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Trial registered on ANZCTR


Registration number
ACTRN12616000803493
Ethics application status
Approved
Date submitted
5/05/2016
Date registered
20/06/2016
Date last updated
25/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The simple avatar-based application to improving heart attack knowledge education
Scientific title
The evaluation of an avatar-based education application for improving knowledge on symptom recognition and response management in patients with acute coronary syndrome
Secondary ID [1] 289141 0
none
Universal Trial Number (UTN)
U1111-1182-6278
Trial acronym
A Simple avatar-based Application for improving heart attack education: SAVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute coronary syndrome 298645 0
Condition category
Condition code
Cardiovascular 298707 298707 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The education tool (i.e., the app) that will be used in this project is a simple and interactive avatar-based education application (app). The app will be designed specifically for this project. The app contents divided into four sections;1) Heart attack waring sign quiz, 2) Heart attack signs and symptoms, 3) What to do when heaving heart attack, and 4) heart attack warning sign test. Participant can select module section that are presented by nurse avatar by choosing a section that is of interest and with no limits placed on the number of times each section can be selected. The app will enhance patient learning by minimising the need for reading, and by using modern computerized tools such as animation, voice and touch screen response; also, there will be no complex medical terminology used in the app
The development of the avatar based education app for teaching heart attack recognition and management was conducted using the participatory cyclic action research . This project represents a multidisciplinary collaboration, and includes cardiovascular researchers and Information Technology (IT) experts, a cardiovascular experts, as well as consumers (individuals with heart condition).
The content of the avatar based education app was developed by a panel of clinical and research experts consisting of cardiac nurse practitioner, cardiac nurse educator, cardiac rehabilitation nurse and cardiac research academic at Flinders Medical Centre and Integrated Cardiovascular Clinical Network South Australia (iCCnet CHSA). Researchers prepared the contents of the storyboard to application development based on the Australian National Heart Foundation Heart Attack Action Plan. The expert panel was met for one hour at the beginning of the project to review the contents storyboard, formulate recommendations for the content of the avatar based app.
Design: A pragmatic randomised controlled trial with a six-month follow-up.
Method: A total of 70 participants will be recruited from the cardiac care unit of Flinders Medical Centre. Patients are eligible to participate if they 1) have a confirmed heart condition diagnosis and previous experience of chest pain or other heart attack symptoms, 2) are clinically stable and 3) can communicate in English and follow the study protocol. Patients who 1) are clinically unstable, 2) are significantly cognitively impaired and 3) unable to give informed consent will be excluded.
Written consent will be obtained from all participants. Eligible patients will be randomly allocated to either the usual care or intervention groups by a computer generated random allocation sequence.
Usual care: Usual care means the care received by a patient specific to his or her diagnosis. As part of the usual care, participants will receive medical and nursing management, advice on lifestyle and behaviour modification, education on their diagnosis, procedures, risk factors, emergency chest pain plans and the ‘My heart, my life’ and ‘Living with chronic heart failure’ booklets. Phase I and phase II cardiac rehabilitation programs will also be introduced to participants by cardiac rehabilitation co-ordinator.
Intervention: In addition to usual care, the intervention group participants will be asked to use the app before they are discharged from the hospital. The app is an interactive tablets style based education resource that utilises avatar, animation, voices and touch screen responses to teach patients about heart attack symptoms and response. Participants in the intervention group will receive the usual care plus the avatar-based education application (the app). Once randomisation, a tablet will be provide to all intervention group participants to view the app and to take home for the study period. 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 hospital. It will take approximately 10 minutes to go through the app and an additional 10 minutes to complete the associated baseline surveys (i.e., ACS index and satisfaction survey). Participant will be encouraged to use the app after hospital discharge, during the follow-up period. Two telephone follow-up calls (at one month and six months) will be scheduled with the participants before they are discharged from the hospital. The purpose of the telephone follow-up is to obtain information on implementation of the heart attack action plan and administer the Acute Coronary Syndrome (ACS) Response Index, Heart Attack Action Plan Survey and Health Services Utilisation questionnaires. The total duration of the study period is 6 months.
Outcome measurements: Previously validated surveys and researcher-developed questions will be administered to the participants at baseline, immediately after using the app (intervention group only) and at one and six months of telephone follow-up to assess their knowledge on and response to heart attack symptoms. Intervention group participants will also complete a satisfaction survey to assess their perceptions of the app. Between-group comparison will be performed for baseline, one-month and six-month instrument scores to evaluate the effect of the app.




