Rheumatoid ArthritisETP-PRNCT01564147
More Added Value of Therapeutic Education in the Management of Patients With Rheumatoid Arthritis (ETP-PR)
A study testing immediate therapeutic education and therapeutic education delayed in people with Rheumatoid Arthritis, run by Nantes University Hospital at 1 site in France.
Trial summary
Taking into account the recommendations of the Health Authority [1] and the application of patients' associations, we have structured a course of therapeutic education includes three stages for patients with rheumatoid arthritis and followed at Nantes University Hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- immediate therapeutic education and therapeutic education delayed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2011to Feb 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patient presenting at clinics for Rheumatology or the Rheumatology Day Hospital at the University Hospital or hospitalized in the department of Rheumatology
- Men or women
- Having signed the consent
- major
- Affiliated to social security or covered by the CMU
- Patient with rheumatoid arthritis meeting the ACR criteria
- Patient with rheumatoid arthritis stable for at least 6 months (change in DAS 28 <1.2)
Who cannot join
- Patient can not understand the information
- Patient confined to bed or chair, unable to care for himself or not doing with difficulty
- pregnant patient
- minors
- Adults under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: More Added Value of Therapeutic Education in the Management of Patients With Rheumatoid Arthritis
Taking into account the recommendations of the Health Authority [1] and the application of patients' associations, we have structured a course of therapeutic education includes three stages for patients with rheumatoid arthritis and followed at Nantes University Hospital. Step 1: initial interview with a nurse patient education for diagnosis and education with the patient to choose three subjects from among 10 offered him problematic; Step 2: Orientation in an educational path that provides access to 6 months group workshops (3 maximum) and / or interviews tailored to the three selected topics; Step 3: final interview with a nurse said therapeutic education formative assessment to take stock. The main objective of our work is to ensure that the patient finds it easier solutions to the three problematic topics him after 6 months of education after six months without treatment.
- Conditions
- Rheumatoid Arthritis
- Being tested
- immediate therapeutic education, therapeutic education delayed
- Keywords
- Therapeutic Education, Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate therapeutic educationOther
Access to the course of immediate therapeutic education
therapeutic education delayedOther
Group receiving therapeutic education 6 months later (control group)
| Study group | Role | What they receive |
|---|---|---|
| Immediate Education therapeutic | Other | Access to the course of immediate therapeutic education Receives: Other: immediate therapeutic education |
| therapeutic education delayed | Other | Group receiving therapeutic education 6 months later (control group) Receives: Other: therapeutic education delayed |
What is being measured
The primary outcome is the main question the study is designed to answer.
EVA measures the overall ability to find solutions applicable to their situation
Investigate whether, overall, the patient is more easily applicable solutions to the situation after six months of therapeutic education after six months without therapeutic education for three problems identified after the initial filling of the questionnaire (controls ) and after the initial interview with the nurse (test group)
Measured: 12 months
Secondary outcomes (14)
EVA measures the ability to find solutions applicable to their situation for each of the three problems identified.
Ability to find solutions applicable to their situation for each of the three problems identified
Measured: 12 months
Knowledge (score / 10) treatments for rheumatoid arthritis, knowledge (note/10) signs of a flare of rheumatoid arthritis.
Skills that we consider indispensable
Measured: 12 months
Self-efficacy against a disease flare (EVA), self-efficacy against a side effect of treatment (EVA)
Perceived self-efficacy compared to rheumatoid arthritis
Measured: 12 months
RAPID score 4 (scale)
Scalability of rheumatoid arthritis
Measured: 12 months
EVA measuring fatigue
Fatigue
Measured: 12 months
Duration of morning stiffness in minutes or hours.
Duration of stiffness
Measured: 12 months
CRP and VS
Biological criteria
Measured: 12 months
Scale of STAI S Scale of STAI S
Anxiety
Measured: 12 months
Beck Scale
Depression
Measured: 12 months
Evaluation Test of adherence of Girerd
Observance
Measured: 12 months
Dosage Cortancyl or Solupred.
Use of steroids
Measured: 12 months
Number of visits to physician, rheumatologist at at therapist, psychiatrist, occupational physician, number of hospitalizations, number of meetings with occupational therapist, social worker, dietician, physiotherapist, psychologist...
