Improving Beliefs About Medication in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00968266
• Other study ID #: RR-56-BMQ
• Status: Completed
• Phase: N/A
• Start date: September 2009
• Est. completion date: April 2012

Study information

• Verified date: December 2023
• Source: Sint Maartenskliniek
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Musculoskeletal Diseases
• Rheumatoid Arthritis

Intervention

Behavioral:
• Patient-centered group intervention
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.

Locations

Country	Name	City	State
Netherlands	Sint Maartenskliniek	Nijmegen

Sponsors (2)

Lead Sponsor	Collaborator
Sint Maartenskliniek	Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)