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A mobile health application for people in remote and rural Queensland who have experienced a cardiovascular event.

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.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001229864
Enrollment
60
Registered
2021-09-13
Start date
2021-10-04
Completion date
Unknown
Last updated
2021-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 secon

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.

Sponsors

Menzies Health Institute Queensland (MHIQ)
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026