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

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ClinicalTrials.gov Identifier: NCT02671838
Recruitment Status : Active, not recruiting
First Posted : February 2, 2016
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Singapore General Hospital

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Behavioral: Musculoskeletal ultrasound program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
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
Actual Study Start Date : January 2017
Actual Primary Completion Date : December 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



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

Secondary Outcome Measures :
  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 Outcome Measures:
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671838


Locations
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Singapore
Singapore, Singapore
Sponsors and Collaborators
Singapore General Hospital
Investigators
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Principal Investigator: Tan Singapore General Hospital
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Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT02671838    
Other Study ID Numbers: US-01-2016
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases