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Completed

NCT Number: NCT00968266

Improving Beliefs About Medication in Patients With Rheumatoid Arthritis

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.

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Key information

Conditions

Musculoskeletal Diseases Arthritis Arthritis, Rheumatoid Autoimmune Diseases Behavior Connective Tissue Diseases Health Behavior Immune System Diseases Joint Diseases Medication Adherence Patient Acceptance of Health Care Patient Compliance Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sint Maartenskliniek

Nijmegen, 6522 JV, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient-centered group intervention

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.

Primary outcomes

  1. Beliefs about medication, which is measured with Beliefs about Medicines Questionnaire (BMQ)

    Time frame: 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

  1. Adherence, measured with Compliance Questionnaire Rheumatology (CQR), Medication Adherence Report Scale (MARS) and refill rates

    Time frame: 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)

  2. Self-efficacy, measured with Arthritis Self Efficacy Scale

    Time frame: 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)

  3. Satisfaction with information about medication, measured with Satisfaction with Information about Medicines Scale (SIMS)

    Time frame: 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)

  4. Physical functioning, measured with Health Assessment Questionnaire (HAQ), Rheumatoid Arthritis Disease Activity Index (RADAI) and Visual Analogue Scale Pain (VAS Pain)

    Time frame: 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)

  5. Psychological functioning, measured with Hospital Anxiety and Depression Scale (HADS) and Illness Cognition Questionnaire (ICQ)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Sint Maartenskliniek

Other

Collaborators

  • Radboud University Medical Center

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Aug 28, 2009
Registry last updated
Dec 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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