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NCT Number: NCT02671838

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Singapore

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Musculoskeletal ultrasound program

Behavioral

Using a musculoskeletal ultrasound program to help improve medication adherence

Primary outcomes

  1. Change in proportion of patients with a low adherence score using medication adherence measure (questionnaire)

    Time frame: baseline and 1 month

Secondary outcomes

  1. Change in proportion of patients with a low adherence score using medication adherence measure (questionnaire)

    Time frame: baseline, 3 months and 6 months

  2. 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 outcomes

  1. 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

  2. Change in clinical joint assessment outcomes(e.g. disease activity score 28)

    Time frame: baseline, 3 months and 6 months

Sponsors and collaborators

Lead sponsor

Singapore General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Feb 2, 2016
Registry last updated
Oct 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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