SpondyloarthritisSPADHESIONNCT04001673
Pharmaceutical Intervention and Adherence to bDMARDs in Spondyloarthritis.
A study testing Pharmacist's intervention in people with Spondyloarthritis and Treatment Adherence, run by Dr Ornella Conort at 1 site in France.
Trial summary
There is a lack of knowledge among patients concerning their treatment with bDMARDs, which could lead to low adherence. The objective of this study is to assess the impact of a pharmacist's intervention on the adherence to bDMARDs in patients with Spondyloarthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondyloarthritis, Treatment Adherence
- What is being tested?
- Pharmacist's intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 15 Feb 2017to 15 Sep 2018
- 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
- Outpatients from Rheumatology Department at Cochin Hospital
- Diagnosis of Spondyloarthritis
- Under treatment with subcutaneous bDMARDs for at least 6 months
- Disease activity stable for at least 6 months
- No treatment modification 3 months before or after inclusion in the study
- Informed consent signed and dated
- Older than 18 years
- Patients who speak french
Who cannot join
- Patients who have had a change in the treatment of SpA during the 3 months prior or after the inclusion
- History of psychological problems
- Patients who need other persons to manage their treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Pharmacist's Intervention on Knowledge and Adherence to Biologic Disease-modifying Drugs in Patients With Spondyloarthritis: a Randomised Controlled Trial.
There is a lack of knowledge among patients concerning their treatment with bDMARDs, which could lead to low adherence.
The objective of this study is to assess the impact of a pharmacist's intervention on the adherence to bDMARDs in patients with Spondyloarthritis.
Read the detailed description
This is an interventional, controlled, open-label and monocentric study. 80 patients are planned to be included.
After written informed consent will be obtained, the patients will be randomized in two arms:
- Intervention arm: intervention of a pharmacist who will explain bDMARDs management.
- Control arm, without intervention.
Two primary end-points are defined:
- the changes from baseline to M6 in the patients' knowledge score about subcutaneous bDMARD management
- the changes from baseline to M6 in Medication Possession Ratio (MPR)
As secondary end-points, the changes in disease activity and patients' satisfaction regarding the pharmacists' intervention are evaluated.
- Conditions
- Spondyloarthritis, Treatment Adherence
- Being tested
- Pharmacist's intervention
- Keywords
- treatment knowledge
- Medical subject headings
- Spondylarthritis, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist's interventionBehavioural
Information about bDMARDs management.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacist's intervention | Active comparator | Evaluation of knowledge and adherence of patients treated by bDMARDs before and after the intervention of a pharmacist that will give information concerning bDMARDs management. Receives: Behavioral: Pharmacist's intervention |
| Control | No intervention | Evaluation of knowledge and adherence of patients treated by bDMARDs who did not receive pharmacist's intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in bDMARDS adherence at 6 months in patients who received a pharmaceutical intervention.
MPR score comparison between the two arms after 6 month of follow up. MPR represents the number of subcutaneous bDMARDs supplied by a pharmacy divided by the number of theorical subcutaneous bDMARDs that the patient should have taken within the observation period (e.g. during the 4 months preceeding the baseline or the M6 visit), expressed in percentage.
Measured: 6 months of follow-up
Improvement in knowledge about bDMARDs management.
Knowledge level comparison (well-known, not known, partially known) evaluated by self-questionnaire between the two arms after 6 months of follow-up.
Measured: 6 months of follow-up
Secondary outcomes (2)
Changes in disease activity
BASDAI score comparison between the two arms after 6 month of follow up.
Measured: 6 months of follow-up
Satisfaction of patients after receiving pharmacist's intervention
Answer comparison to the 4-Likert self-questionnaire between the two arms after 6 months of follow-up. The Likert Scale is a four point scale, from not at all satisfied to completely satisfied.
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 posted28 Jun 2019
- Study start15 Feb 2017
- Primary completion15 Sep 2018
- Study completion15 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondyloarthritisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Ornella Conort
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Ornella Conort, Hôpital Cochin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04001673
- Sponsor's protocol ID
- 2016-A01897-44
- Acronym
- SPADHESION
- Status last verified
- Jan 2020
- First submitted
- 26 Jun 2019
- Last updated
- 29 Jan 2020
- Results posted
- 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 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Pharmacist's Intervention on Knowledge and Adherence to Biologic Disease-modifying Drugs in Patients With Spondyloarthritis: a Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT04001673
- Acronym / sponsor ID
- SPADHESION / 2016-A01897-44
- Conditions
- Spondyloarthritis, Treatment Adherence
- Keywords
- treatment knowledge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Dr Ornella ConortUniversity, hospital or other
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 15 Sep 2018 (actual)
- Study completion
- 15 Sep 2018 (actual)
- First posted
- 28 Jun 2019 (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, which could lead to low adherence.
The objective of this study is to assess the impact of a pharmacist's intervention on the adherence to bDMARDs in patients with Spondyloarthritis.
Detailed description
This is an interventional, controlled, open-label and monocentric study. 80 patients are planned to be included.
After written informed consent will be obtained, the patients will be randomized in two arms:
- Intervention arm: intervention of a pharmacist who will explain bDMARDs management.
- Control arm, without intervention.
Two primary end-points are defined:
- the changes from baseline to M6 in the patients' knowledge score about subcutaneous bDMARD management
- the changes from baseline to M6 in Medication Possession Ratio (MPR)
As secondary end-points, the changes in disease activity and patients' satisfaction regarding the pharmacists' intervention are evaluated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacist's intervention | Active comparator | Behavioral: Pharmacist's interventionEvaluation of knowledge and adherence of patients treated by bDMARDs before and after the intervention of a pharmacist that will give information concerning bDMARDs management. |
| Control | No intervention | –Evaluation of knowledge and adherence of patients treated by bDMARDs who did not receive pharmacist's intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Outpatients from Rheumatology Department at Cochin Hospital
- Diagnosis of Spondyloarthritis
- Under treatment with subcutaneous bDMARDs for at least 6 months
- Disease activity stable for at least 6 months
- No treatment modification 3 months before or after inclusion in the study
Key exclusion criteria (3 listed)
- Patients who have had a change in the treatment of SpA during the 3 months prior or after the inclusion
- History of psychological problems
- Patients who need other persons to manage their treatment.
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 interventionInformation about bDMARDs management. | Behavioural | Pharmacist's intervention |
Primary outcome
Improvement in bDMARDS adherence at 6 months in patients who received a pharmaceutical intervention.
Time frame: 6 months of follow-up
MPR score comparison between the two arms after 6 month of follow up. MPR represents the number of subcutaneous bDMARDs supplied by a pharmacy divided by the number of theorical subcutaneous bDMARDs that the patient should have taken within the observation period (e.g. during the 4 months preceeding the baseline or the M6 visit), expressed in percentage.
Improvement in knowledge about bDMARDs management.
Time frame: 6 months of follow-up
Knowledge level comparison (well-known, not known, partially known) evaluated by self-questionnaire between the two arms after 6 months of follow-up.
2 secondary outcomes
Changes in disease activity
Time frame: 6 months of follow-up
Satisfaction of patients after receiving pharmacist's intervention
Time frame: 6 months of follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist's intervention in people with Spondyloarthritis and Treatment Adherence, run by Dr Ornella Conort 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 8 inclusion and 3 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: finished, as of the sponsor's last update on 29 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improvement in bDMARDS adherence at 6 months in patients who received a pharmaceutical intervention. (time frame: 6 months of follow-up). The study lists 2 primary outcomes in all. 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 29 Jan 2020; AzTrials last refreshed its copy on 7 Nov 2026.