Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001403325
Ethics application status
Approved
Date submitted
30/09/2017
Date registered
4/10/2017
Date last updated
3/03/2020
Date data sharing statement initially provided
6/03/2019
Date results provided
3/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the effectiveness of an interactive avatar-based education application for improving heart failure patients’ knowledge and self-care behaviours: A pragmatic randomised controlled trial
Scientific title
Evaluation of the effectiveness of an interactive avatar-based education application for improving heart failure patients’ knowledge and self-care behaviours: A prospective open-label pragmatic multicentre randomised controlled trial
Secondary ID [1] 291648 0
Nil
Universal Trial Number (UTN)
U1111-1202-7701
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart failure 302797 0
Condition category
Condition code
Cardiovascular 302296 302296 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Brief name
Fluid Watchers
2. Why
Avatar-based technologies for supporting education are an innovative approach for patients with low literacy, low health literacy and English as a second language. The use of avatar technology for patient education have shown benefit in chronic diseases such as cancer, diabetes and depression for improving knowledge, self-care behaviours and quality of life. Research has demonstrated positive outcomes in clinical practice. However this technology has not been evaluated among patients with HF.
3. What (Material)
A tablet computer will be provided to all intervention group participants to view the app and to take home for the study period.
4. What (Procedure)
Once participants are assigned to the avatar-based education group, a research nurse will provide them a tablet computer with the app installed. The research nurse will provide explanations and instructions to participants on how to use the avatar-based education application. Participants in this group will be asked to use the app before they are discharged from heart failure clinic. The app will be provided information about heart failure and self-care. After that, the research nurse will ask them some questions regarding the information provided and their thoughts about the app.
5. Who provided
This study intervention is a self-administered avatar-based education application. The avatar-based education application is installed on a tablet computer. The research nurse will provide a tablet computer to the participant to use the app during the six-month study period.
6. How
The avatar-based education application will be presented to the participants in the intervention group. The participant will be asked to review the app and the research nurse will assist the participant to become familiar with using the app before participant take the app home to use during six-month study period.
7. Where
The avatar-based education application will be provided to participants to use at their own time. The application is installed on a tablet computer, and does not require internet for operation. Participants can review the app at any time and any location that is convenient to them.
8. When and How much
Participants will be encouraged to use the app as often as they like during the six-month study period. Two telephone follow-up calls (at one-month and six-month) will be scheduled with the participants. Information on the number of times the participant has reviewed the app will be collected during the follow-up telephone calls.
9. Tailoring
The avatar-based education application contains information on heart failure and heart failure self-care, based on the Heart Foundation, “Living well with heart failure” booklet. When using the app, the participant can make and customise their own avatar and the participant can skip sections of the app, or repeat sections, and can exist at any point, based on their individual needs. Page logic is also built in the app, and are specific for individual patient based on their answer to a specific question. For example, is the participant answers “no” to the question, “if you have a pace maker?”, then the app will skip the pacemaker information section. However, the participant can choose to view that section later, if they still would like to learn about pacemaker, despite they do not have one.
10. Modification
The education app was developed through an action research. It has been reviewed by clinical research, research and academic experts in the area of HF. Any errors and glitches in the app reported by research nurse or the participant will be forward to the IT experts for immediate modification. We do not foresee a modification that would be required on the contents of the education app.
11. How well (Planned)
The frequency of using the avatar-based education application will be assessed by asking participants and recording in tablet for confirmation of the data.
12. How well (Action)
The intervention is a self-administered education application. The number of times that participants reviewed the app will be collected during the telephone follow-up.
Intervention code [1] 297734 0
Treatment: Devices
Comparator / control treatment
Usual care at the study site includes heart failure nurses or regular nurses led-bedside education in order to reinforce the diagnosis, treatment, self-care, self-monitoring and follow-up by heart failure nurse at heart failure clinic. As part of usual care, the educational booklet from Heart Foundation “Living every day with my heart failure” and/or “Living well with heart failure” will be provided to all patients. Patients will be followed-up at one month and six months post discharge from hospital.
Control group
Active

Outcomes
Primary outcome [1] 301704 0
Knowledge
Knowledge will be assessed with the Dutch Heart Failure Knowledge (DHFKS).
Timepoint [1] 301704 0
Baseline, 1-month (primary timepoint) and 3-month
Secondary outcome [1] 333624 0
Self-care behaviours
Self-care behaviours will be assessed with The Self-care Heart Failure Index (SCHFI) Version 6.2.
Timepoint [1] 333624 0
Baseline, 1-month and 3-month
Secondary outcome [2] 333625 0
Readmission
Readmission will be assessed for HF-cause readmission including both emergency and elective admissions to hospital and unplanned visit general physician units as measured by self-reporting and review of the medical records for verification of the information.
Timepoint [2] 333625 0
Baseline, 1-month and 3-month
Secondary outcome [3] 339083 0
Satisfaction
Satisfaction will be assessed by the investigator developed Avatar-based application satisfaction questionnaire, which is adapted from validated education material acceptability surveys.
Timepoint [3] 339083 0
Baseline, 1-month and 3-month

Eligibility
Key inclusion criteria
1. A confirmed diagnosis of HF
2. Individuals with a newly diagnosed HF within 1 year; with a previous hospitalisation for HF
2. New York Heart Association Functional Class (NYHA-FC) I-IV
3. Normal cognitive function. Normal cognitive function is defined as a score of 26 or higher on the Montreal Cognitive Assessment (MOCA-Test).
4. Sufficient English language ability to communicate and to follow the study procedure
5. Willing to give informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Clinically unstable. Clinically unstable is defined as patients who do not achieve the five normal vital signs (i.e. heart rate, systolic blood pressure, respiratory rate, oxygen saturation, and temperature) plus normal mental status and ability to eat, for at least 24 hours prior to enrol in the study.
2. Cognitive impairment
3. Refuse to give informed consent.

