Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000383662
Ethics application status
Approved
Date submitted
31/03/2014
Date registered
9/04/2014
Date last updated
19/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Using Innovative Technology to Identify Postoperative Atrial Fibrillation in cardiac surgical patients after hospital discharge (iTIP)
Scientific title
Identifying postoperative Atrial Fibrillation in cardiac surgical patients after hospital discharge using an iPhone electrocardiogram (ECG)
Secondary ID [1] 284326 0
NIL
Universal Trial Number (UTN)
Trial acronym
iTIP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 291477 0
Condition category
Condition code
Cardiovascular 291842 291842 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will receive individualised education regarding atrial fibrillation (AF) and its health risks, and will be provided with education materials to take home. All consenting patients will be provided with a handheld iPhone ECG device (iECG); called the AliveCor Heart monitor which is an approved medical device (ARTG Identifier 208100). The iECG is a special cover that attaches to an iPhone, which enables a single lead ECG reading to be taken using an application on the iPhone. Patients will be taught how to record their own iECG. Patients will be asked to record an iECG four times per day for four weeks. Recordings will be spread out through the day at times suitable to the patient (e.g. Immediately before breakfast, lunch, dinner and sleep). Patients will also be advised to take additional iECG recordings, as soon as practicable, if they experience AF symptoms. Each iECG will be automatically transmitted to a secure server where each iECG will be analysed by the automated algorithm. iECGs will be monitored and reviewed by the research assistant for the presence of AF and also to ensure that patients are performing their ECG recordings. If AF, or any other clinically significant event is identified, the research assistant will contact the patient and advise them to arrange for urgent follow-up with their treating doctors, and will advise the treating doctor and specialists of the findings.

Patients will also be asked to keep an AF symptom recurrence checklist for 4 weeks. They will be asked to self-report on the occurrence of AF, AF-related symptoms including palpitations, dizziness and syncope, and any medical or hospital presentation related to these.
Intervention code [1] 289043 0
Early detection / Screening
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291757 0
The feasibility of patient self-monitoring for AF recurrence using an iECG. This will be assessed using a combination of measures including:
* The ability of the iECG to identify recurrences of AF; measured using data from each participant obtained from the iECG - reviewed for the presence of AF by the research assistant and the automated algorithm
* The compliance of participants to the intervention; measured by the number of iECG recordings they record over the one month - i.e are they achieving the requested target of 3-4 recordings each day
* Qualitative data on process measures and barriers; measured using semi-structured participant interviews at one month post discharge from hospital
* Acceptability and patient willingness to participate in the program; measured using recruitment data including the reasons provided for non-participation
Timepoint [1] 291757 0
At completion of the study, i.e. when all participants have completed the intervention.
Secondary outcome [1] 307434 0
The proportion of patients identified with recurrent AF (identified using the self-administered single-lead iPhone ECG [AliveCor Heart monitor])
Timepoint [1] 307434 0
4 weeks post initial assessment
Secondary outcome [2] 307435 0
Estimation of stroke risk of the participants identified with recurrent AF (using CHA2DS2VASc score)
Timepoint [2] 307435 0
4 weeks post initial assessment
Secondary outcome [3] 307436 0
Qualitative data regarding acceptability of patient use of the handheld iPhone ECG (AliveCor Heart monitor). This will be measured using semi-structured interviews with participants using open-ended questions.
Timepoint [3] 307436 0
4 weeks post initial assessment
Secondary outcome [4] 310711 0
Patient knowledge of AF as measured with a modified version of the Atrial Fibrillation Knowledge questionnaire.
Timepoint [4] 310711 0
4 weeks post initial assessment

Eligibility
Key inclusion criteria
Age over 18 years, who have experienced postoperative AF following cardiac surgery and have reverted or been cardioverted back to sinus rhythm prior to discharge, and who have additional AF risk factors (eg. aged greater than or equal to 65 years, valve surgery, heart failure, or hypertension).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they are non-English speaking, have insufficient cognitive capacity for the consent and interview process, are not returning home (transferred to rehabilitation service), or do not have a telephone

