ClinicalTrials.gg
CompletedNCT03336684ERADELUpdated Mar 24, 2020

Evaluation of Rheumatoid Arthritis Disease Education Literature

An interventional study of Patient education in Rheumatoid Arthritis, sponsored by Universiti Sains Malaysia. Completed at 2 sites in Pakistan. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-24.

Sponsored by Universiti Sains Malaysia · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
376
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Rheumatoid Arthritis

Keywords

  • Patient education
  • Rheumatoid arthritis
  • Knowledge
  • Attitudes
  • Practice
03

In context

Arthritis, Rheumatoid

3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.

This study's enrollment of 376 is above the median of 96 across 2,220 interventional studies indexed under Arthritis, Rheumatoid.

Browse Arthritis, Rheumatoid studies →

Lead sponsor

Universiti Sains Malaysia is the lead sponsor of 177 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
376 participants (actual)

Study arms

  • Experimental
    Patient Education Group

    Patients will be provided with disease education literature

    Behavioral: Patient education

  • No intervention
    Normal Group

    Patients will not be provided with disease education literature

Interventions

  • BehavioralPatient education

    Rheumatoid arthritis patients will be provided with disease education literature

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months

Secondary outcomes

  1. 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

    Time frame: 3 months

07

Study locations

2 sites
  • Clifton Central Hospital
    Karachi, Sindh 75600, Pakistan
  • Liaqat National Hospital
    Karachi, Sindh, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03336684
Responsible party
Atta Abbas Naqvi (Research Assistant, Universiti Sains Malaysia) — Principal investigator
First posted
Nov 8, 2017
Start date
Dec 18, 2017
Primary completion
May 31, 2019
Completion
Jun 30, 2019
Last update
Mar 24, 2020

Study contacts

Mehfooz Alam, MBBS
principal investigator · Liaqat National Hospital Karachi
Baqir S Naqvi, PhD
study director · Hamdard University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion