Clinical trial NCT02671838: A Musculoskeletal Ultrasound Program to Improve Disease Modifying Anti-Rheumatic Drugs Adherence in Rheumatoid Arthritis
Official title: Developing a Musculoskeletal Ultrasound Program as an Intervention to Improve Disease Modifying Anti-Rheumatic Drugs Adherence in Rheumatoid Arthritis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2016-02-02
Enrollment: 132
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Non-adherence to medications can lead to sub-optimal treatment in rheumatoid arthritis (RA) patients. In order to improve disease modifying anti-rheumatic drugs (DMARDs) adherence, the investigators are conducting a randomized controlled trial to test out an intervention to improve medications adherence among low adherers. This intervention involves the use of a musculoskeletal ultrasound program which allows RA patients to visualize their joint inflammation and damage real time while treatment adherence is simultaneously reinforced. In doing so, the investigators hope to improve patients' understanding of their joint disease and motivate the participants to adhere to their medications.

Detailed description: This is a single center randomized controlled clinical trial conducted in the Singapore General Hospital. Eligible RA subjects meeting the inclusion and exclusion criteria will be screened using a medication adherence measure questionnaire. Thereafter 132 patients who are low adherers on the questionnaire will then be recruited and randomized (in a 1:1 ratio) to either (a) intervention arm (with musculoskeletal US program) or (b) control arm (without musculoskeletal US program), and followed up over a period of about 6 month.

Eligibility criteria: Inclusion Criteria:

* Male and female patients from 21 to 75 years old
* Underlying rheumatoid arthritis diagnosed using the 1987 or 2010 RA criteria
* On at least one of the following DMARDs (Methotrexate, Sulfasalazine, Hydroxychloroquine and/or Leflunomide)

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Change in proportion of patients with a low adherence score using medication adherence measure (questionnaire)
timeFrame: baseline and 1 month
Secondary outcomes:
measure: Change in proportion of patients with a low adherence score using medication adherence measure (questionnaire)
timeFrame: baseline, 3 months and 6 months
measure: Change in proportion of patients with a low adherence score using medication adherence measure (pharmacy dispense data)
timeFrame: baseline, 1 month, 3months and 6 months
Other outcomes:
measure: Change in clinical follow-up defaults (e.g. how often patients do not show up for their clinic appointments)
timeFrame: baseline, 3 months and 6 months
measure: Change in clinical joint assessment outcomes(e.g. disease activity score 28)
timeFrame: baseline, 3 months and 6 months
Locations:
city: Singapore
country: Singapore
Study officials:
affiliation: Singapore General Hospital
name: Tan
role: PRINCIPAL_INVESTIGATOR
References: