Improving Beliefs About Medication in Patients With Rheumatoid Arthritis

Not Applicable

Completed

• Conditions: Rheumatoid Arthritis; Musculoskeletal Diseases
• Interventions: Behavioral: Patient-centered group intervention

• Registration Number: NCT00968266
• Lead Sponsor: Sint Maartenskliniek

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.

Study Timeline

• Study First Submitted: 2009-08-27
• Study First Submitted QC: 2009-08-27
• Study First Posted: 2009-08-28
• Study Start: 2009-09
• Primary Completion: 2011-03
• Study Completion: 2012-04
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-08
• Last Update Posted: 2023-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control arm: usual care	Patient-centered group intervention	In the control arm, patients receive a brochure about the DMARDs they are currently using.
Group intervention	Patient-centered 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)

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
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)
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)
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)
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)

Trial Locations

Locations (1)

Sint Maartenskliniek; 🇳🇱 Nijmegen, Netherlands