ANZCTR - Registration

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12617000019303

Ethics application status

Approved

Date submitted

20/12/2016

Date registered

5/01/2017

Date last updated

5/01/2017

Type of registration

Retrospectively registered

Titles & IDs

Public title

Basic life support training for patients and their family members at cardiac rehabilitation: a feasibility study.

Scientific title

Basic life support training for patients and their family members at cardiac rehabilitation: a feasibility study.

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

acute myocardial infarction

post cardiac surgery

Condition category

Condition code

Cardiovascular

Coronary heart disease

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

All participants will complete a one off, face-to-face group training session in cardiopulmonary resuscitation (CPR) using a self-instructional video (SIV) training kit which includes: a reusable, inflatable manikin and an instructional DVD. This will be run as part of the education sessions offered in the cardiac rehabilitation program.
- the training component, using the SIV kit runs for around 30 minutes
- post training research assessments (paper based survey, skill assessment) will then be conducted
- all participants will be given a SIV kit to use, which they can then take home to share with others
- the training session will be facilitated by one of the study investigators (SC) who is also a cardiac nurse and trained CPR instructor

Participants will be contacted one month post training via telephone to assess if they have used the kit once at home to a) review the training themselves or b) share the kit and train others

Intervention code [1]

Rehabilitation

Intervention code [2]

Behaviour

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

The primary outcome is to assess willingness of cardiac patients and their family members to participate in CPR training at cardiac rehabilitation sessions. This will be measured by attendance of patients and family members at the scheduled CPR training sessions.

Timepoint [1]

Training- attendance will be collected.

Secondary outcome [1]

Willingness to use CPR skills (measured at all time points on 5 point Likert scales)

Timepoint [1]

- pre-training
-post-training
-one-month post-training

Secondary outcome [2]

psychological distress measured by the Kessler 10L3D

Timepoint [2]

- post training
- one month post training

Secondary outcome [3]

Skills assessment- measured on skill reporting manikin

Timepoint [3]

- one month post training

Secondary outcome [4]

Number of times SIV CPR kit shared by participants

Timepoint [4]

- one month post training, via telephone follow up and completing paper based survey

Secondary outcome [5]

Staff feedback on training

Timepoint [5]

At the completion of participant enrollment via paper based survey

Secondary outcome [6]

Confidence to use CPR skills (measured at all time points on 5 point Likert scales)

Timepoint [6]

- pre-training
-post-training
-one-month post-training

Eligibility

Key inclusion criteria

Patients: Enrolled in the cardiac rehabilitation program; aged >18 years; fluent in English; competent to provide consent; medically stable.
Family: relative enrolled in cardiac rehabilitation program; lives at home permanently with relative; aged >18 years; fluent in English; competent to provide consent.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Unable to physically participate (ie. knee or back injuries)

Study design

Purpose of the study

Educational / counselling / training

Allocation to intervention

Non-randomised 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)

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

Efficacy

Statistical methods / analysis

Categorical variables will be described using proportions and compared using the chi-squared statistic. Continuous variables will be presented as mean with standard deviation or median with interquartile range as appropriate. When comparing a continuous outcome over three study time points the Friedman test will be used. Post-hoc testing will then conducted using the Wilcoxon Signed Rank Test to assess at which time points the significant differences occurred. Effect size was calculated using z scores and dividing z by the square root of the number of cases. Statistical analyses will be performed with SPSS v24 (Armonk, NY: IBM corp) and p values <0.05 will be considered statistically significant.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

2/05/2016

Date of last participant enrolment

Anticipated

Actual

14/07/2016

Date of last data collection

Anticipated

Actual

24/08/2016

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Cabrini Hospital - Malvern - Malvern

Recruitment postcode(s) [1]

3144 - Malvern

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

GPO Box 1421 Canberra ACT 2601

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

Laerdal Australia

Address [2]

