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Het effect van electronisch gegenereerde feedback over reumageneesmiddelen bij patiënten met reumatoïde artritis


- candidate number18270
- NTR NumberNTR4667
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-jul-2014
- Secondary IDs2014/137 METC
- Public TitleHet effect van electronisch gegenereerde feedback over reumageneesmiddelen bij patiënten met reumatoïde artritis
- Scientific TitleEffectiveness of electronic drug monitoring feedback in order to decrease medication non-adherence, (biological)medication costs and time with high disease activity in RA-patients treated with DMARDs
- ACRONYM
- hypothesisIncreasing medication adherence in rheumatoid arthritis (RA) might reduce disease activity and the need to prescribe more expensive (biological) anti-rheumatic drugs. The usage of drug monitoring devices (like Medication Event Monitoring System (MEMS™)) combined with personal feedback regarding medication behavior has proven in other diseases like HIV to be an effective strategy to improve adherence and therefore clinical outcome, decrease drug changes and drug use.Although these studies suggest that electronic drug monitor feedback might have the potential to prevent unnecessary treatment escalation in rheumatoid arthritis patients with poor adherence, empirical evidence to prove this drug-/cost saving potential is lacking. Therefore, we aim to determine if the implementation of electronic drug monitoring adherence feedback in standard care for patients with rheumatoid arthritis starting with conventional anti-rheumatic drugs is effective on medication adherence compared to a usual care group.
- Healt Condition(s) or Problem(s) studied
- Inclusion criteria• newly diagnosed with RA (2010 ARA criteria or clinical judgement rheumatologist)
• initiating DMARDS
• >18 years
• sufficient ability to understand Dutch
• be able to be followed for 12 months (life expectancy)
- Exclusion criteria• large cognitive limitations
• assistance in taking drugs (e.g. home care)
• included in another randomised controlled trial
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2014
- planned closingdate1-jul-2016
- Target number of participants168
- InterventionsPatients in the intervention group receive their medication during 1 year in an electronic device. Before each regular (3-monthly) consult to the rheumatologist, patient's medication adherence will be assessed by reading out the electronic device and (if necessary) possible barriers to medication intake will be discussed with the pharmacist on a semi-structured way. Patients in the control group will receive standard care (an interview with the pharmacy consultant without electronic drug monitor feedback).
- Primary outcomeThe difference in proportion of non-adherence patients (less than 80% medication adherence) after 1 year
- Secondary outcomeTime to low disease activity, time to the first anti-TNF, the proportion of patients on anti-TNF therapy and disease activity after 1 year
- TimepointsPrimary and secondary outcomes: T=0 en T=12 months
Sec outcomes: T=0, T=2 months, T=6 months, T=6 months, T=12 months
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES A. Houterman
- CONTACT for SCIENTIFIC QUERIESDr. B. Bemt, van den
- Sponsor/Initiator Sint Maartenskliniek Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Reumafonds
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD3-jul-2014 - 1-aug-2014


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