ANZCTR - Registration

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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]

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

Condition category

Condition code

Cardiovascular

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]

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]

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]