NCT02671838

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 2, 2016

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

October 27, 2020

Status Verified

October 1, 2020

Enrollment Period

1.9 years

First QC Date

January 26, 2016

Last Update Submit

October 25, 2020

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

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

    baseline and 1 month

Secondary Outcomes (2)

  • 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 Outcomes (2)

  • 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

Study Arms (2)

Musculoskeletal ultrasound program

OTHER

Participants will receive the musculoskeletal ultrasound program

Behavioral: Musculoskeletal ultrasound program

Control

NO INTERVENTION

Participants will not be receiving the musculoskeletal ultrasound program.

Interventions

Musculoskeletal ultrasound programBEHAVIORAL

Using a musculoskeletal ultrasound program to help improve medication adherence

Musculoskeletal ultrasound program

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Singapore, Singapore

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Tan

    Singapore General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2016

First Posted

February 2, 2016

Study Start

January 1, 2017

Primary Completion

December 1, 2018

Study Completion

October 1, 2019

Last Updated

October 27, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)