Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001229864
Ethics application status
Approved
Date submitted
10/07/2020
Date registered
13/09/2021
Date last updated
13/09/2021
Date data sharing statement initially provided
13/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A mobile health application for people in remote and rural Queensland who have experienced a cardiovascular event.
Scientific title
A pilot randomised controlled study investigating the feasibility of a mobile health application to assist people in remote and rural Queensland who have experienced a cardiovascular event to complete rehabilitation at home.
Secondary ID [1] 299368 0
Nil known.
Universal Trial Number (UTN)
U1111-1240-8170
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 314540 0
Coronary Heart Disease 319020 0
Condition category
Condition code
Cardiovascular 312887 312887 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group: CARDIHAB© Mobile Health Application (mHealth app [includes weekly mentoring]) & standard care.

Materials will consist of the following: mobile phones, mHealth app and internet access, six-minute walk test (6MWT), Hospital Anxiety & Depression Scale (HADS), Adherence to Refills and Medications Scale (ARMS), 12-item Short Form Survey (SF-12v2), and Mobile App Rating Scale (MARS).

The mHealth app will be available to patients and will prospectively document the patient’s secondary prevention uptake and attendance, activity, record complications (e.g., angina), while also acting as a supportive measure with an automated message service. The mHealth app will act as a resource for home-based patient problem solving (e.g., angina identification & management). Participants will be remotely monitored by clinicians (i.e., cardiology team & practice nurses) and receive weekly mentoring for 6-weeks. The intervention will be administered to participants within one month post-discharge after experiencing a cardiac event. All intervention group participants will be referred to attend standard cardiac rehabilitation.

Participants will use their personal mobile phones and download the mHealth app with the guidance of an instruction sheet. Technical assistance will also be available via telephone if required.

A practice nurse will contact participants to: 1. randomise participants.

A research nurse will be blinded to the allocation sequence and only contact study participants to administer questionnaires as part of scheduled follow-up and undertake interviews (8-weeks).

The chief investigator (CI) will be unblinded to the allocation sequence to: 1. undertake weekly mentoring for 6-weeks as part of the mHealth app and program; 2. monitor participant data entry; & 3. contact participants experiencing complications to provide further assistance throughout the course of the intervention (6-weeks).

Weekly mentoring: involves participants receiving a 15-minute telephone call by a cardiology trained, registered nurse (the CI) surrounding heart health activities, the post-discharge period, cardiovascular health and well-being. Goal setting and education around different themes will also be undertaken as part of weekly mentoring and follow up.

On baseline assessment (time 1), participants will complete three questionnaires (HADS; ARMS; & SF-12v2) administered by a research nurse via telephone call. The research nurse will be blinded to the allocation sequence. Participants will also undertake a 6MWT. Participants will then enter data (i.e., blood glucose level, waist circumference, blood pressure) into the mHealth application on a daily basis for six weeks (approximately 10 minutes per day), and receive weekly mentoring as part of the program. At week 6 (time 2), the research nurse will contact participants via telephone to re-administer all three questionnaires and repeat the 6MWT. At week 8 (time 3), a semi-structured interview (30 minutes in duration) and the MARS instrument will be administered to intervention group participants by the research nurse to assess their experience, utility, usability and acceptability and quality of the cardiac rehabilitation mobile health technology.
Intervention code [1] 316173 0
Rehabilitation
Intervention code [2] 316174 0
Lifestyle
Comparator / control treatment
Control group: standard care only.

Standard care: consists of attending a validated, standardised secondary prevention program post-cardiac event (i.e., emotional support, education, physical activity, led by a multidisciplinary team).

Follow up: Participants will be followed-up by the research nurse who will administer a six-minute walk test (6MWT), and three questionnaires via telephone. The research nurse will be blinded to the study allocation sequence.

Questionnaires:
1. Hospital Anxiety & Depression Scale (HADS);
2.Adherence to Refills and Medications Scale (ARMS); &
3. 12-item Short Form Survey (SF-12v2).

At baseline assessment (time 1) and 6 weeks (time 2), standard care group participants will undertake all three questionnaires. Questionnaires will be administered via telephone by a research nurse. Participants will also undertake a 6MWT.
Control group
Active

Outcomes
Primary outcome [1] 322069 0
Composite primary outcome:
Evaluate the feasibility methods and procedures using pre-defined criteria for recruitment (>80% approached recruited), retention (>80% participants complete study), protocol fidelity (>90% of participants receive allocated intervention for entire study).
Timepoint [1] 322069 0
Outcome assessed when the last intervention group participant has completed the Mobile App Rating Scale (MARS) and undertaken a semi-structured interview (8 weeks post-randomisation).
Primary outcome [2] 322070 0
To evaluate daily adherence to remotely administered cardiac rehabilitation as measured by mHealth app analytics..
Timepoint [2] 322070 0
At completion of the trial when the last intervention group participant has entered data in the mHealth app at 6 weeks post-randomisation.
Primary outcome [3] 322071 0
To evaluate uptake to remotely administered cardiac rehabilitation as measured by mHealth app analytics.
Timepoint [3] 322071 0
At completion of the trial when the last intervention group participant has entered all data in the mHealth app at 6 weeks post-randomisation.
Secondary outcome [1] 377226 0
Anxiety and depressive symptoms: as measured by the Hospital Anxiety and Depression Scale (HADS).
Timepoint [1] 377226 0
Baseline; and 6 weeks post-randomisation.
Secondary outcome [2] 377227 0
Quality of Life (QOL): as measured by the 12-Item Short Form Health Survey (SF-12v2).
Timepoint [2] 377227 0
Baseline; and 6 weeks post-randomisation.
Secondary outcome [3] 383000 0
Medication adherence: as measured by the Adherence to Refills and Medications Scale (ARMS).
Timepoint [3] 383000 0
Baseline; and 6 weeks post-randomisation.
Secondary outcome [4] 383049 0
Functional capacity: as measured by the six-minute walk test (6MWT).
Timepoint [4] 383049 0
Baseline; and 6 weeks post-randomisation.
Secondary outcome [5] 387161 0
To evaluate user experience of the cardiac rehabilitation mobile health technology as measured by a one-on-one, audio recorded, semi-structured interview.
Timepoint [5] 387161 0
8 weeks post-randomisation.
Secondary outcome [6] 388725 0
To evaluate the quality of the cardiac rehabilitation mobile health app as measured by the MARS.
Timepoint [6] 388725 0
8 weeks post-randomisation.
Secondary outcome [7] 389060 0
Waist circumference as measured by app analytics.
Timepoint [7] 389060 0
Baseline; & weeks 1-6 post-randomisation.
Secondary outcome [8] 389062 0
Blood glucose level, as measured by app analytics.
Timepoint [8] 389062 0
Baseline; & weeks 1-6 post-randomisation.
Secondary outcome [9] 400855 0
Blood pressure, as measured by app analytics.
Timepoint [9] 400855 0
Baseline; & weeks 1-6 weeks post-randomisation.
Secondary outcome [10] 400856 0
Resting heart rate, as measured by app analytics.
Timepoint [10] 400856 0
Baseline; & weeks 1-6 weeks post-randomisation.

Eligibility
Key inclusion criteria
Must meet one or more of the following criteria: acute coronary syndrome; diagnostic procedure: coronary angiography with CAD; interventional procedure: primary or elective percutaneous coronary intervention (PCI); coronary artery bypass graft surgery; aged 18 years and over; living in a remote or rural location; understand or speak the English language; have a smartphone; & post-discharge internet access.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Child and/or young person (i.e., < 18 years of age);
2. Inability to understand or speak the English language;
3. Overseas resident and in Australia for <12 months;
4. Suffering from a mental illness/cognitive impairment & unable to legally
consent;
5. Pregnancy;
6. In an existing dependent or unequal relationship;
7. Highly dependent on medical care;
8. No smart phone; &
9. No internet access.

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)
Allocation concealment by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As per Hertzog (2008), 30 participants per group (N=60) will be recruited to this feasibility study. All randomised participants will be analysed on an Intention to Treat (ITT) basis. Statistical analysis of participants’ demographics and clinical characteristics will be employed by means of descriptive statistics (i.e., frequencies, percentages, means±SDs for continuous variables). Skewed data will be described using interquartile range (IQR). As this is a feasibility study, statistical significance is not expected to be found, Trends will provide preliminary data to support a large scale Randomised Controlled Clinical Trial (RCT). An analytic evaluation of participants’ interview transcripts and abductive approach to analysis will be used.

