Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000860965
Ethics application status
Approved
Date submitted
21/08/2020
Date registered
28/08/2020
Date last updated
28/08/2020
Date data sharing statement initially provided
28/08/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A research study to determine the effect of a smartphone application (app) on management of patients with heart failure in isolation due to COVID-19
Scientific title
A randomised controlled trial on the effect of a smart device enabled monitoring system on management of heart failure among patients with pre-existing left ventricular dysfunction during COVID-19 isolation
Secondary ID [1] 302082 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 318690 0
COVID-19 318808 0
Condition category
Condition code
Cardiovascular 316702 316702 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this study, participants will be randomly allocated to use of a smartphone application (app) in addition to standard care, or standard care alone, to manage their pre-existing heart condition.

The smartphone app gives patients an effective method of capturing data such as blood pressure readings, medication adherence, task completion (e.g. exercise and rehabilitation programs) stress, blood pressure and heart rate, steps, goals, and other Patient Reported Outcomes Measures. The smartphone app has been used to support cardiac rehabilitation previously, and has been scientifically validated to match or exceed outcomes of traditional cardiac rehabilitation.

The smartphone app will require participants to enter data in the smartphone app, which will be reviewed via a secure cloud-based portal by the participant's clinician. This provides the opportunity for clinicians to monitor the participant's health status remotely and prescribe timely intervention via telephone consultation or a request to attend an in-person clinic visit if required. A task schedule for data entry will be customised by the research personnel for each participant based on the patient's clinical scenario and the Danish Heart Failure Registry. Data entry and task compliance will be reviewed weekly by the research staff via the online clinician portal.

Participants will be trained in how to use the smartphone app by research nurses. This will be performed at study entry after participants provide informed consent and will take approximately 30 minutes.

The maximum frequency of data entry (for participants with severe symptoms) will be daily and take approximately 5 minutes. The total duration of participation will be 12 months.
Intervention code [1] 318380 0
Treatment: Devices
Comparator / control treatment
Participants who are randomly allocated to the control group will continue to receive routine care for their condition. Routine care is is defined as the same care that the participant was receiving for their condition prior to entering the study - this may involve face-to-face clinical appointments or telehealth appointments, which may be conducted by the participant's GP or cardiac specialist.
Control group
Active

Outcomes
Primary outcome [1] 324836 0
Primary – composite endpoint of number of patients with either:
- Death
- Admission for heart failure
- Worsening symptoms of heart failure
- Escalation of heart failure therapy

These will be assessed via review of data entered into app and medical records.
Timepoint [1] 324836 0
Assessed only at 12 months post-intervention commencement
Secondary outcome [1] 385895 0
Admission for heart failure assessed via data entered into app and medical records.
Timepoint [1] 385895 0
Assessed only at 12 months post-intervention commencement
Secondary outcome [2] 386242 0
Worsening level of heart failure symptoms assessed via data entered into app and medical records.
Timepoint [2] 386242 0
Assessed only at 12 months post-intervention commencement
Secondary outcome [3] 386243 0
Escalation of therapy for heart failure assessed via data entered into app and medical records.
Timepoint [3] 386243 0
Assessed only at 12 months post-intervention commencement
Secondary outcome [4] 386244 0
Quality of life score assessed via EQ-5D-5L
Timepoint [4] 386244 0
Assessed only at 12 months post-intervention commencement
Secondary outcome [5] 386245 0
Mental Health Status assessed via Kessler Psychological Distress Scale (K10) and Depression, Anxiety and Stress Scale - 21 Items (DASS-21)
Timepoint [5] 386245 0
Assessed only at 12 months post-intervention commencement
Secondary outcome [6] 386246 0
Activity levels assessed via data entered into app, medical records and pedometer (built into app)
Timepoint [6] 386246 0
Assessed only at 12 months post-intervention commencement
Secondary outcome [7] 386247 0
Weight assessed via data entered into app and medical records
Timepoint [7] 386247 0
Assessed only at 12 months post-intervention commencement

Eligibility
Key inclusion criteria
1. Aged 18 years and over at the time of consent
2. Left Ventricular (LV) Dysfunction or heart failure, defined as:
a. Reduced LV function on echocardiography – either current or previous which has normalised on therapy
b. Prior symptomatic heart failure events including preserved LV function
3. Technical skills to use smart device, as assessed by a standard screening tool
4. Appropriate smart device
5. Informed consent to participate
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Other terminal disease
2. Impaired cognitive function that precludes regular use of the app system
3. Planned transfer of care to a different geographical location

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 306504 0
Other
Name [1] 306504 0
Wesley Medical Research
Country [1] 306504 0
Australia
Primary sponsor type
Other
Name
Wesley Medical Research
Address
Level 8, East Wing, The Wesley Hospital
451 Coronation Drive
Auchenflower, Queensland, 4066
Country
Australia
Secondary sponsor category [1] 307029 0
None
Name [1] 307029 0
No secondary sponsor
Address [1] 307029 0
No secondary sponsor
Country [1] 307029 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306706 0
UnitingCare Health Human Research Ethics Committee
Ethics committee address [1] 306706 0
Ethics committee country [1] 306706 0
Australia
Date submitted for ethics approval [1] 306706 0
23/06/2020
Approval date [1] 306706 0
21/08/2020
Ethics approval number [1] 306706 0

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

Contacts
Principal investigator
Name 104738 0
Dr John Rivers
Address 104738 0
Queensland Cardiovascular Group
St Andrew's Specialist Centre
St Andrew's Hospital, Level 8, 457 Wickham Terrace
Spring Hill, QLD 4004
Country 104738 0
Australia
Phone 104738 0
+61 7 3016 1111
Fax 104738 0
Email 104738 0
[email protected]
Contact person for public queries
Name 104739 0
John Rivers
Address 104739 0
Queensland Cardiovascular Group
St Andrew's Specialist Centre
St Andrew's Hospital, Level 8, 457 Wickham Terrace
Spring Hill, QLD 4004
Country 104739 0
Australia
Phone 104739 0
+61 7 3016 1111
Fax 104739 0
Email 104739 0
[email protected]
Contact person for scientific queries
Name 104740 0
John Rivers
Address 104740 0
Queensland Cardiovascular Group
St Andrew's Specialist Centre
St Andrew's Hospital, Level 8, 457 Wickham Terrace
Spring Hill, QLD 4004
Country 104740 0
Australia
Phone 104740 0
+61 7 3016 1111
Fax 104740 0
Email 104740 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.