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be recruited from the cardiothoracic ward by the research assistant in consultation with the ward staff. The research assistant will screen the patients for eligibility between day 3 and 4 postoperatively, approach them to discuss participation, and gain informed consent. All participants will be allocated to the intervention as there is no control group and no randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Descriptive statistics will be used to summarise sociodemographic data, CHA2DS2VASc and the incidence of postoperative complications (Major Adverse Cardiovascular Events [MACE]) and atrial fibrillation using frequencies and percentages, means and standard deviations according to the level of the data. Patient’s knowledge level will be compared pre and post the intervention using paired t-tests.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/03/2014
Actual
1/04/2014
Date of last participant enrolment
Anticipated
28/04/2015
Actual
16/06/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
44
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2230 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 3034 0
North Shore Private Hospital - St Leonards
Recruitment postcode(s) [1] 7911 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 288962 0
University
Name [1] 288962 0
University of Sydney
Country [1] 288962 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
City Rd, Darlington NSW 2008
Country
Australia
Secondary sponsor category [1] 287643 0
None
Name [1] 287643 0
Address [1] 287643 0
Country [1] 287643 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290772 0
Northern Sydney Local Health District HREC
Ethics committee address [1] 290772 0
Research Office, Kolling Building, Level 13
Royal North Shore Hospital
St Leonards, NSW, 2065
Ethics committee country [1] 290772 0
Australia
Date submitted for ethics approval [1] 290772 0
Approval date [1] 290772 0
03/02/2014
Ethics approval number [1] 290772 0
HREC/13/HAWKE/415
Ethics committee name [2] 291744 0
North Shore Private Hospital Ethics Committee
Ethics committee address [2] 291744 0
North Shore Private Hospital
3 Westbourne Street
St Leonards, NSW, 2065
Ethics committee country [2] 291744 0
Australia
Date submitted for ethics approval [2] 291744 0
11/03/2014
Approval date [2] 291744 0
17/07/2014
Ethics approval number [2] 291744 0
NSPHEC 2014-006

Summary
Brief summary
AF is a major health and economic burden. Post-operative AF is thought to be mainly transient and reversible, however, there is very limited information about how often it may recur. Some research suggests it affects up to 8% of patients in the two years following surgery, but this is likely an under-estimate of the actual rate, as AF is often asymptomatic and there is no routine surveillance. The rationale for this study is to determine if a brief intervention increases knowledge about AF symptoms and whether a simple iPhone based handheld ECG device could be utilised to identify AF when recordings are obtained by post-operative cardiothoracic surgical patients.
Trial website
Trial related presentations / publications
The results of this study were presented at the European Association of Cardio-Thoracic Surgeons annual conference, Amsterdam, October 2015:
Self-monitoring for atrial fibrillation recurrence in the discharge period post-cardiac surgery using an iPhone electrocardiogram. Nicole Lowres, Georgina Mulcahy, Robyn Gallagher, S Ben Freedman, David Marshman, Ann Kirkness, Jessica Orchard, Lis Neubeck. (Abstracts were not published by the conference)
Public notes

Contacts
Principal investigator
Name 47222 0
Ms Nicole Lowres
Address 47222 0
Anzac Research Institute, University of Sydney
Hospital Rd, Concord, 2139, NSW
Country 47222 0
Australia
Phone 47222 0
+61 4 07256613
Fax 47222 0
Email 47222 0
[email protected]
Contact person for public queries
Name 47223 0
Prof Robyn Gallagher
Address 47223 0
Charles Perkins Centre, Sydney Nursing School
Room 2210, Level 2, Building D17
The University of Sydney
Camperdown NSW 2008
Country 47223 0
Australia
Phone 47223 0
+61 2 9036 0000
Fax 47223 0
Email 47223 0
[email protected]
Contact person for scientific queries
Name 47224 0
Dr Lis Neubeck
Address 47224 0
Charles Perkins Centre, Sydney Nursing School
Level 2, Building D17
The University of Sydney
Camperdown NSW 2008
Country 47224 0
Australia
Phone 47224 0
+61 4 17015282
Fax 47224 0
Email 47224 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseIdentifying postoperative atrial fibrillation in cardiac surgical patients posthospital discharge, using iPhone ECG: A study protocol.2015https://dx.doi.org/10.1136/bmjopen-2014-006849
EmbaseSelf-monitoring for atrial fibrillation recurrence in the discharge period post-cardiac surgery using an iPhone electrocardiogram.2016https://dx.doi.org/10.1093/ejcts/ezv486
N.B. These documents automatically identified may not have been verified by the study sponsor.