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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Developing a Musculoskeletal Ultrasound Program as an Intervention to Improve Disease Modifying Anti-Rheumatic Drugs Adherence in Rheumatoid Arthritis: A Randomized Controlled Trial

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Behavioral: Musculoskeletal ultrasound program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Musculoskeletal ultrasound program<br>Participants will receive the musculoskeletal ultrasound program | Behavioral: Musculoskeletal ultrasound program<br>* Using a musculoskeletal ultrasound program to help improve medication adherence<br>|
| No Intervention: Control<br>Participants will not be receiving the musculoskeletal ultrasound program. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in proportion of patients with a low adherence score using medication adherence measure (questionnaire) |  | baseline and 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |