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Clinical Trials/NCT03336684
NCT03336684CompletedNot Applicable

Evaluation of Rheumatoid Arthritis Disease Education Literature: The ERADEL Trial

Universiti Sains Malaysia2 sites in 1 country376 target enrollmentStarted: December 18, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
376
Locations
2
Primary Endpoint
Patient knowledge about rheumatoid arthritis

Study Overview

Brief Summary

Rheumatoid arthritis is an inflammatory disease that results in joint inflammation, pain and swelling. It may progress to advance stages that render patients unable to carry out their daily activities. It also results in joints deformity and is a leading cause of disability globally.

Patient education plays an important role in the management of disease. Adequate patient knowledge and awareness about disease may help in incorporating the ailment in daily life. The purpose of this study is to evaluate the benefit of a disease education literature in Urdu language and with culturally relevant illustration for rheumatoid arthritis patients.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Investigator)

Masking Description

The investigator will be blinded from randomization and recruitment process.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Out-patients with established diagnosis of rheumatoid arthritis over 3 months.
  • •Participants who are willing to participate in the study.

Exclusion Criteria

  • •Patients with no rheumatoid arthritis.
  • •Patients currently undergoing surgery or had previous history of surgery.
  • •Patients who are not willing to participate.
  • •In-patients.

Arms & Interventions

Patient Education Group

Experimental

Patients will be provided with disease education literature

Intervention: Patient education (Behavioral)

Normal Group

No Intervention

Patients will not be provided with disease education literature

Outcomes

Primary Outcomes

Patient knowledge about rheumatoid arthritis

Time Frame: 3 months

Measurement of patient's knowledge and awareness about rheumatoid arthritis using The 13-item Rheumatoid Arthritis Knowledge Assessment Scale (RAKAS-13) before and after the intervention. The RAKAS-13 is a psychometric tool consisting of 13 multiple choice questions related to rheumatoid arthritis disease knowledge. All questions have 1 point for "Right" answer and zero (0) points for "Wrong" answer. The scoring criteria are as follows: Excellent knowledge More than 75% correct answers = Above 11 points Adequate knowledge More than 50% or equal to 75% correct answers = 8 - 10 points Low knowledge More than 30% or equal to 50% correct answers = 5 - 7 points Poor knowledge Less than 30% correct answers = 4 points or less.

Secondary Outcomes

  • Patient satisfaction(3 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Atta Abbas Naqvi

Research Assistant

Universiti Sains Malaysia

Study Sites (2)

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