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

October 25, 2020 updated by: Singapore General Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in proportion of patients with a low adherence score using medication adherence measure (questionnaire)
Time Frame: baseline, 3 months and 6 months
baseline, 3 months and 6 months
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
baseline, 1 month, 3months and 6 months

Other Outcome Measures

Outcome Measure
Time Frame
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
baseline, 3 months and 6 months
Change in clinical joint assessment outcomes(e.g. disease activity score 28)
Time Frame: baseline, 3 months and 6 months
baseline, 3 months and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Singapore General Hospital

Investigators

  • Principal Investigator: Tan, Singapore General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

January 26, 2016

First Submitted That Met QC Criteria

January 29, 2016

First Posted (Estimate)

February 2, 2016

Study Record Updates

Last Update Posted (Actual)

October 27, 2020

Last Update Submitted That Met QC Criteria

October 25, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • US-01-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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