Consumption of medical and paramedical
Measured: 12 months
Patient satisfaction with respect to information received, the caller and the improvement in different areas of health (EVA)
Satisfaction with patient education
Measured: 12 months
Attendance at meetings / workshops offered after the initial diagnosis.
Membership
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 Mar 2012 (estimated)
- Study startSep 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves Maugars, PU-PH, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01564147
- Sponsor's protocol ID
- BRD/11/02-J
- Acronym
- ETP-PR
- Status last verified
- Aug 2016
- First submitted
- 21 Mar 2012
- Last updated
- 8 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- More Added Value of Therapeutic Education in the Management of Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01564147
- Acronym / sponsor ID
- ETP-PR / BRD/11/02-J
- Conditions
- Rheumatoid Arthritis
- Keywords
- Therapeutic Education, Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 27 Mar 2012 (estimated)
- 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.
Taking into account the recommendations of the Health Authority [1] and the application of patients' associations, we have structured a course of therapeutic education includes three stages for patients with rheumatoid arthritis and followed at Nantes University Hospital. Step 1: initial interview with a nurse patient education for diagnosis and education with the patient to choose three subjects from among 10 offered him problematic; Step 2: Orientation in an educational path that provides access to 6 months group workshops (3 maximum) and / or interviews tailored to the three selected topics; Step 3: final interview with a nurse said therapeutic education formative assessment to take stock. The main objective of our work is to ensure that the patient finds it easier solutions to the three problematic topics him after 6 months of education after six months without treatment.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Education therapeutic | Other | Other: immediate therapeutic educationAccess to the course of immediate therapeutic education |
| therapeutic education delayed | Other | Other: therapeutic education delayedGroup receiving therapeutic education 6 months later (control group) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient presenting at clinics for Rheumatology or the Rheumatology Day Hospital at the University Hospital or hospitalized in the department of Rheumatology
- Men or women
- Having signed the consent
- major
- Affiliated to social security or covered by the CMU
Key exclusion criteria (5 listed)
- Patient can not understand the information
- Patient confined to bed or chair, unable to care for himself or not doing with difficulty
- pregnant patient
- minors
- Adults under guardianship
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 |
|---|---|---|
| immediate therapeutic educationAccess to the course of immediate therapeutic education | Other | Immediate Education therapeutic |
| therapeutic education delayedGroup receiving therapeutic education 6 months later (control group) | Other | therapeutic education delayed |
Primary outcome
EVA measures the overall ability to find solutions applicable to their situation
Time frame: 12 months
Investigate whether, overall, the patient is more easily applicable solutions to the situation after six months of therapeutic education after six months without therapeutic education for three problems identified after the initial filling of the questionnaire (controls ) and after the initial interview with the nurse (test group)
14 secondary outcomes
EVA measures the ability to find solutions applicable to their situation for each of the three problems identified.
Time frame: 12 months
Knowledge (score / 10) treatments for rheumatoid arthritis, knowledge (note/10) signs of a flare of rheumatoid arthritis.
Time frame: 12 months
Self-efficacy against a disease flare (EVA), self-efficacy against a side effect of treatment (EVA)
Time frame: 12 months
RAPID score 4 (scale)
Time frame: 12 months
EVA measuring fatigue
Time frame: 12 months
Duration of morning stiffness in minutes or hours.
Time frame: 12 months
CRP and VS
Time frame: 12 months
Scale of STAI S Scale of STAI S
Time frame: 12 months
Beck Scale
Time frame: 12 months
Evaluation Test of adherence of Girerd
Time frame: 12 months
Dosage Cortancyl or Solupred.
Time frame: 12 months
Number of visits to physician, rheumatologist at at therapist, psychiatrist, occupational physician, number of hospitalizations, number of meetings with occupational therapist, social worker, dietician, physiotherapist, psychologist...
Time frame: 12 months
Patient satisfaction with respect to information received, the caller and the improvement in different areas of health (EVA)
Time frame: 12 months
Attendance at meetings / workshops offered after the initial diagnosis.
Time frame: 12 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2016.
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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. This study is not recruiting at the moment.
Yves Maugars, PU-PH principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immediate therapeutic education and therapeutic education delayed in people with Rheumatoid Arthritis, run by Nantes University Hospital 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 7 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: stopped early, as of the sponsor's last update on 8 Aug 2016. 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?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EVA measures the overall ability to find solutions applicable to their situation (time frame: 12 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 8 Aug 2016.