Improving Beliefs About Medication in Patients With Rheumatoid Arthritis

NCT ID: NCT00968266

Last Updated: 2023-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2012-04-30

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.

Conditions

Musculoskeletal Diseases; Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: EXPERIMENTAL

Patient-centered group intervention

Intervention Type: BEHAVIORAL

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.

Control arm: usual care

In the control arm, patients receive a brochure about the DMARDs they are currently using.

Group Type: ACTIVE_COMPARATOR

Patient-centered group intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: collaborator

Sint Maartenskliniek

OTHER

Sponsor Role: lead

Responsible Party

Joke Vriezekolk

Senior researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hanneke Zwikker, MSc

Role: PRINCIPAL_INVESTIGATOR

Sint Maartenskliniek

Bart van den Bemt

Role: PRINCIPAL_INVESTIGATOR

Sint Maartenskliniek

Locations

Sint Maartenskliniek

Nijmegen, , Netherlands

Countries

Netherlands

Other Identifiers

RR-56-BMQ

Identifier Type: -

Identifier Source: org_study_id