Arthritis, RheumatoidNCT04499001
Effect of Pharmaceutical Consultations Just Before Rheumatology Consultations on Improving Knowledge and Skills for Patients With Inflammatory Arthritis With Subcutaneous Biologic DMARDs
An observational study of Arthritis, Rheumatoid and Spondyloarthritis, run by Hôpital Cochin at 1 site in France.
Trial summary
There is a lack of knowledge among patients concerning their treatment with bDMARDs. To increase knowledge and safety skills, patient education is essential. The aim of this study is to assess the impact of a pharmacist's educational interview on on knowledge and safety skills to bDMARDs in patients with inflammatory… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid, Spondyloarthritis, Biological Therapy
- What is being tested?
- Pharmacist's consultation
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2019to 31 Jul 2020
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients treated with subcutaneous bDMARDs with inflammatory arthritis admitted in medical consultation in the rheumatology department
Who may be able to join
- Patients must be able to understand and communicate in French and comply with the requirements of the study and must give his agreement (non-opposition) before any study assessment is performed.
- Patient at least 18 years of age
- Patient with inflammatory arthritis (rheumatoid arthritis or ankylosing spondylitis or other)
- Admission in medical consultation in the rheumatology department
- Patient treated with subcutaneous biologic DMARDs (Tocilizumab, Adalimumab, Etanercept, Golimumab, Certolizumab, Abatacept, Sarilumab, Ustekinumab, Ixekizumab, Anakinra)
Who cannot join
- Any medical or psychiatric condition which, in the Investigator's opinion, would preclude the participant from completing the study per protocol
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Cochin
Paris
Cécile Bottois, Dr, +33 1 58 41 23 02, cecile.bottois@aphp.fr
Ornella Conort, Dr, +33 1 58 41 23 07, ornella.conort@aphp.fr
About this study
Official title: Effect of Pharmaceutical Consultations Just Before Rheumatology Consultations on Improving Knowledge and Skills for Patients With Inflammatory Arthritis Treated With Subcutaneous Biologic DMARDs
There is a lack of knowledge among patients concerning their treatment with bDMARDs. To increase knowledge and safety skills, patient education is essential.
The aim of this study is to assess the impact of a pharmacist's educational interview on on knowledge and safety skills to bDMARDs in patients with inflammatory arthritis.
Read the detailed description
This is an observational, controlled, open-label and monocentric study. 60 patients are planned to be included.
Knowledge are assessed three time by self-administered questionnaire:
at baseline before the pharmacist's educational interview at three months apart at six months apart
One primary end-point is defined:
the changes from baseline to M3 and M6 in the patients' knowledge score about subcutaneous bDMARD management (self-administered questionnaire, Biosecure)
As secondary end-points, the changes from baseline to M3 and M6 in patients' adherence, patients' satisfaction regarding the pharmacists' intervention and the effect of the interview on rate of patients treated by biosimilar are evaluated.
- Conditions
- Arthritis, Rheumatoid, Spondyloarthritis, Biological Therapy
- Being tested
- Pharmacist's consultation
- Keywords
- knowledge, safety skills, pharmaceutical consultation
- Medical subject headings
- Arthritis, Rheumatoid, Spondylarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist's consultationOther
Information about bDMARDs management.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bDMARDS knowledge and skills at 3 and 6 months in patients who received a pharmaceutical consultation
Knowledge level and score comparison (good or moderate or bad knowledge) evaluated by self-questionnaire (Biosecure) from baseline to M3 and M6 after the pharmaceutical consultation.
Biosecure : Minimum = 0 ; Maximum = 100 Good knowledge > 84 Moderate knoledge : 64 to 84 Bad knowledge < 64
Higher scores mean a better outcome.
Measured: 6 months of follow-up
Secondary outcomes (3)
Change in bDMARDS adherence at 3 and 6 months in patients who received a pharmaceutical consultation
Adherence level comparison (high or low adherence) evaluated by self-questionnaire, Compliance Questionnaire for Rheumatology (CQR-5) from baseline to M3 and M6 after the consultation.
High adherence means a better outcome.
Measured: 6 months of follow-up
Satisfaction of patients on the pharmaceutical interview 3 months apart
Assessment of patients' satisfaction on the pharmaceutical interview at 3 months of the consultation.