Intervention code [1] 294655 0
Treatment: Devices
Comparator / control treatment
Usual care in this study means care specific to a patient’s diagnosis. Usual care at the study site will include bedside education in order to reinforce the diagnosis, procedures and risk factor management by bedside nurse. Bedside nurses will provide education about emergency chest pain and heart attack symptom action plans and about how to use the angina medicine. As part of usual care, the educational booklet (Heart Foundation’s My heart, my Life) and/or Living well with chronic heart failure) will be provided to all patients. Moreover, the patients will be introduced to the cardiac rehabilitation co-ordinator for information regarding phase I and phase II cardiac rehabilitation programs before they are discharged from the hospital.
Control group
Active

Outcomes
Primary outcome [1] 298190 0
Knowledge of heart attack symptoms as assessed by the Knowledge sub-scale of the ACS Response Index. The ACS Response Index is a validated instrument for assessing patients’ knowledge, attitudes and beliefs about heart attack symptoms. It includes 21 knowledge subscales,six attitudes subscales and seven beliefs subscales.
Timepoint [1] 298190 0
at one month and six months post discharge from hospital
Secondary outcome [1] 323440 0
Attitudes as assessed by the attitudes sub-scale of the ACS Response Index.
Timepoint [1] 323440 0
at one month and six months post discharge from hospital
Secondary outcome [2] 323921 0
Beliefs as assessed by the beliefs sub-scale of the ACS Response Index.
Timepoint [2] 323921 0
at one month and six months post discharge from hospital
Secondary outcome [3] 323922 0
Response to heart attack symptoms as assessed by Heart Attack Action Plan Survey
Timepoint [3] 323922 0
at one month and six months post discharge from hospital
Secondary outcome [4] 323923 0
Health Services Utilisation as assessed by Health Services Utilisation Survey
Timepoint [4] 323923 0
at one month and six months post discharge from hospital
Secondary outcome [5] 323924 0
Participants’ satisfaction as assessed by SAVE Satisfaction Questionnaire
Timepoint [5] 323924 0
at one month and six months post discharge from hospital
Secondary outcome [6] 335275 0
symptom recognition as assessed by the symptom recognition sub-scale of the ACS Response Index.
Timepoint [6] 335275 0
at one month and six months after randomization

Eligibility
Key inclusion criteria
Admitted with any cardiac diagnosis where chest pain or other heart attack symptoms have been experienced previously
Clinically stable
Normal cognitive function Sufficient English language ability to communicate and to follow the study procedure
Minimum age
18 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clinically unstable
Cognitive impairment
Failure 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)
The Excel file containing allocation sequences will be password protected and only accessible to an administrative assistant (randomisation service) who is based externally to the study site and who will not be involved in the process of recruitment, implementation and data analysis.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation sequence will be generated by the Excel computer software program. Participants’ detail will be recorded with their group allocation in a secure file only accessible to the administrative assistant responsible for randomisation.
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
The require sample size per group was calculated to be 31 (alpha=0.05, power=0.95) this calculation was performed using the independent sample t-test and test by Power Analysis and Sample Size (PASS) software. When taking into account a 10% attrition rate, 70 participants (35 per group) must be enrolled in the study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 5814 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 13210 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 293509 0
University
Name [1] 293509 0
Flinders University
Address [1] 293509 0
Flinders University Sturt Road Bedford Park Adelaide SA 5042
Country [1] 293509 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
School of Nursing and Midwifery Flinders University Sturt Road Bedford Park Adelaide SA 5042
Country
Australia
Secondary sponsor category [1] 292337 0
None
Name [1] 292337 0
Address [1] 292337 0
Country [1] 292337 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294956 0
sountern adelaide clinical human research ethics committee
Ethics committee address [1] 294956 0
Flinders Medical Centre / The Flats F6/F8 Flinders Drive, Bedford Park SA 5042
Ethics committee country [1] 294956 0
Australia
Date submitted for ethics approval [1] 294956 0
16/06/2015
Approval date [1] 294956 0
26/04/2016
Ethics approval number [1] 294956 0
OFR#290.15-HREC/15/SAC/247