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)
In this study, randomisation will occur after consent and completion of baseline assessment. Allocation concealment will be ensured, as the service will not release the randomisation code until the patient has been recruited into the trial, which takes place after all baseline measurement have been completed. Two block sizes will be used, the block size is not disclosed, to ensure concealment of the numbers in each group at any time during the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
In this pragmatic randomised controlled trial, participants will be randomly assigned to either control or intervention group with a 1:1 ratio. Block randomisation sequence will be generated by a computer randomisation system by an independent Clinical trial management centre. Two random block sizes will be used.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
A prospective multi-centre, non-blinded randomized, two-armed parallel pragmatic controlled trial
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Sample size
The Dutch HF knowledge scale (DHFKS) was used as the primary outcome measure in this study. Based on a previous heart failure study (Delaney et al. 2013) to measure heart failure knowledge using the DHFKS with a standard deviation of 2.075, we estimated a sample size of 40 per group is needed with a 2-sided 5% significance level and 80% power (calculated using PASS 14 Power Analysis and Sample Size Software by a statistician). When taking into account a loss to follow up of 10%, 88 participants (44 per group) are required to be enrolled

Statistical methods
Data from this study will be analysed according to the intention-to-treat principle, in order to provide unbiased assessment of intervention effectiveness. Data will be analysed by using the statistics software - Statistic Package for Social Science (SPSS), version 22.
Descriptive statistics will be used to summarise the baseline demographic, clinical status, health literacy and mental status of participants. Continuous data are summarised using mean, median, standard deviation and standard error of the mean scores, whilst categorical data will be summarised in terms of percentages. The demographics of the participants in the intervention and usual care groups are compared using the independent sample t-test or Pearson’s Chi-square test, to measure differences. Continuous data with normal distribution are analysed using the independent t-test, and the Mann-Whitney U test will be used for non-normally distributed data. Association between categorical data are analysed using the Chi-square test.
When comparing the change in knowledge, self-care behaviours, readmission and satisfaction scores overtime and between groups, the statistical analysis will be used as following. Independent sample t test will be used for continuous variables, and Pearson’s Chi-square test for categorical data, to compare baseline, one-month and six-month follow-up, outcome measurements, between intervention and control groups. Paired t test will be used to compare changes over time in both groups, for outcome measurements, from baseline, one-month and six-month follow-up. A p value of <0.05 is considered statistically significant and all tests are two tailed. Data analysis will be supervised by a statistician who is not involved in screening, recruitment and follow-up of study participants.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2018
Actual
1/11/2018
Date of last participant enrolment
Anticipated
30/04/2019
Actual
21/05/2019
Date of last data collection
Anticipated
31/07/2019
Actual
21/08/2019
Sample size
Target
88
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 7809 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 7810 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [3] 7811 0
Noarlunga Health Service - Noarlunga Centre
Recruitment postcode(s) [1] 15742 0
5042 - Bedford Park
Recruitment postcode(s) [2] 15743 0
5011 - Woodville
Recruitment postcode(s) [3] 15744 0
5168 - Noarlunga Centre

Funding & Sponsors
Funding source category [1] 296145 0
University
Name [1] 296145 0
Flinders University
Country [1] 296145 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
College of Nursing and Health Sciences, Flinders University Sturt Road Bedford Park Adelaide SA 5042
Country
Australia
Secondary sponsor category [1] 295049 0
None
Name [1] 295049 0
Address [1] 295049 0
Country [1] 295049 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297393 0
the Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC)
Ethics committee address [1] 297393 0
Ethics committee country [1] 297393 0
Australia
Date submitted for ethics approval [1] 297393 0
06/07/2017
Approval date [1] 297393 0
16/02/2018
Ethics approval number [1] 297393 0
OFR 187.17-HREC/17/SAC268

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

Contacts
Principal investigator
Name 73906 0
Prof Robyn Clark
Address 73906 0
College of Nursing and Health Sciences
Flinders University Sturt campus
Bedford Park
South Australia 5042
Country 73906 0
Australia
Phone 73906 0
+61 8 8201 3266
Fax 73906 0
Email 73906 0
robyn.clark@flinders.edu.au
Contact person for public queries
Name 73907 0
Robyn Clark
Address 73907 0
College of Nursing and Health Sciences
Flinders University Sturt campus
Bedford Park
South Australia 5042
Country 73907 0
Australia
Phone 73907 0
+61 8 8201 3266
Fax 73907 0
Email 73907 0
robyn.clark@flinders.edu.au
Contact person for scientific queries
Name 73908 0
Robyn Clark
Address 73908 0
College of Nursing and Health Sciences
Flinders University Sturt campus
Bedford Park
South Australia 5042
Country 73908 0
Australia
Phone 73908 0
+61 8 8201 3266
Fax 73908 0
Email 73908 0
robyn.clark@flinders.edu.au

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


What supporting documents are/will be available?




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.