Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000512123
Ethics application status
Approved
Date submitted
25/03/2019
Date registered
29/03/2019
Date last updated
29/03/2019
Date data sharing statement initially provided
29/03/2019
Date results provided
29/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of 'Teach-back', a simple communication tool, on disease knowledge in people with chronic hepatitis B
Scientific title
Health Literacy and Chronic Hepatitis B: Using teach-­back to improve patient understanding.
– a randomized controlled study
Secondary ID [1] 297767 0
Nil known
Universal Trial Number (UTN)
U1111-1230-4054
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic hepatitis B 312106 0
Condition category
Condition code
Oral and Gastrointestinal 310665 310665 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Infection 310739 310739 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group received a once-off education session prior to their routine liver clinic outpatient appointment, run by a trained investigator, using the teach-back strategy. This session involved a discussion between the investigator and participant on the four domains of CHB – transmission, natural history, epidemiology and prevention and clinical management; supported by simple explanations and images using an educational resource specifically developed for people with low health literacy. This session continued until the participant had adequate understanding of each aspect covered, which ranged from 15-45 minutes. Information was explained using plain language and medical jargon avoided. After covering each concept, the investigator would use teach-back to confirm patient understanding, for example: ‘To check that I have explained the information clearly, could you please tell me how hepatitis B is spread?’. If the answers were wrong or incomplete, the investigator would re-explain the concept and reassess until the participant understood the information.

The trained investigator was a final year medical student, who had received training to facilitate the 'teach-back' intervention from the viral hepatitis nurse.
Intervention code [1] 313999 0
Other interventions
Comparator / control treatment
All participants in both study arms would first complete a questionnaire to assess their baseline knowledge of hepatitis B. Participants in the control group did not have a teach-back education session and would attend their routine liver clinic outpatient appointment as scheduled.
Control group
Active

Outcomes
Primary outcome [1] 319507 0
Participant’s score on a questionnaire consisting of 23 true or false questions covering four domains of HBV – transmission, natural history, epidemiology and prevention and clinical management. This was a modified, validated questionnaire from a previous study assessing understanding in patients living with chronic hepatitis B.

Source of validated questionnaire:
Hajarizadeh B, Wallace J, Richmond J, Ngo N, Enright C. Hepatitis B knowledge and associated factors among people with chronic hepatitis B. Aust NZJ Public Health. 2015;39(6):563-568.
Timepoint [1] 319507 0
Baseline, immediately after intervention and 1-month post-intervention
Secondary outcome [1] 368511 0
Nil
Timepoint [1] 368511 0
Nil

Eligibility
Key inclusion criteria
English-speaking patients aged 18 years or greater and diagnosed with chronic hepatitis B were eligible for the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects will be excluded from the study for the following criteria:
1. Decompensated liver disease
2. Unwilling / unable to participate in a questionnaire
3. Non-English speaking patients
4. Withdraws from study

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



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics were reported as mean ± standard deviation (SD) or median (interquartile range) for continuous data, and statistical summaries were reported as counts and percentages of participants with a positive response for categorical data. Group equivalence was assessed by the Chi-square test and Fisher exact test on categorical variables and independent sample t-test on continuous variables. The intervention and control group knowledge scores were compared by paired t-test and analysis of variance (ANOVA) for normally distributed data and by Wilcoxon signed rank test for non-normally distributed data. Linear regression was conducted to detect associations between knowledge scores and sociodemographic characteristics. Variables that reached statistical significance (p=0.05) and those that showed a trend towards association with knowledge score (p=0.1 was accepted), were included in the multivariate model. All analyses were performed on an intent-to-treat basis and included all enrolled participants. In all cases, comparisons were two-tailed and a p-value of =0.05 was considered statistically significant. Data was analysed using SPSS software version 23 (IBM, New York, 2015).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/02/2017
Date of last participant enrolment
Anticipated
Actual
12/05/2017
Date of last data collection
Anticipated
Actual
12/06/2017
Sample size
Target
100
Accrual to date
Final
70
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13457 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 26064 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 302288 0
Hospital
Name [1] 302288 0
St Vincent's Hospital Melbourne
Country [1] 302288 0
Australia
Funding source category [2] 302291 0
University
Name [2] 302291 0
The University of Melbourne
Country [2] 302291 0
Australia
Primary sponsor type
Individual
Name
Alexander Thompson
Address
St Vincent's Hospital Melbourne
41 Victoria Parade, Fitzroy, Victoria 3065
Country
Australia
Secondary sponsor category [1] 302167 0
None
Name [1] 302167 0
Nil
Address [1] 302167 0
Nil
Country [1] 302167 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302965 0
St Vincent's Hospital Melbourne - Human Ethics Research Committee
Ethics committee address [1] 302965 0
Ethics committee country [1] 302965 0
Australia
Date submitted for ethics approval [1] 302965 0
22/11/2016
Approval date [1] 302965 0
21/12/2016
Ethics approval number [1] 302965 0
LRR 203/16

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

Contacts
Principal investigator
Name 92002 0
Prof Alexander Thompson
Address 92002 0
St. Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy
Victoria
3065
Country 92002 0
Australia
Phone 92002 0
+61 03 92312211
Fax 92002 0
Email 92002 0
[email protected]
Contact person for public queries
Name 92003 0
Sophie Tran
Address 92003 0
St. Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy
Victoria
3065
Country 92003 0
Australia
Phone 92003 0
+61 03 9231 2211
Fax 92003 0
Email 92003 0
[email protected]
Contact person for scientific queries
Name 92004 0
Sophie Tran
Address 92004 0
St. Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy
Victoria
3065
Country 92004 0
Australia
Phone 92004 0
+61 03 9231 2211
Fax 92004 0
Email 92004 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1711Informed consent form    377236-(Uploaded-25-03-2019-09-03-12)-Study-related document.docx
1712Study protocol    377236-(Uploaded-25-03-2019-09-03-46)-Study-related document.docx
1713Ethical approval    377236-(Uploaded-25-03-2019-09-05-09)-Study-related document.pdf



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.