Back to resultsA Musculoskeletal Ultrasound Program to Improve Disease Modifying Anti-Rheumatic Drugs Adherence in Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Musculoskeletal ultrasound program
Sponsored by
About this trial
This is an interventional health services research trial for Rheumatoid Arthritis
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
Musculoskeletal ultrasound program
Control
Arm Description
Participants will receive the musculoskeletal ultrasound program
Participants will not be receiving the musculoskeletal ultrasound program.
Outcomes
Primary Outcome Measures
Change in proportion of patients with a low adherence score using medication adherence measure (questionnaire)
Secondary Outcome Measures
Change in proportion of patients with a low adherence score using medication adherence measure (questionnaire)
Change in proportion of patients with a low adherence score using medication adherence measure (pharmacy dispense data)
Full Information
NCT ID
NCT02671838
First Posted
January 26, 2016
Last Updated
October 25, 2020
Sponsor
Singapore General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02671838
Brief Title
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
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
October 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
132 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Musculoskeletal ultrasound program
Arm Type
Other
Arm Description
Participants will receive the musculoskeletal ultrasound program
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants will not be receiving the musculoskeletal ultrasound program.
Intervention Type
Behavioral
Intervention Name(s)
Musculoskeletal ultrasound program
Intervention Description
Using a musculoskeletal ultrasound program to help improve medication adherence
Primary Outcome Measure Information:
Title
Change in proportion of patients with a low adherence score using medication adherence measure (questionnaire)
Time Frame
baseline and 1 month
Secondary Outcome Measure Information:
Title
Change in proportion of patients with a low adherence score using medication adherence measure (questionnaire)
Time Frame
baseline, 3 months and 6 months
Title
Change in proportion of patients with a low adherence score using medication adherence measure (pharmacy dispense data)
Time Frame
baseline, 1 month, 3months and 6 months
Other Pre-specified Outcome Measures:
Title
Change in clinical follow-up defaults (e.g. how often patients do not show up for their clinic appointments)
Time Frame
baseline, 3 months and 6 months
Title
Change in clinical joint assessment outcomes(e.g. disease activity score 28)
Time Frame
baseline, 3 months and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tan
Organizational Affiliation
Singapore General Hospital
Official's Role
Principal Investigator
Facility Information:
City
Singapore
Country
Singapore
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Musculoskeletal Ultrasound Program to Improve Disease Modifying Anti-Rheumatic Drugs Adherence in Rheumatoid Arthritis
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