Improving Beliefs About Medication in Patients With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Collaborator:
Radboud University
Information provided by (Responsible Party):
Hanneke Zwikker, Sint Maartenskliniek
ClinicalTrials.gov Identifier:
NCT00968266
First received: August 27, 2009
Last updated: May 7, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Musculoskeletal Diseases
Rheumatoid Arthritis
Behavioral: Patient-centered group intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Sint Maartenskliniek:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: September 2009
Study Completion Date: April 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group intervention
The experimental group will receive a group intervention of two sessions targeting the participants individual adherence barrier(s) and a short follow-up call. This intervention is patient-centered and focuses on the patient's barriers to adherence: concerns about medication and practical barriers. Also, the patient's necessity beliefs about the use of medication will be discussed.
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.

No Intervention: usual care

If new DMARDs are prescribed, the patient receives a brochure about this medication with information about the medication and the way of taking it correctly (usual care).

Control group: To be sure that everybody indeed has received brochures about the prescribed medication and about the correct way of taking it, the patients will receive the brochure(s) once again at home.

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.


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00968266

Locations
Netherlands
Sint Maartenskliniek
Nijmegen, Netherlands, 6522 JV
Sponsors and Collaborators
Sint Maartenskliniek
Radboud University
Investigators
Principal Investigator: Hanneke Zwikker, MSc Sint Maartenskliniek
Principal Investigator: Bart van den Bemt Sint Maartenskliniek
  More Information

No publications provided

Responsible Party: Hanneke Zwikker, MSc., Sint Maartenskliniek
ClinicalTrials.gov Identifier: NCT00968266     History of Changes
Other Study ID Numbers: RR-56-BMQ
Study First Received: August 27, 2009
Last Updated: May 7, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Sint Maartenskliniek:
Adherence
Compliance
Rheumatoid Arthritis
Intervention
Beliefs about medication
Motivational Interviewing
Medication adherence
Patient compliance
Intervention studies

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Musculoskeletal Diseases
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 29, 2014