Evaluation of Rheumatoid Arthritis Disease Education Literature

Rheumatoid Arthritis Clinical Trial

— ERADEL  

Official title:

Evaluation of Rheumatoid Arthritis Disease Education Literature: The ERADEL Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03336684
• Other study ID #: PACT2
• Status: Completed
• Phase: N/A
• Start date: December 18, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: March 2020
• Source: University of Science Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 376
• Est. completion date: June 30, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Behavioral:
• Patient education
Rheumatoid arthritis patients will be provided with disease education literature

Locations

Country	Name	City	State
Pakistan	Clifton Central Hospital	Karachi	Sindh
Pakistan	Liaqat National Hospital	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
University of Science Malaysia

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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