Evaluation of Rheumatoid Arthritis Disease Education Literature (ERADEL)

Evaluation of Rheumatoid Arthritis Disease Education Literature: The ERADEL Trial

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 Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Behavioral: Patient education

• Study Type: Interventional
• Enrollment (Actual): 376
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75600
      • Clifton Central Hospital
    • Karachi, Sindh, Pakistan
      • Liaqat National Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient Education Group; Patients will be provided with disease education literature	Behavioral: Patient education; Rheumatoid arthritis patients will be provided with disease education literature
No Intervention: Normal Group; Patients will not be provided with disease education literature

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient knowledge about rheumatoid arthritis	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	Patient satisfaction with be documented after the educational intervention using a patient satisfaction feedback form. It contains 10 questions related to general satisfaction from the intervention	3 months

Collaborators and Investigators

• Sponsor: Universiti Sains Malaysia
• Investigators: Principal Investigator: Mehfooz Alam, MBBS, Liaqat National Hospital Karachi; Study Director: Baqir S Naqvi, PhD, Hamdard University

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2017
• Primary Completion (Actual): May 31, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: October 31, 2017
• First Submitted That Met QC Criteria: November 7, 2017
• First Posted (Actual): November 8, 2017

Study Record Updates

• Last Update Posted (Actual): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Patient education; Rheumatoid arthritis; Knowledge; Attitudes; Practice
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: PACT2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No