Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001680156
Ethics application status
Approved
Date submitted
7/09/2019
Date registered
29/11/2019
Date last updated
31/05/2021
Date data sharing statement initially provided
29/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Educational intervention to monitor the change in Quality of life of Hepatitis C patients
Scientific title
A quasi controlled study to monitor the impact of educational intervention on Quality of life of hepatitis C patients
Secondary ID [1] 299198 0
None
Universal Trial Number (UTN)
U1111-1239-7383
Trial acronym
Linked study record
The parent study is registered in Open ICSPR repository” under the code "Openicpsr-109921".
This is the raw data and was deposited under this code but the paper submitted is under review and not published yet.

Health condition
Health condition(s) or problem(s) studied:
Role limitation due to physical health 314303 0
Role limitation due to emotional health 314307 0
Hepatitis C 314995 0
Condition category
Condition code
Public Health 312657 312657 0 0
Health promotion/education
Oral and Gastrointestinal 313636 313636 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Infection 313637 313637 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be listened to and educated about preventive measures, transmission risk factors, early signs and symptoms of HCV infection, hygienic control, safe use of toiletries, counselled to reduce their emotional distress and encouragement to have active social and functional life. Single educational sessions will be conducted by the university research student and Hepatologist and the participants will be allowed to contact them for asking any querries regarding their condition. This intervention will be an addition to standard DAA therapy.
Educational sessions will last from fifteen to thirty minutes, and second participants' interview/evaluation will be conducted one month after the intervention has been provided.
Intervention code [1] 315507 0
Lifestyle
Intervention code [2] 315925 0
Behaviour
Comparator / control treatment
No Control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321321 0
Change in quality of life of Hepatitis C patients through educational intervention.
This outcome will be monitored through pre-validated SF-36 quality of life questionnaire.
Timepoint [1] 321321 0
First interview will be conducted when the patients had received standard One month DAAs therapy.
Second interview will be conducted after 30 days of the educational session.
Secondary outcome [1] 374654 0
Nil
Timepoint [1] 374654 0
Nil

Eligibility
Key inclusion criteria
Adult HCV patients visiting the hospital's Heptitis clinic of sound mentality with confirmed HCV diagnosis through HCV RNA Polymerase Chain reaction (PCR) test.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients having major comorbidities like Diabetes, Neurological problems, Hypertension, Renal failure, hepatic failure, cardiac issues, all type of cancers, and physical and mental disabilities.
Age below 18 years of age will also be excluded from our study.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
WHO calculator with 5% Margin of Error and 95% Confidence level, and 4.5% prevalence of HCV in Pakistani population, sample size was calculated to be 67. We will take 80 participants to conduct the study for the probable loss of follow up.
Wilcoxon signed rank or paired sample t test will be used for before and after analysis. Moreover, regression analysis will be used to identify the underlying factor responsible for the change in patient's quality of life. One Way ANOVA or Kruskall Wallis tests will be used for differences in independent variable of the participants.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/11/2019
Date of last participant enrolment
Anticipated
13/12/2019
Actual
31/01/2020
Date of last data collection
Anticipated
10/01/2020
Actual
28/02/2020
Sample size
Target
80
Accrual to date
Final
78
Recruitment outside Australia
Country [1] 21843 0
Pakistan
State/province [1] 21843 0
Khyber Pakhtunkhwa

Funding & Sponsors
Funding source category [1] 303738 0
Self funded/Unfunded
Name [1] 303738 0
N/A
Country [1] 303738 0
Primary sponsor type
Individual
Name
Shahan Ullah
Address
Shahan Ullah
Department of Pharmacy, University road, Quaid-i-Azam University Islamabad
Country
Pakistan
Secondary sponsor category [1] 303871 0
None
Name [1] 303871 0
Address [1] 303871 0
Country [1] 303871 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304263 0
Bio-Ethical COmmittee Quaid-i-Azam University Islamabad
Ethics committee address [1] 304263 0
Ethics committee country [1] 304263 0
Pakistan
Date submitted for ethics approval [1] 304263 0
30/01/2017
Approval date [1] 304263 0
02/02/2017
Ethics approval number [1] 304263 0
BEC-FBS-QAU-104

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96330 0
Mr shahan ullah
Address 96330 0
Department of Pharmacy, University road, Quaid-i-Azam University Islamabad
Country 96330 0
Pakistan
Phone 96330 0
+923146938002
Fax 96330 0
N/A
Email 96330 0
[email protected]
Contact person for public queries
Name 96331 0
shahan ullah
Address 96331 0
Department of Pharmacy, University road, Quaid-i-Azam University Islamabad
Country 96331 0
Pakistan
Phone 96331 0
+923146938002
Fax 96331 0
N/A
Email 96331 0
[email protected]
Contact person for scientific queries
Name 96332 0
shahan ullah
Address 96332 0
Department of Pharmacy, University road, Quaid-i-Azam University Islamabad
Country 96332 0
Pakistan
Phone 96332 0
+923146938002
Fax 96332 0
N/A
Email 96332 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
After de-identification, participants data underlying the published study results will be shared
When will data be available (start and end dates)?
Data will be available for publication by February 20, 2020.
There is no end date for the availability of data, however the patients particulars will be coded for confidentiality purposes.
Available to whom?
Data will be available at the discretion of primary investigator on case by case basis, upon request.
Available for what types of analyses?
All type of studies.
How or where can data be obtained?
After publication, the data will be with prime investigator, and upon request the data will be shared.
Emails to reach the prime investigator are
[email protected]
[email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.