NCT00968266 - Improving Beliefs About Medication in Patients With Rheumatoid Arthritis | Crick

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

120

Conditions

Musculoskeletal Diseases Rheumatoid Arthritis

Interventions

Patient-centered group interventionBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Sint Maartenskliniek

Nijmegen, Netherlands