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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02671838

Enrollment

132

Registered

2016-02-02

Start date

2017-01-31

Completion date

2019-10-31

Last updated

2020-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

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.

Interventions

BEHAVIORALMusculoskeletal ultrasound program

Using a musculoskeletal ultrasound program to help improve medication adherence

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	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

Other

Measure	Time frame
Change in clinical follow-up defaults (e.g. how often patients do not show up for their clinic appointments)	baseline, 3 months and 6 months
Change in clinical joint assessment outcomes(e.g. disease activity score 28)	baseline, 3 months and 6 months

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026