Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001598279
Ethics application status
Approved
Date submitted
12/09/2018
Date registered
26/09/2018
Date last updated
26/09/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the Cardihab Smartphone Application for the Delivery of Cardiac Rehabilitation
Scientific title
Evaluation of the Cardihab Smartphone Application for the Delivery of Cardiac Rehabilitation
Secondary ID [1] 296054 0
Nil Known
Universal Trial Number (UTN)
U1111-1220-2800
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac Rehabilitation 309622 0
Condition category
Condition code
Physical Medicine / Rehabilitation 308434 308434 0 0
Other physical medicine / rehabilitation
Cardiovascular 308579 308579 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cardiac Rehabilitation patients who are doing a home-based or partially home-based program will be offered access to a smart phone app- the Cardihab App - to use for their program. Patients will be monitored weekly for 6 weeks by cardiac rehabilitation clinicians and will be contacted by research staff to complete a questionnaire about the usability and acceptance of the app. 5 patients will be asked to consent to an interview about the usability and acceptance of the app.
The app involves entering own health data i.e. blood pressure, weight, a symptom diary, exercise levels and individual health goals. Patients can be provided with a blood pressure machine and/or scales if part of their care plan if they do not have their own machine or scales. Loaned machines can be linked to the app via Bluetooth.It also includes short video clips providing education and audio recordings for stress relief. Input would involve 10 minutes every day. Education videos consist of: Causes of angina, Causes of heart attack, Living with heart attack, Risk factors, What is a heart attack? with links to Food and Nutrition, Heart attack warning signs and The Heart Foundation literature. The app is available to participants as part of their 6 week cardiac rehabilitation program where they are monitored weekly when using the app. Thereafter the app will remain on their phone for their own reference and use.
All data entered in the app is captured on a portal accessed by the cardiac rehabilitation clinician who phones the patient each week to review progress.
Interviews will take place in a focus group, which will be facilitated by an experienced researcher and recorded by the PI.
Intervention code [1] 312496 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307403 0
Usability and acceptability of Cardihab smart phone app for cardiac rehabilitation patients will be a composite primary outcome to discover the patient's perspective. Assessed via Health-ITUES questionnaire, Design Questionnaire, Mobile Application Use questionnaire.
Usability and acceptability of app will be assessed by validated questionnaires adapted specifically for this population. References:
1, Schnall R., Cho H., Liu, J. (2018). Health Information Technology Usability Evaluation Scale (Health-ITUES) for usability assessment of mobile health technology a validation study. JMIR Mhealth And Uhealth ISSN: 2291-5222, 2018 Jan 05; Vol. 6 (1), pp. e4; Publisher: JMIR Publications Inc.; PMID: 29305343
2. Adapted from Reynoldson, C., Stones, C., Allsop, M., Gardner, P., Bennett, M.I., Closs, J., Jones, R., & Knapp, P. (2014). Assessing the Quality and Usability of Smartphone Apps for pain Self-management, Pain Medicine. 15 (6), p898-909
3. Sourced from: Beatty, A.L, Magnusson, S.L. Fortney, J.C. Sayre, G.G. Whooley, M.A. (2018). VA FitHeart, A Mobile App for Cardiac Rehabilitation Usability Study. JMIR Human Factors , Jan 15; Vol. 5 (1), pp. e3; Publisher: JMIR Publications Inc; PMID: 29335235. Adapted from: Venatesh V., Thong, J. & Xu, X. (2012). Consumer acceptance and use of information technology: extending the unified theory of acceptance and use of technology. MIS Q 157-178.

The focus group questionnaire is Adapted from: Cai, R.A., Beste, D., Chaplin, H., Varakliotis, S., Suffield, L., Josephs, F., Sen, D., Wedderburn, L.R., Ioannou, Y., Hailes, S.,Eleftheriou, D. (2015). Developing and Evaluating JIApp: Acceptability and Usability of a Smartphone App System to Improve Self-Management in Young People with Juvenile Idiopathic Arthritis. JMIR Mhealth Uhealth, Aug; 5(8): e21.
Timepoint [1] 307403 0
Two weeks after commencing use of app
Secondary outcome [1] 352268 0
Nil
Timepoint [1] 352268 0
Nil

Eligibility
Key inclusion criteria
18 years or older
Eligible to enrol in Metro South Chronic Disease Rehabilitation Service - Cardiac Rehabilitation Program
Access to personal smartphone mobile phone
Enrolled in Cardiac Rehabilitation Program using Cardihab
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to read English
Cognitive impairment (MMSE greater than or equal to 24)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics of range and mean will be used for demographics, clinical data and quantitative questionnaire responses. Qualitative interviews will be transcribed verbatim and coded using thematic analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
18/09/2018
Date of last participant enrolment
Anticipated
29/10/2018
Actual
Date of last data collection
Anticipated
12/11/2018
Actual
Sample size
Target
15
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 11835 0
Redland Hospital - Cleveland
Recruitment postcode(s) [1] 23963 0
4163 - Cleveland
Recruitment postcode(s) [2] 23964 0
4178 - Wynnum
Recruitment postcode(s) [3] 23965 0
4113 - Eight Mile Plains

Funding & Sponsors
Funding source category [1] 300642 0
Government body
Name [1] 300642 0
Healthcare Evaluation and Assessment of Technology team. Queensland Health
Country [1] 300642 0
Australia
Primary sponsor type
Individual
Name
Alaina Krumins
Address
Princess Alexandra Hospital
Ipswich Road
Woolloongabba Qld 4102
Country
Australia
Secondary sponsor category [1] 300157 0
None
Name [1] 300157 0
Address [1] 300157 0
Country [1] 300157 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301431 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 301431 0
Ethics committee country [1] 301431 0
Australia
Date submitted for ethics approval [1] 301431 0
03/07/2018
Approval date [1] 301431 0
24/08/2018
Ethics approval number [1] 301431 0
HREC/18/QPAH/503

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

Contacts
Principal investigator
Name 86970 0
Ms Alaina Kumins
Address 86970 0
Princess Alexandra Hospital
Ipswich Road
Woolloongabba Qld 4102
Country 86970 0
Australia
Phone 86970 0
+61 07 3488 3640
Fax 86970 0
Email 86970 0
[email protected]
Contact person for public queries
Name 86971 0
Alaina Kumins
Address 86971 0
Princess Alexandra Hospital
Ipswich Road
Woolloongabba Qld 4102
Country 86971 0
Australia
Phone 86971 0
+61 07 3488 3640
Fax 86971 0
Email 86971 0
[email protected]
Contact person for scientific queries
Name 86972 0
Alaina Kumins
Address 86972 0
Princess Alexandra Hospital
Ipswich Road
Woolloongabba Qld 4102
Country 86972 0
Australia
Phone 86972 0
+61 07 3488 3640
Fax 86972 0
Email 86972 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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Plain language summaryNo See report

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