- Subcutaneous injection by another person.
- Patients with cognitive impairment.
- Persons of legal age who are the subject of a legal protection (safeguarding of justice, curatorship, guardianship), persons deprived of liberty.
- Pregnant women.
- Persons not covered by social security.
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 |
|---|---|---|
| questionnairesMorisky and SF12 Questionnaires delivery at inclusion, 6, 12 and 18 months | Other | Patients participating in the therapeutic education program, Patients who do not wish to participate in the therapeutic education program |
Primary outcome
Scores of the Morisky scale
Time frame: 18 months after inclusion
Comparison of the scores of the Morisky scale in patients with chronic inflammatory disease treated by S/C biotherapy at 18 months after inclusion versus patients who only received nurse consultation.
2 secondary outcomes
Scores of the Morisky scale
Time frame: 6 and 12 months after inclusion
SF-12 quality of life questionnaire
Time frame: 6 and 12 and 18 months after inclusion
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 14 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
Olivier Gall principal investigator
Groupe Hospitalier de Bretagne Sud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Inflammatory Disease, run by Groupe Hospitalier de Bretagne Sud at 1 site 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 3 inclusion and 5 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 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Olivier Gall (02 97 06 79 11 ext. +33, o.gall@ghbs.bzh), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scores of the Morisky scale (time frame: 18 months after inclusion). 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 14 Mar 2025.