- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00968266
Improving Beliefs About Medication in Patients With Rheumatoid Arthritis
Improving Beliefs About Medication in Patients With Rheumatoid Arthritis: Randomized Controlled Study Into the Effect of a Motivational Patient-centered Intervention for Non-adherent Patients Compared to Usual Care Controls
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Disease Modifying Anti Rheumatic Drugs (DMARDs) reduce disease activity and radiological progression and improve long term functional outcome in patients with Rheumatoid Arthritis (RA). However, adherence is a prerequisite for a drug to be effective. A previous study showed that 33% of the RA-patients using DMARDs are non-adherent. Non-adherence can not be attributed to a single cause, but is the result of a complex and individual decision process. An intervention should not only consider practical barriers, such as forgetfulness, but also cognitive and other psychological variables that might impact medication adherence. Therefore, an intervention was developed focusing primarily on the non-adherent patient's individual beliefs and barriers to adherence.
The effectiveness of this intervention will be evaluated in a randomized clinical trial. Primary outcome measure is beliefs about medication assessed with the Beliefs about Medicines Questionnaire (BMQ). Additionally, adherence and adherence-related variables will be measured with questionnaires.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Nijmegen, Netherlands, 6522 JV
- Sint Maartenskliniek
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- RA according to the 1986 ACR criteria for at least 1 year
- Prescription of anti-rheumatic medication (DMARDs)
- Non-adherent patients (Compliance Questionnaire Rheumatology)
Exclusion Criteria:
- Co-morbidity (physical or psychological) that unables patient to participate in the intervention
- Illiteracy
- Inability to communicate in Dutch
- Participation in other studies with significant burden
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group intervention
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) |
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. |
Active Comparator: Control arm: usual care
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Beliefs about medication, which is measured with Beliefs about Medicines Questionnaire (BMQ)
Time Frame: 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)
|
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)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adherence, measured with Compliance Questionnaire Rheumatology (CQR), Medication Adherence Report Scale (MARS) and refill rates
Time Frame: 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)
|
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)
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Self-efficacy, measured with Arthritis Self Efficacy Scale
Time Frame: 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)
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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)
|
Satisfaction with information about medication, measured with Satisfaction with Information about Medicines Scale (SIMS)
Time Frame: 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)
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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)
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Physical functioning, measured with Health Assessment Questionnaire (HAQ), Rheumatoid Arthritis Disease Activity Index (RADAI) and Visual Analogue Scale Pain (VAS Pain)
Time Frame: 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)
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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)
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Psychological functioning, measured with Hospital Anxiety and Depression Scale (HADS) and Illness Cognition Questionnaire (ICQ)
Time Frame: 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)
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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)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Hanneke Zwikker, MSc, Sint Maartenskliniek
- Principal Investigator: Bart van den Bemt, Sint Maartenskliniek
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RR-56-BMQ
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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