Improving Beliefs About Medication in Patients With Rheumatoid Arthritis

S

Sint Maartenskliniek

Status

Completed

Conditions

Musculoskeletal Diseases
Rheumatoid Arthritis

Treatments

Behavioral: Patient-centered group intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT00968266
RR-56-BMQ

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

120 participants in 2 patient groups

Group intervention
Experimental group
Description:
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)
Treatment:
Behavioral: Patient-centered group intervention
Control arm: usual care
Active Comparator group
Description:
In the control arm, patients receive a brochure about the DMARDs they are currently using.
Treatment:
Behavioral: Patient-centered group intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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