Trial Review

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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] 290604 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute myocardial infarction 301087 0
post cardiac surgery 301088 0
Condition category
Condition code
Cardiovascular 300859 300859 0 0
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] 296636 0
Rehabilitation
Intervention code [2] 296637 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300489 0
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] 300489 0
Training- attendance will be collected.
Secondary outcome [1] 330082 0
Willingness to use CPR skills (measured at all time points on 5 point Likert scales)
Timepoint [1] 330082 0
- pre-training
-post-training
-one-month post-training
Secondary outcome [2] 330084 0
psychological distress measured by the Kessler 10L3D
Timepoint [2] 330084 0
- post training
- one month post training
Secondary outcome [3] 330085 0
Skills assessment- measured on skill reporting manikin
Timepoint [3] 330085 0
- one month post training
Secondary outcome [4] 330086 0
Number of times SIV CPR kit shared by participants
Timepoint [4] 330086 0
- one month post training, via telephone follow up and completing paper based survey
Secondary outcome [5] 330087 0
Staff feedback on training
Timepoint [5] 330087 0
At the completion of participant enrollment via paper based survey
Secondary outcome [6] 330465 0
Confidence to use CPR skills (measured at all time points on 5 point Likert scales)
Timepoint [6] 330465 0
- 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
50
Accrual to date
Final
83
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7108 0
Cabrini Hospital - Malvern - Malvern
Recruitment postcode(s) [1] 14866 0
3144 - Malvern

Funding & Sponsors
Funding source category [1] 295164 0
Government body
Name [1] 295164 0
National Health and Medical Research Council
Country [1] 295164 0
Australia
Funding source category [2] 295203 0
Commercial sector/Industry
Name [2] 295203 0
Laerdal Australia
Country [2] 295203 0
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] 294036 0
None
Name [1] 294036 0
Address [1] 294036 0
Country [1] 294036 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296513 0
Cabrini Human Research Ethics Committee
Ethics committee address [1] 296513 0
Cabrini Institute
183 Wattletree Road
Malvern, 3144
Victoria
Ethics committee country [1] 296513 0
Australia
Date submitted for ethics approval [1] 296513 0
16/03/2016
Approval date [1] 296513 0
20/04/2016
Ethics approval number [1] 296513 0
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 70690 0
Dr Dion Stub
Address 70690 0
Cabrini Hospital Malvern
198 Wattletree Road
Malvern, 3144
Victoria
Country 70690 0
Australia
Phone 70690 0
+61 3 9508 1222
Fax 70690 0
Email 70690 0
dion@dionstub.com
Contact person for public queries
Name 70691 0
Ms Susie Cartledge
Address 70691 0
Monash University
Alfred Centre
Level 6, 99 Commercial Road
Melbourne, 3004
Victoria
Country 70691 0
Australia
Phone 70691 0
+61 3 99030244
Fax 70691 0
Email 70691 0
susie.cartledge@monash.edu
Contact person for scientific queries
Name 70692 0
Ms Susie Cartledge
Address 70692 0
Monash University
Alfred Centre
Level 6, 99 Commercial Road
Melbourne, 3004
Victoria
Country 70692 0
Australia
Phone 70692 0
+61399030244
Fax 70692 0
Email 70692 0
susie.cartledge@monash.edu

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

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