Improving beliefs about medication in patients with Rheumatoid Arthritis: randomised controlled study into the effect of a motivational patient-centered intervention for non-adherent patients compared to usual care controls

Average adherence in patients with a chronic disease is low. People who take
less that 80% of their prescribed medication are defined as non-adherent. To
improve adherence, interventions that target adherence should be aimed at
patients for which adherence is a problem, and the content of the intervention
must be focused to the personal barriers of adherence.

This study focuses on patients with Reumatoid Arthritis (RA). Adherence to
medication in RA is low. Previously research showed that 33% of the patients
with RA do not take their Disease Modifying Anti Rheumatic Drugs (DMARDs) as
prescribed. DMARDs reduce disease activity and radiological progression and
improve long term functional outcome in patients with RA. Non-adherence to
DMARDs can reduce efficacy of treatment. Previous research showed that beliefs
about medication in RA is associated with adherence.

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. Barriers of adherence can vary between patients. Beliefs about
medication seem to play an important role in adherence. Efforts to improve
adherence should only be aimed at non-adherent patients. For the non-adherent
patients the primary cause of non-adherence should be identified, and the
intervention to improve adherence should target the personal barriers(s) of the
patient. If adherence in non-adherent RA-patients improves the efficacy of
DMARD-treatment can be optimized.

Non-adherent patients will be randomly assigned to the experimental and control
condition. The researcher will be blinded for condition allocation. With a
validated questionnaire (Compliance Questionnaire Rheumatology) non-adherent
RA-patients using DMARDs will be selected. Beliefs about medication, adherence
and several psychological and physical outcomes will be assessed using
questionnaires. Also, adherence will be measured using refill rates. The
patient completes four measurements: prior to the intervention and 1 week, 6
months and 12 months after the intervention. In addition, the patient reports
experienced adverse effects and care utilization every month.

The experimental group will receive a motivational patient-centered
intervention aimed at the participant's personal barrier(s). The intervention
includes two group sessions of 90 minutes each and a short follow-up
conversation with the intervention supervisor, the pharmacist, by phone.
Besides giving participant focused education about DMARDs, personal beliefs
about medication will be discussed during the group sessions (6 persons). The
intervention method is based on Motivational Interviewing.
The control group will receive usual care in the Sint Maartenskliniek
(brochures with information about the prescribed DMARDs and rheumatic related
medication). We do not inform the participants explicitely in which condition
they are allocated, because this possibly influence the effect of the
intervention. The participants will be informed about two education programs:
education in writing and group education.

Nature
Patients in the experimental group will be invited to participate in a short
intervention. Patients will attend two group sessions during 90 minutes each.
Two months after the last session the intervention counselor will call the
participants for approximately 10 munites (follow-up call). In the group
session patients will receive written and verbal information about DMARDs
prescription, the working mechanism of DMARDS, and the necessity of DMARDs in
general. Two topics of barriers for adherence will be discussed:
1. Aides and routine habits are discussed and implemented.
2. Personal beliefs about medication will be identified and discussed.

The patients in the control group will receive written information about their
prescribed DMARDs (usual care in the Sint Maartenskliniek).

All patients receive questionnaires prior the intervention, 1 week, 6 months
and 12 months after the intervention.
Also, during the study the patient will report experienced adverse effects and
care utilization every month.

Extent
Time investment for participants in the experimental group: maximal 10 hours
Time investment for participants in the control group: maximal 7 hours

Both the measurements as the intervention program do not constitute a risk for
the participants.