1. Hertzog, M. A. (2008). Considerations in determining sample size for pilot studies. Research in Nursing & Health, 31(2), 180-191. doi:10.1002/nur.20247

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/10/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 30192 0
4455 - Roma
Recruitment postcode(s) [2] 30193 0
4470 - Charleville
Recruitment postcode(s) [3] 30194 0
4720 - Emerald
Recruitment postcode(s) [4] 30195 0
4730 - Longreach
Recruitment postcode(s) [5] 30196 0
4725 - Barcaldine

Funding & Sponsors
Funding source category [1] 303884 0
University
Name [1] 303884 0
Menzies Health Institute Queensland (MHIQ)
Country [1] 303884 0
Australia
Primary sponsor type
University
Name
Menzies Health Institute Queensland (MHIQ)
Address
Menzies Health Institute Queensland
58 Parklands Drive
G40 Griffith Health Centre, Level 8.86
Gold Coast campus
Griffith University
Southport QLD 4222
Country
Australia
Secondary sponsor category [1] 304617 0
Commercial sector/Industry
Name [1] 304617 0
Queensland Cardiovascular Group
Address [1] 304617 0
PO Box 525
Spring Hill, QLD 4004
Country [1] 304617 0
Australia
Secondary sponsor category [2] 304618 0
Commercial sector/Industry
Name [2] 304618 0
Heart of Australia
Address [2] 304618 0
Level 1, 109 Honour Ave
Chelmer, QLD 4068
Country [2] 304618 0
Australia
Secondary sponsor category [3] 304619 0
Commercial sector/Industry
Name [3] 304619 0
CARDIHAB Pty Ltd
Address [3] 304619 0
Level 3, 315 Brunswick Street
Fortitude Valley, QLD 4006
Country [3] 304619 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304388 0
Griffith University; Griffith University Human Research Ethics Committee
Ethics committee address [1] 304388 0
Office of Research
Level 0, Bray Centre
170 Kessels Road
Griffith University Nathan, QLD 4111
Ethics committee country [1] 304388 0
Australia
Date submitted for ethics approval [1] 304388 0
26/04/2019
Approval date [1] 304388 0
21/08/2019
Ethics approval number [1] 304388 0
2019/468

Summary
Brief summary
This project will evaluate the feasibility of the use of a mobile health application (mHealth app) as an effective secondary prevention program for people in remote and rural Queensland who have experienced a cardiovascular event. This study will evaluate feasibility of methods and procedures for a large trial, using pre-defined criteria for recruitment (>80% approached recruited), retention (>80% participants complete study phases), protocol fidelity (>90% of participants receive allocated intervention for entire study). This study will provide information on the resources and management required for a larger efficacy RCT. Secondary prevention outcomes (i.e., depression, quality of life, cardiovascular clinical and lifestyle risk factors, functional capacity, & medication adherence) will be collected. Participants will be randomised to receive either standard care (nurse telephone follow-up and referral to secondary prevention program 8-12 weeks), or the mHealth program (mHealth app [includes weekly nurse mentoring] & standard care). Approximately 60 participants will be recruited to the study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96782 0
Dr Katina Corones-Watkins
Address 96782 0
Griffith University,
School of Nursing & Midwifery,
170 Kessels Road
Nathan, QLD 4111
Country 96782 0
Australia
Phone 96782 0
+61 7 3735 5406
Fax 96782 0
Email 96782 0
[email protected]
Contact person for public queries
Name 96783 0
Dr Katina Corones-Watkins
Address 96783 0
Griffith University,
School of Nursing & Midwifery,
170 Kessels Road
Nathan, QLD 4111
Country 96783 0
Australia
Phone 96783 0
+61 7 3735 5406
Fax 96783 0
Email 96783 0
[email protected]
Contact person for scientific queries
Name 96784 0
Dr Katina Corones-Watkins
Address 96784 0
Griffith University,
School of Nursing & Midwifery,
170 Kessels Road
Nathan, QLD 4111
Country 96784 0
Australia
Phone 96784 0
+61 7 3735 5406
Fax 96784 0
Email 96784 0
[email protected]

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


What supporting documents are/will be available?

No Supporting Document Provided



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.