|- candidate number||20819|
|- NTR Number||NTR4866|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||28-okt-2014|
|- Secondary IDs||2014-1206 CMO Regio Arnhem Nijmegen|
|- Public Title||What is my disease activity? (Dutch: Wat is mijn ziekteactiviteit?)|
|- Scientific Title||Tight control in Rheumatoid Arthritis: A patient-centred strategy to improve adherence in daily clinical practice|
|- hypothesis||Our hypothesis is that our patient centred strategy will empower
patients, will improve patient knowledge on tight control, and will improve patient beliefs about
medicines. We hypothesize that these three improvements will increase the application of tight control in daily clinical
|- Healt Condition(s) or Problem(s) studied||Rheumatoid arthritis|
|- Inclusion criteria||In order to be eligible to participate in this study, a patient must meet all of the following criteria:|
- has RA according to the 1987 ACR criteria for RA
- is treated for RA in the hospital where the study is performed,
- is able to read or understand the Dutch language.
|- Exclusion criteria||A patient will be excluded from participation in this study if her or she is in remission. Remission is defined as a DAS28 score < 2.6 for at least two times in a row.|
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||29-okt-2014|
|- planned closingdate||29-jan-2016|
|- Target number of participants||200|
|- Interventions||The strategy consists of decision supportive information, a ‘DAS-passport’ and support by a specialized rheumatology nurse.
Decision supportive information for patients
An important first step is to educate the patients about tight control. In a leaflet, the DAS28 and the importance of tight control are explained. Patients are encouraged to ask for their disease activity and discuss their medication options with their rheumatologist.
The DAS-passport is a small booklet (like a diary) where patients can write down their own DAS28 score in a table and a graph to see changes in their disease activity over time, information on their RA medication (adaptations) and on the topics they want to discuss with their professional during the next consultation.
Guidance by a specialized nurse
The specialized rheumatology nurse will discuss the decision supportive information and the DAS-passport with the patient. The nurse will stimulate patients to ask questions and express their concerns or problems during the consultation with their rheumatologist.
|- Primary outcome||The primary outcome of this study is patient empowerment measured with the Effective Consumer Scale (EC-17).|
|- Secondary outcome||The secondary outcomes of this study are:|
- Knowledge about tight control, measured by a questionnaire
- Attitude towards medication, measured by the Beliefs about Medicines Questionnaire (BMQ)
- Tight control adherence and DAS28 decrease (data from medical files)
Furthermore, possible confounding factors like age, gender, disease duration, prognostic factors (rheumatoid factor, erosions), previous RA medication and their highest level of education are measured.
A process evaluation will be performed at the end of the study period.
|- Timepoints||Baseline, 6 and 12 months|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||MSc. M. Jonge, de|
|- CONTACT for SCIENTIFIC QUERIES||MSc. M. Jonge, de|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen|
(Source(s) of Monetary or Material Support)
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||28-okt-2014 - 25-nov-2014|