Summary
Brief summary
Background and aim: Lack of knowledge on heart attack symptoms and delay in seeking medical treatment are evident in the literature. Because 47% of the Australian general public is functionally illiterate, gaining medical information through traditional booklets and brochures can be challenging for those with a low literacy level. This project aims to evaluate an interactive, avatar-based education application (the app) to improve patients’ knowledge on and response to heart attack symptoms.

Design: A pragmatic randomised controlled trial with a six-month follow-up
Method:
A total of 70 participants will be recruited from the cardiac care unit of Flinders Medical Centre. Patients are eligible to participate if they 1) have a confirmed heart condition diagnosis and previous chest pain experience, 2) are clinically stable and 3) can communicate in English and follow the study protocol. Patients who 1) are clinically unstable, 2) are significantly cognitively impaired and 3) unable to give informed consent will be excluded.

Written consent will be obtained from all the participants. Eligible patients will be randomly allocated to either the usual care or intervention groups by a computer-generated random allocation sequence that is accessible only to the administration staff responsible for randomisation.

Usual care: Usual care means the healthcare services received by a patient specific to his/her diagnosis. The participants will receive in-patient cardiac rehabilitation, a part of the usual care at the study site, such as medical and nursing management, advice on lifestyle and behaviour modification and receipt of the ‘My Heart My Life’ booklets.

Intervention: In addition to usual care, the intervention group participants will be asked to use the app before they are discharged from the hospital. The app is an interactive iPad-based education resource that utilises avatar, animation, voices and touch screen responses to teach patients about heart attack symptoms and response. Minimal text and medical terminology are used in the app.

Outcome measurements: Previously validated surveys and researcher-developed questions will be administered to the participants at baseline, immediately after using the app (intervention group only) and at one and six months of telephone follow-up to assess their knowledge on and response to heart attack symptoms. Intervention group participants will also complete a satisfaction survey to assess their perceptions of the app.

Between-group comparison will be performed for baseline, one-month and sixth-month survey scores to evaluate the effect of the app. Data analysis will be conducted by a senior statistician.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65622 0
Prof Robyn A Clark
Address 65622 0
School of Nursing and Midwifery
Flinders University
Sturt Road Bedford Park
South Australia 5042
Country 65622 0
Australia
Phone 65622 0
+61 8201 3266
Fax 65622 0
+6682761602
Email 65622 0
robyn.clark@flinders.edu.au
Contact person for public queries
Name 65623 0
Prof Robyn A Clark
Address 65623 0
School of Nursing and Midwifery
Flinders University Sturt campus
Bedford Park
South Australia 5042
Country 65623 0
Australia
Phone 65623 0
+61 8201 3266
Fax 65623 0
+6682761602
Email 65623 0
robyn.clark@flinders.edu.au
Contact person for scientific queries
Name 65624 0
Dr Hui Du
Address 65624 0
School of Nursing and Midwifery
Flinders University Sturt campus
Sturt Road Bedford Park
South Australia 5042
Country 65624 0
Australia
Phone 65624 0
+61 8201 2997
Fax 65624 0
+61 8276 1602
Email 65624 0
du0070@flinders.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary