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Evaluation of Rheumatoid Arthritis Disease Education Literature (ERADEL)

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Patient education
Sponsored by
Universiti Sains Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Rheumatoid Arthritis focused on measuring Patient education, Rheumatoid arthritis, Knowledge, Attitudes, Practice

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Clifton Central Hospital
  • Liaqat National Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Patient Education Group

Normal Group

Arm Description

Patients will be provided with disease education literature

Patients will not be provided with disease education literature

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 31, 2017
Last Updated
March 23, 2020
Sponsor
Universiti Sains Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT03336684
Brief Title
Evaluation of Rheumatoid Arthritis Disease Education Literature
Acronym
ERADEL
Official Title
Evaluation of Rheumatoid Arthritis Disease Education Literature: The ERADEL Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
December 18, 2017 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Sains Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Patient education, Rheumatoid arthritis, Knowledge, Attitudes, Practice

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
The investigator will be blinded from randomization and recruitment process.
Allocation
Randomized
Enrollment
376 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient Education Group
Arm Type
Experimental
Arm Description
Patients will be provided with disease education literature
Arm Title
Normal Group
Arm Type
No Intervention
Arm Description
Patients will not be provided with disease education literature
Intervention Type
Behavioral
Intervention Name(s)
Patient education
Intervention Description
Rheumatoid arthritis patients will be provided with disease education literature
Primary Outcome Measure Information:
Title
Patient knowledge about rheumatoid arthritis
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Patient satisfaction
Description
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
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehfooz Alam, MBBS
Organizational Affiliation
Liaqat National Hospital Karachi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Baqir S Naqvi, PhD
Organizational Affiliation
Hamdard University
Official's Role
Study Director
Facility Information:
Facility Name
Clifton Central Hospital
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75600
Country
Pakistan
Facility Name
Liaqat National Hospital
City
Karachi
State/Province
Sindh
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of Rheumatoid Arthritis Disease Education Literature

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