NCT00968266|CompletedDMC
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Sponsor study identifier
interventional
120
1 country
1
Study Start
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2011
Actual (reported)Study Completion
April 2012
Actual (reported)The purpose of this study is to determine if a short motivational patient-centered intervention for non-adherent patients is more successful in improving beliefs about medication (and adherence) compared to a usual care control group of non-adherent patients.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 27, 2009
Actual (reported)August 28, 2009
Actual (reported)September 2009
Date type not reportedThis date has not been verified as actual or estimated.
March 2011
Actual (reported)April 2012
Actual (reported)Beliefs about medication, which is measured with Beliefs about Medicines Questionnaire (BMQ)
3 weeks before first intervention session (T0), 2 weeks after first intervention session (T1), 6 months after first intervention session (T3), 12 months after first intervention session (T4)
Adherence, measured with Compliance Questionnaire Rheumatology (CQR), Medication Adherence Report Scale (MARS) and refill rates
3 weeks before first intervention session (T0), 2 weeks after first intervention session (T1), 6 months after first intervention session (T3), 12 months after first intervention session (T4)
Self-efficacy, measured with Arthritis Self Efficacy Scale
3 weeks before first intervention session (T0), 2 weeks after first intervention session (T1), 6 months after first intervention session (T3), 12 months after first intervention session (T4)
In short, the intervention consists of two group sessions moderated by a pharmacist. During these sessions, patients' self-perceived needs to take medication ('necessity beliefs'), concerns about taking medication ('concern beliefs'), and practical barriers are discussed. To explore a patient's individual ambivalence regarding his/her beliefs and barriers, the pharmacist uses Motivational Interviewing techniques. In between the sessions, participants make a homework assignment about their own beliefs and barriers, and eight weeks after the second session, a follow-up call to the individual patients is made by the pharmacist. Patients in the experimental arm also receive a brochure about the DMARDs they currently use (see: control arm)
In the control arm, patients receive a brochure about the DMARDs they are currently using.
Session 1: Group discussion about the personal barriers for medication adherence. Supervisor: Pharmacist. Duration: 90 minutes. Goal: After this session the patient is aware of the benefits and barriers of adherence. The individual barriers to adherence (concerns and practical problems) and necessity beliefs about medication are identified and discussed. Session 2: Group based education on benefits of medication and discussing personal concerns about medication, practical barriers and beliefs about the necessity of medication. Supervisor: Pharmacist and rheumatologist. Duration: 90 minutes. Goal: Improving realistic beliefs about medication, stimulating an equal relationship between patient and health professional and motivating patients to be adherent.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Sint Maartenskliniek
Nijmegen, 6522 JV, Netherlands
Hanneke Zwikker, MSc
Sint Maartenskliniek
Bart van den Bemt
Sint Maartenskliniek
120 participants (actual enrollment reported by the registry).
First Submitted
August 27, 2009
First Posted
August 28, 2009
Study Start
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
Iyengar Yoga for Young People With Rheumatoid Arthritis
Satisfaction with information about medication, measured with Satisfaction with Information about Medicines Scale (SIMS)
3 weeks before first intervention session (T0), 2 weeks after first intervention session (T1), 6 months after first intervention session (T3), 12 months after first intervention session (T4)
Physical functioning, measured with Health Assessment Questionnaire (HAQ), Rheumatoid Arthritis Disease Activity Index (RADAI) and Visual Analogue Scale Pain (VAS Pain)
3 weeks before first intervention session (T0), 2 weeks after first intervention session (T1), 6 months after first intervention session (T3), 12 months after first intervention session (T4)
Psychological functioning, measured with Hospital Anxiety and Depression Scale (HADS) and Illness Cognition Questionnaire (ICQ)
3 weeks before first intervention session (T0), 2 weeks after first intervention session (T1), 6 months after first intervention session (T3), 12 months after first intervention session (T4)
Contact the study team to confirm eligibility.
Primary Completion
March 2011
Actual (reported)Study Completion
April 2012
Actual (reported)Last Updated
December 15, 2023
Record last verified: 2023-12
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Source: ClinicalTrials.gov.
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