Clinical trial NCT00968266: Improving Beliefs About Medication in Patients With Rheumatoid Arthritis
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Diseases
Rheumatoid Arthritis
Keywords: Adherence
Compliance
Rheumatoid Arthritis
Intervention
Beliefs about medication
Motivational Interviewing
Medication adherence
Patient compliance
Intervention studies
Lead sponsor: Sint Maartenskliniek
Sponsor class: OTHER
Collaborators: name: Radboud University Medical Center
First posted: 2009-08-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Beliefs about medication, which is measured with Beliefs about Medicines Questionnaire (BMQ)
timeFrame: 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 outcomes:
measure: Adherence, measured with Compliance Questionnaire Rheumatology (CQR), Medication Adherence Report Scale (MARS) and refill rates
timeFrame: 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)
measure: Self-efficacy, measured with Arthritis Self Efficacy Scale
timeFrame: 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)
measure: Satisfaction with information about medication, measured with Satisfaction with Information about Medicines Scale (SIMS)
timeFrame: 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)
measure: Physical functioning, measured with Health Assessment Questionnaire (HAQ), Rheumatoid Arthritis Disease Activity Index (RADAI) and Visual Analogue Scale Pain (VAS Pain)
timeFrame: 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)
measure: Psychological functioning, measured with Hospital Anxiety and Depression Scale (HADS) and Illness Cognition Questionnaire (ICQ)
timeFrame: 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)
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Sint Maartenskliniek
Study officials:
affiliation: Sint Maartenskliniek
name: Hanneke Zwikker, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Sint Maartenskliniek
name: Bart van den Bemt
role: PRINCIPAL_INVESTIGATOR
References: