Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000082808
Ethics application status
Approved
Date submitted
23/11/2020
Date registered
1/02/2021
Date last updated
1/02/2021
Date data sharing statement initially provided
1/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of an mHealth self-help intervention on readmission rates after adult cardiac surgery: a pilot randomised controlled trial.
Scientific title
Impact of an mHealth self-help intervention on readmission rates after adult cardiac surgery: a pilot randomised controlled trial
Secondary ID [1] 302851 0
Nil known
Universal Trial Number (UTN)
U1111-1261-6616
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiac surgery 319831 0
Condition category
Condition code
Cardiovascular 317773 317773 0 0
Coronary heart disease
Surgery 317774 317774 0 0
Other surgery
Cardiovascular 318088 318088 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
GoShare (the intervention) is a customised care bundle that promotes self-efficacy and self-management behaviours to empower patients to have a more active role in their healthcare.
The care bundle contains a patient narrative library with a series of videos describing patient and carer experiences, in addition to links to reputable on-line resources. The content in the Cardiac Surgery bundle is customised to support adult patients undergoing cardiac surgery that requires a surgical incision on the thorax; either median sternotomy or minimally invasive access via thoracotomy. This bundle provides resources specific to receiving a diagnosis that requires cardiac surgical intervention (5 minutes, 48 seconds), preparing for heart surgery (4 minutes 47 seconds), recovery after heart surgery (5 minutes) and rehabilitation after heart surgery (2 minutes, 37 seconds). The videos are delivered by a mixture of male and female patients representing young to older adults. The patients in the videos do not discuss specifics of surgery or medical management, the focus is on strategies for self-help and self-efficacy in managing the cardiac surgical experience. The information sheets in the bundle link to the Australian Centre for Heart Health, the National Heart Foundation (NHF) and the NHF 'My Heart, My Life' application. The care bundle will be accessible to participants indefinitely.
Adult patients randomised to the intervention will receive a text-message or email link to the online platform prior to undergoing cardiac surgery with a single reminder within 48 hours of discharge from hospital. Usage metrics will be extracted from the GoShare interface to confirm access reminders, assess access frequency, assess access duration and review content items viewed at the time of access. Follow-up phone calls from an expert cardiothoracic nurse will occur at 30, 60 and 90-days after the day of surgery. Each phone call will take approximately 15 to 20 minutes. During the phone call a series of questions will be asked to confirm consent to participate, to confirm whether representation or readmission to hospital has been required, to assess quality of life (EQ5D-5L) and to assess patient activation (PAM).
Intervention code [1] 319133 0
Behaviour
Intervention code [2] 319365 0
Rehabilitation
Comparator / control treatment
The control group will receive usual pre and postoperative care that includes a preoperative phone consultation, attendance at pre-admission clinic for screening and physical assessment, written materials on discharge from hospital and a 30-day follow up phone call.
Written materials are site specific materials that are readily available to all patients.
Control group
Active

Outcomes
Primary outcome [1] 325798 0
All patients will be asked at the 30-day follow-up phone call if they have represented to hospital. Patients in the intervention group will be asked the same questions at the 60 and 90-day follow-up phone calls. All patients will have representation confirmed via cross validation with two sources; the Australian and new Zealand Society of Cardiothoracic Surgery Clinical Quality Registry and the Victorian Agency for Health Information (VAHI).
Timepoint [1] 325798 0
30-days, 60-days, 90-days and 12-months after surgery
Primary outcome [2] 325799 0
All patients will be asked at the 30-day follow-up phone call if they have required readmission to hospital. Patients in the intervention group will be asked the same questions at the 60 and 90-day follow-up phone calls. All patients will have readmission confirmed via cross validation with two sources; the Australian and new Zealand Society of Cardiothoracic Surgery Clinical Quality Registry and the Victorian Agency for Health Information (VAHI).
Timepoint [2] 325799 0
30-days, 60-days, 90-days and 12 months after surgery
Secondary outcome [1] 389176 0
Care bundle uptake will be determined by reviewing access metrics.
Timepoint [1] 389176 0
Within 12-months after surgery
Secondary outcome [2] 389177 0
Knowledge, skill and confidence for self-management as measured by the 13-item PAM (Patient Activation Measure)
Timepoint [2] 389177 0
30-days, 60-days, 90-days after surgery
Secondary outcome [3] 389178 0
Health related quality of life as measured by the EQ5D-5L.
Timepoint [3] 389178 0
30-days, 60-days and 90-days after surgery

Eligibility
Key inclusion criteria
Adults (> 18 years of age) undergoing elective CABGS, Valve surgery, CABGS and Valve surgery or aortic surgery, discharged home within 30-days, able to understand spoken English and own and use a smartphone.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Adults undergoing thoracic, transplant or non-elective surgery, not discharged within 30-days and unable to communicate in English without an interpreter.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involves contacting the holder of the allocation schedule who is off site.
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 administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In the Australian context readmission occurs in up to 15% of cardiac surgical patients, with a mean age of 64.4 years, within 30-days of surgery.
To be 95% confident that the readmission rate is within 10%, assuming 15% of the population will be readmitted a total sample size of 49 patients is required.
Frequency of representation, readmission and GoShare metrics will be reported as proportions and the EQ5D-5L and PAM endpoints are scale measures that will also be compared between intervention and control groups. Categorical variables will be analysed using chi-square or two-tailed Fisher’s exact test with appropriate degrees of freedom to test for equality of proportions. Independent samples t-tests (two-tailed) will be used to test for equality of means of continuous variables or the non-parametric equivalent Kruskal-Wallis test. The approach to analysis of repeated measures results from the EQ5D-5L and PAM will be dependent on loss to follow-up and normality of distribution.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2021
Actual
Date of last participant enrolment
Anticipated
26/11/2021
Actual
Date of last data collection
Anticipated
26/11/2022
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 18078 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 18079 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 18080 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 32066 0
3050 - Parkville
Recruitment postcode(s) [2] 32067 0
2170 - Liverpool
Recruitment postcode(s) [3] 32068 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 307271 0
University
Name [1] 307271 0
Western Sydney University
Country [1] 307271 0
Australia
Funding source category [2] 307272 0
Hospital
Name [2] 307272 0
The Royal Melbourne Hospital
Country [2] 307272 0
Australia
Primary sponsor type
Hospital
Name
The Royal Melbourne Hospital
Address
300 Grattan Street, Parkville, VIC 3010
Country
Australia
Secondary sponsor category [1] 307895 0
University
Name [1] 307895 0
Western Sydney University
Address [1] 307895 0
161-169 Macquarie St, Parramatta NSW 2150
Country [1] 307895 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307368 0
Melbourne Health HREC
Ethics committee address [1] 307368 0
300 Grattan Street, Parkville, VIC 3010
Ethics committee country [1] 307368 0
Australia
Date submitted for ethics approval [1] 307368 0
27/10/2020
Approval date [1] 307368 0
17/11/2020
Ethics approval number [1] 307368 0
HREC/69278/MH-2020

Summary
Brief summary
Patients requiring cardiac surgery during COVID-19 are at greater risk of death and adverse events. Smartphone based support could help to improve outcomes during this pandemic. Health services have been drastically reduced; preadmission clinics are limited or closed, telehealth services are inadequate, elective cardiac surgery is restricted, hospitals are limiting visitors and almost 50% of cardiac rehabilitation services have ceased. Evidence for strategies that optimise post cardiac surgery recovery is sparse. In this study the effect of a GoShare mHealth (smartphone) intervention on recovery after adult cardiac surgery during COVID-19 will be evaluated. Interventions using smartphone technology have proven effectiveness for a range of cardiovascular conditions under normal conditions. COVID-19 has created extraordinary circumstances that will persist for some time. We hypothesise that the GoShare mHealth intervention will improve (intermediate and ongoing) patient recoveryafter cardiac surgery, reducing representation and readmission rates when compared to usual care during COVID-19. This study provides an opportunity to improve patient outcome and experience for adults undergoing cardiac surgery throughout and beyond the COVID-19 pandemic in Australia. This study aims to reduce representation and readmission, by empowering patients as end-users with strategies for self-help.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106986 0
Prof Rochelle Wynne
Address 106986 0
Western Sydney Nursing & Midwifery Research Centre
Blacktown Hospital Clinical School
Marcel Crescent
Blacktown NSW 2148
Country 106986 0
Australia
Phone 106986 0
+61 407822988
Fax 106986 0
Email 106986 0
[email protected]
Contact person for public queries
Name 106987 0
Prof Rochelle Wynne
Address 106987 0
Western Sydney Nursing & Midwifery Research Centre
Blacktown Hospital Clinical School
Marcel Crescent
Blacktown NSW 2148
Country 106987 0
Australia
Phone 106987 0
+61 407822988
Fax 106987 0
Email 106987 0
[email protected]
Contact person for scientific queries
Name 106988 0
Prof Rochelle Wynne
Address 106988 0
Western Sydney Nursing & Midwifery Research Centre
Blacktown Hospital Clinical School
Marcel Crescent
Blacktown NSW 2148
Country 106988 0
Australia
Phone 106988 0
+61 407822988
Fax 106988 0
Email 106988 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
Ethical approval has not been provided to enable public sharing of participant data.


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
SourceTitleYear of PublicationDOI
EmbaseEffect of an mHealth self-help intervention on readmission after adult cardiac surgery: Protocol for a pilot randomized controlled trial.2022https://dx.doi.org/10.1111/jan.15104
N.B. These documents automatically identified may not have been verified by the study sponsor.