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

NCT ID: NCT02671838

Last Updated: 2020-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-10-31

Brief Summary

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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

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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.

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Musculoskeletal ultrasound program

Participants will receive the musculoskeletal ultrasound program

Group Type OTHER

Musculoskeletal ultrasound program

Intervention Type BEHAVIORAL

Using a musculoskeletal ultrasound program to help improve medication adherence

Control

Participants will not be receiving the musculoskeletal ultrasound program.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Musculoskeletal ultrasound program

Using a musculoskeletal ultrasound program to help improve medication adherence

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Singapore General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tan

Role: PRINCIPAL_INVESTIGATOR

Singapore General Hospital

Locations

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Singapore, , Singapore

Site Status

Countries

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Singapore

Other Identifiers

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US-01-2016

Identifier Type: -

Identifier Source: org_study_id