A Musculoskeletal Ultrasound Program to Improve Disease Modifying Anti-Rheumatic Drugs Adherence in Rheumatoid Arthritis

Not Applicable

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Behavioral: Musculoskeletal ultrasound program

• Registration Number: NCT02671838
• Lead Sponsor: Singapore General Hospital

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.

Study Timeline

• Study First Submitted: 2016-01-26
• Study First Submitted QC: 2016-01-29
• Study First Posted: 2016-02-02
• Study Start: 2017-01
• Primary Completion: 2018-12
• Study Completion: 2019-10
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-25
• Last Update Posted: 2020-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Musculoskeletal ultrasound program	Musculoskeletal ultrasound program	Participants will receive the musculoskeletal ultrasound program

Primary Outcome Measures

Name	Time	Method
Change in proportion of patients with a low adherence score using medication adherence measure (questionnaire)	baseline and 1 month

Secondary Outcome Measures

Name	Time	Method
Change in proportion of patients with a low adherence score using medication adherence measure (questionnaire)	baseline, 3 months and 6 months
Change in proportion of patients with a low adherence score using medication adherence measure (pharmacy dispense data)	baseline, 1 month, 3months and 6 months