Measured: 3 months of follow-up
Change in rate of patients treated by biosimilar after the pharmaceutical consultation
Comparison of patient treated by biosimilar rate from baseline to M3 and M6 after the consultation
Measured: 6 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start1 Oct 2019
- Primary completion31 Jul 2020 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital Cochin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cécile Bottois, Hôpital Cochin
- Investigators
- Cécile Bottois, Dr, Principal investigator, Hôpital Cochin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04499001
- Sponsor's protocol ID
- 2020-A01380-39
- Status last verified
- Jul 2020
- First submitted
- 22 Jul 2020
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pharmaceutical Consultations Just Before Rheumatology Consultations on Improving Knowledge and Skills for Patients With Inflammatory Arthritis Treated With Subcutaneous Biologic DMARDs
- ClinicalTrials.gov ID
- NCT04499001
- Acronym / sponsor ID
- 2020-A01380-39
- Conditions
- Arthritis, Rheumatoid, Spondyloarthritis, Biological Therapy
- Keywords
- knowledge, safety skills, pharmaceutical consultation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hôpital CochinUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 5 Aug 2020 (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.
There is a lack of knowledge among patients concerning their treatment with bDMARDs. To increase knowledge and safety skills, patient education is essential.
The aim of this study is to assess the impact of a pharmacist's educational interview on on knowledge and safety skills to bDMARDs in patients with inflammatory arthritis.
Detailed description
This is an observational, controlled, open-label and monocentric study. 60 patients are planned to be included.
Knowledge are assessed three time by self-administered questionnaire:
at baseline before the pharmacist's educational interview at three months apart at six months apart
One primary end-point is defined:
the changes from baseline to M3 and M6 in the patients' knowledge score about subcutaneous bDMARD management (self-administered questionnaire, Biosecure)
As secondary end-points, the changes from baseline to M3 and M6 in patients' adherence, patients' satisfaction regarding the pharmacists' intervention and the effect of the interview on rate of patients treated by biosimilar are evaluated.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients treated with subcutaneous bDMARDs with inflammatory arthritis admitted in medical consultation in the rheumatology department
Key inclusion criteria (5 listed)
- Patients must be able to understand and communicate in French and comply with the requirements of the study and must give his agreement (non-opposition) before any study assessment is performed.
- Patient at least 18 years of age
- Patient with inflammatory arthritis (rheumatoid arthritis or ankylosing spondylitis or other)
- Admission in medical consultation in the rheumatology department
- Patient treated with subcutaneous biologic DMARDs (Tocilizumab, Adalimumab, Etanercept, Golimumab, Certolizumab, Abatacept, Sarilumab, Ustekinumab, Ixekizumab, Anakinra)
Key exclusion criteria (1 listed)
- Any medical or psychiatric condition which, in the Investigator's opinion, would preclude the participant from completing the study per protocol
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 |
|---|---|---|
| Pharmacist's consultationInformation about bDMARDs management. | Other | – |
Primary outcome
Change in bDMARDS knowledge and skills at 3 and 6 months in patients who received a pharmaceutical consultation
Time frame: 6 months of follow-up
Knowledge level and score comparison (good or moderate or bad knowledge) evaluated by self-questionnaire (Biosecure) from baseline to M3 and M6 after the pharmaceutical consultation. Biosecure : Minimum = 0 ; Maximum = 100 Good knowledge > 84 Moderate knoledge : 64 to 84 Bad knowledge < 64 Higher scores mean a better outcome.
3 secondary outcomes
Change in bDMARDS adherence at 3 and 6 months in patients who received a pharmaceutical consultation
Time frame: 6 months of follow-up
Satisfaction of patients on the pharmaceutical interview 3 months apart
Time frame: 3 months of follow-up
Change in rate of patients treated by biosimilar after the pharmaceutical consultation
Time frame: 6 months of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
- Individual participant dataSharing planned: No
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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.
Cécile Bottois, Dr principal investigator
Hôpital Cochin
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 Arthritis, Rheumatoid and Spondyloarthritis, run by Hôpital Cochin 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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 Aug 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cécile Bottois, Dr (+33 1 58 41 23 02, cecile.bottois@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bDMARDS knowledge and skills at 3 and 6 months in patients who received a pharmaceutical consultation (time frame: 6 months of follow-up). 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 5 Aug 2020.