Laerdal Pty Ltd
PO Box 52
OAKLEIGH VIC 3166

Country [2]

Australia

Primary sponsor type

University

Name

Aus-ROC, Monash Universtiy

Address

School of Public Health and Preventive Medicine
Level 6, 99 Commercial Road
Melbourne, 3004
Victoria

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Cabrini Human Research Ethics Committee

Ethics committee address [1]

Cabrini Institute
183 Wattletree Road
Malvern, 3144
Victoria

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

16/03/2016

Approval date [1]

20/04/2016

Ethics approval number [1]

02-02-05-16

Summary

Brief summary

A cardiac arrest is a life threatening condition that occurs when a victims’ heart stops suddenly and breathing becomes abnormal. To prevent death,  someone nearby must start basic life support (BLS) measures. This includes; 1) recognising the person is in cardiac arrest, 2) calling for help and 3) commencing cardiopulmonary resuscitation (CPR). CPR involves compressing the chest, and if able and willing, providing mouth to mouth breaths. 

Up to 75% of cardiac arrests will happen in the home environment and nearly half of these will be witnessed by someone at home. This person is usually the spouse or a family member of the victim.   Therefore it is important that family members of people who are more at risk of having a cardiac arrest are trained in BLS skills.

People who have had a prior heart attack, or other heart conditions are at higher risk of repeat events, including the risk of having a cardiac arrest. Therefore the relatives of these people should be targeted for BLS training. 

Approximately four to six weeks after hospitalisation for a heart attack or cardiac event, most patients attend cardiac rehabilitation. Cardiac rehabilitation is a six to eight week outpatient program, usually run at a hospital by trained cardiac rehabilitation nurses and other health staff. These programs include both exercise and education sessions. Family members are encouraged to attend the education sessions along with the patients. Cardiac rehabilitation programs may provide the ideal catchment and environment to provide BLS training to both cardiac patients and their family members.

In recent years, the way we teach and perform BLS has changed significantly. BLS training can now be undertaken in 30 minutes and without a formal instructor. This  training can be done via a self-training kit that includes a training video and a reusable, inflatable manikin to practice CPR skills. The most important part of CPR is the chest compressions, with the mouth to mouth being optional. Therefore learning and performing BLS is much easier than it used to be.  

In this study we will train patients and family members attending the Cabrini cardiac rehabilitation program using self-instructional BLS video training kits. The primary aim of this research is to assess whether it is feasible to conduct BLS training to patients and their family members at a cardiac rehabilitation program. Our secondary objectives are: 1) to assess whether this group can perform BLS adequately; 2) to assess willingness to utilise and maintain BLS skills; 3) to determine the level of secondary training (sharing of training kit) that is undertaken by participants; 4) to assess levels of anxiety and confidence pre and post training. In order to assess the feasibility of running the program at cardic rehabilitation, cardiac rehabilitation staff will complete a brief survey at the completion of the study.

Trial website

Trial related presentations / publications

Presentations:
- European Resuscitation Council, Young Investigators Presentation, Iceland, Sept 2016
- Victorian Cardiac Rehabilitation Association, Professional Development Day, Melbourne, Oct 2016

Public notes

Contacts

Principal investigator

Name

Dr Dion Stub

Address

Cabrini Hospital Malvern
198 Wattletree Road
Malvern, 3144
Victoria

Country

Australia

Phone

+61 3 9508 1222

Fax

[email protected]

Contact person for public queries

Name

Susie Cartledge

Address

Monash University
Alfred Centre
Level 6, 99 Commercial Road
Melbourne, 3004
Victoria

Country

Australia

Phone

+61 3 99030244

Fax

[email protected]

Contact person for scientific queries

Name

Susie Cartledge

Address

Monash University
Alfred Centre
Level 6, 99 Commercial Road
Melbourne, 3004
Victoria

Country

Australia

Phone

+61399030244

Fax

[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

No additional documents have been identified.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically