Rheumatoid ArthritisERADELNCT03336684
Evaluation of Rheumatoid Arthritis Disease Education Literature
A study testing Patient education in people with Rheumatoid Arthritis, run by Universiti Sains Malaysia at 2 sites in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Patient education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 376 participants
- Where
- 2 sitesPakistan
- Study dates
- 18 Dec 2017to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Out-patients with established diagnosis of rheumatoid arthritis over 3 months.
- Participants who are willing to participate in the study.
Who cannot join
- Patients with no rheumatoid arthritis.
- Patients currently undergoing surgery or had previous history of surgery.
- Patients who are not willing to participate.
- In-patients.
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Clifton Central Hospital
Karachi, Sindh, 75600
Liaqat National Hospital
Karachi, Sindh
About this study
Official title: 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Patient education
- Keywords
- Patient education, Rheumatoid arthritis, Knowledge, Attitudes, Practice
- Medical subject headings
- Arthritis, Rheumatoid, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient educationBehavioural
Rheumatoid arthritis patients will be provided with disease education literature
| Study group | Role | What they receive |
|---|---|---|
| Patient Education Group | Experimental | Patients will be provided with disease education literature Receives: Behavioral: Patient education |
| Normal Group | No intervention | Patients will not be provided with disease education literature |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start18 Dec 2017
- Primary completion31 May 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atta Abbas Naqvi, Universiti Sains Malaysia
- Investigators
- Mehfooz Alam, MBBS, Principal investigator, Liaqat National Hospital KarachiBaqir S Naqvi, PhD, Study director, Hamdard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03336684
- Sponsor's protocol ID
- PACT2
- Acronym
- ERADEL
- Status last verified
- Mar 2020
- First submitted
- 31 Oct 2017
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Rheumatoid Arthritis Disease Education Literature: The ERADEL Trial
- ClinicalTrials.gov ID
- NCT03336684
- Acronym / sponsor ID
- ERADEL / PACT2
- Conditions
- Rheumatoid Arthritis
- Keywords
- Patient education, Rheumatoid arthritis, Knowledge, Attitudes, Practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 18 Dec 2017 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 8 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Education Group | Experimental | Behavioral: Patient educationPatients will be provided with disease education literature |
| Normal Group | No intervention | –Patients will not be provided with disease education literature |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Out-patients with established diagnosis of rheumatoid arthritis over 3 months.
- Participants who are willing to participate in the study.
Key exclusion criteria (4 listed)
- Patients with no rheumatoid arthritis.
- Patients currently undergoing surgery or had previous history of surgery.
- Patients who are not willing to participate.
- In-patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient educationRheumatoid arthritis patients will be provided with disease education literature | Behavioural | Patient Education Group |
Primary outcome
Patient knowledge about rheumatoid arthritis
Time frame: 3 months
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.
1 secondary outcome
Patient satisfaction
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehfooz Alam, MBBS principal investigator
Liaqat National Hospital Karachi
Baqir S Naqvi, PhD study director
Hamdard University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient education in people with Rheumatoid Arthritis, run by Universiti Sains Malaysia at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient knowledge about rheumatoid arthritis (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.