NCT03336684

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
376

participants targeted

Target at P75+ for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 8, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

December 18, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

1.4 years

First QC Date

October 31, 2017

Last Update Submit

March 23, 2020

Conditions

Rheumatoid Arthritis

Keywords

Patient educationRheumatoid arthritisKnowledgeAttitudesPractice

Outcome Measures

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.

    3 months

Secondary Outcomes (1)

  • Patient satisfaction

    3 months

Study Arms (2)

Patient Education Group

EXPERIMENTAL

Patients will be provided with disease education literature

Behavioral: Patient education

Normal Group

NO INTERVENTION

Patients will not be provided with disease education literature

Interventions

Patient educationBEHAVIORAL

Rheumatoid arthritis patients will be provided with disease education literature

Patient Education Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clifton Central Hospital

Karachi, Sindh, 75600, Pakistan

Location

Liaqat National Hospital

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Arthritis, RheumatoidBehavior

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Mehfooz Alam, MBBS

    Liaqat National Hospital Karachi

    PRINCIPAL INVESTIGATOR

  • Baqir S Naqvi, PhD

    Hamdard University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The investigator will be blinded from randomization and recruitment process.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

October 31, 2017

First Posted

November 8, 2017

Study Start

December 18, 2017

Primary Completion

May 31, 2019

Study Completion

June 30, 2019

Last Updated

March 24, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

PA(2)