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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Date results information initially provided
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)
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

Study type
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

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
Timepoint [1] 368511 0

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
Both males and females
Can healthy volunteers participate?
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
Other design features
Not Applicable
Type of endpoint(s)
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 status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
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
Name [1] 302288 0
St Vincent's Hospital Melbourne
Address [1] 302288 0
41 Victoria Parade, Fitzroy, Victoria, 3065
Country [1] 302288 0
Funding source category [2] 302291 0
Name [2] 302291 0
The University of Melbourne
Address [2] 302291 0
Grattan Street, Parkville, Victoria, 3010
Country [2] 302291 0
Primary sponsor type
Alexander Thompson
St Vincent's Hospital Melbourne
41 Victoria Parade, Fitzroy, Victoria 3065
Secondary sponsor category [1] 302167 0
Name [1] 302167 0
Address [1] 302167 0
Country [1] 302167 0

Ethics approval
Ethics application status
Ethics committee name [1] 302965 0
St Vincent's Hospital Melbourne - Human Ethics Research Committee
Ethics committee address [1] 302965 0
Research Governance Unit
Level 5, Building E (Aikenhead Building)
27 Victoria Parade
Fitzroy VIC 3065
Ethics committee country [1] 302965 0
Date submitted for ethics approval [1] 302965 0
Approval date [1] 302965 0
Ethics approval number [1] 302965 0
LRR 203/16

Brief summary
Limited health literacy has great impact on patient health outcomes; poorer knowledge of disease is linked with suboptimal self-care, reduced treatment adherence and increased use of emergency services. Studies conducted to assess health literacy and patient understanding amongst patients living with chronic hepatitis B (CHB) have revealed gaps in disease-specific knowledge. Despite this, there are few studies evaluating strategies to improve patient knowledge of hepatitis B. The 'teach-back' strategy is a communication tool that has been shown to be successful in improving disease-specific knowledge in other areas of health. 'Teach-back' ensures the health provider checks for understanding with patients and then allowing opportunity for clarification. This study hypothesises that there is a poor baseline understanding amongst patients living with CHB and that the teach-back method will improve disease-specific knowledge. This would form the foundation for future studies to evaluate how improved understanding translates into greater health outcomes.
Trial website
Trial related presentations / publications
Public notes

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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 1711 0
Informed consent form
Citation [1] 1711 0
Link [1] 1711 0
Email [1] 1711 0
Other [1] 1711 0
Type [2] 1712 0
Study protocol
Citation [2] 1712 0
Link [2] 1712 0
Email [2] 1712 0
Other [2] 1712 0
Type [3] 1713 0
Ethical approval
Citation [3] 1713 0
Link [3] 1713 0
Email [3] 1713 0
Other [3] 1713 0
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Other publication details
Citation type [1] 1714 0
Conference abstract
Citation/DOI/link/details [1] 1714 0
Attachments [1] 1714 0
Results – basic reporting
Results – plain English summary