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Trial registered on ANZCTR


Registration number
ACTRN12613000395730
Ethics application status
Not yet submitted
Date submitted
8/04/2013
Date registered
10/04/2013
Date last updated
10/04/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of an educational resource for cardiac secondary prevention: a randomised controlled trial
Scientific title
Investigating whether patients with acute coronary syndrome who receive a secondary-prevention educational resource have greater attendance at cardiac rehabilitation compared to patients who receive usual inpatient education
Secondary ID [1] 282270 0
None
Universal Trial Number (UTN)
U1111-1141-6276
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute coronary syndrome 288805 0
Condition category
Condition code
Cardiovascular 289162 289162 0 0
Coronary heart disease
Public Health 289188 289188 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An educational booklet produced by the Heart Foundation Australia titled 'My heart my life'. The resource aims to support patients with coronary heart disease to understand and better manage their cardiac condition. The booklet has 5 main topic areas: (1) My heart (explains coronary heart disease) (2) In hospital (medical tests, medications, managing emotions, preparing for discharge) (3) My recovery (GP follow-up, cardiac rehabilitation, general information on risk factors) (4) Services and support (role of cardiac rehabilitation and the heart foundation) (5) Take action (goal setting for personal risk factors including smoking, nutrition, alcohol, physical activity, weight, lipids, blood pressure, diabetes and psychological health). The resource uses diagrams, text and some interactive exercises (e.g. checklists, self-evaluation and goal setting based on the stages of change model), and is intended to be given to patients to take home and use as part of their recovery.
The intervention will be provided to patients in hospital by the research assistant who will briefly explain its contents (estimated time 15 minutes). A follow-up phone call will be made to patients at 1 month post-discharge, therefore the duration of the intervention is 1 month.
Intervention code [1] 286900 0
Treatment: Other
Intervention code [2] 286917 0
Lifestyle
Intervention code [3] 286918 0
Behaviour
Comparator / control treatment
Usual cardiac secondary prevention education provided to all patients with acute coronary syndrome in each site. This care may include access to other Heart Foundation brochures, or individualised education sessions about coronary heart disease, risk factors and discharge planning from the patient's nurse (the My Heart, my Life resource is not given as part of usual care at Eastern Health). The amount and intensity may differ between sites and may also vary according to day of the week and work-load demands. The research assistant will document any education provided to the patient as part of usual care.
If provided, education sessions are usually of 10-15 minutes duration. The follow-up period of the comparator will be 1 month following hospital discharge.
Control group
Active

Outcomes
Primary outcome [1] 289271 0
Attendance for at least one session of cardiac rehabilitation as self-reported by the patient during the 1-month phone follow-up
Timepoint [1] 289271 0
One month post-discharge from hospital
Secondary outcome [1] 302137 0
Number of cardiac-related readmissions to hospital and presentations to Emergency Departments since discharge (captured using hospital admission datasets)
Timepoint [1] 302137 0
One month post-discharge from hospital
Secondary outcome [2] 302138 0
Change in knowledge of cardiac condition and risk factors, and in self-management ability between baseline and follow-up. A questionnaire will be used to capture the patients’ understanding of acute coronary syndrome (ACS) terms and knowledge of risk factors. The ACS and risk factor knowledge questions are modified from the validated CHD Knowledge and Awareness Questionnaire (CKAQ).
This questionnaire will also use two constructs from the validated Health Education Impact Questionnaire. The first construct (health directed activity) captures participants’ level of functional activity incorporated into lifestyle. The second construct (self-monitoring and insight) captures how an individual engages in self-monitoring of their condition.
This questionnaire is estimated to take about 10 minutes to complete and will be administered by the research assistant.
Timepoint [2] 302138 0
One month post-discharge from hospital

Eligibility
Key inclusion criteria
All participants who are hospitalised within one of three Eastern Health cardiology units with a preliminary diagnosis of ACS (ICD-10 codes 120, 121, 122) will be eligible for inclusion. Participants must also be eligible for referral to a cardiac rehabilitation program; this will be determined by the cardiologist and cardiology nurse caring for that patient. Patients will be aged 18 years and over.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe cognitive impairment or mental illness, unless a carer is able to complete questionnaires on behalf of the participant.
Patients who are clinically unstable will also be excluded (eligibility to participate will be determined by the attending cardiology nurse using a check list).
Non-English speaking patients are unable to be included as the education resource and questionnaires are written in the English language only.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited by a research assistant (RA) who will visit each cardiology unit at least twice weekly, after first liaising with the Nurse Unit Manager to identify patients with a diagnosis of ACS and their eligibility to participate in the study. The RA will provide the participant information and consent form (PICF) and discuss the study with the patient before seeking consent.
Patients will be randomised to intervention or control group within each CCU. Patients will be randomised into usual care vs. intervention groups using computer generated random numbers, generated in advance and placed in numbered, sealed envelopes. After each patient has been recruited, the sequential envelope will be opened and the participant allocated to intervention or control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random numbers (simple randomisation)
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
Allowing for a 2-3 month baseline data collection period, the expected sample size would be up to 100 patients (a total of n=50 patients in each arm of the study, across the 3 sites). A total of 1459 patients with ACS attended Eastern Health from January to November 2012 therefore this sample size is achievable. Assuming a 5% significance level and 80% power, this sample size will allow for detection of a difference in rates of attendance at CR of 30% between the control and intervention groups. This difference in attendance rates is feasible. A Cochrane review from 2010 identified three randomised controlled trials to increase uptake of CR; all improved uptake in intervention compared to control groups. One study found that using motivational letters increased uptake by 29% (43), while using follow-up phone calls and home visits increased uptake by 30%

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/05/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 845 0
Box Hill Hospital - Box Hill
Recruitment hospital [2] 846 0
Angliss Hospital - Upper Ferntree Gully
Recruitment hospital [3] 847 0
Maroondah Hospital - Ringwood East

Funding & Sponsors
Funding source category [1] 287039 0
Charities/Societies/Foundations
Name [1] 287039 0
Heart Foundation Australia
Country [1] 287039 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Melbourne Burwood Campus,
221 Burwood Highway,
Burwood, VIC 3125
Country
Australia
Secondary sponsor category [1] 285817 0
None
Name [1] 285817 0
Address [1] 285817 0
Country [1] 285817 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289074 0
Eastern Health Human Research Ethics Committee
Ethics committee address [1] 289074 0
Ethics committee country [1] 289074 0
Australia
Date submitted for ethics approval [1] 289074 0
22/04/2013
Approval date [1] 289074 0
Ethics approval number [1] 289074 0

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

Contacts
Principal investigator
Name 39094 0
Dr Alison Beauchamp
Address 39094 0
Faculty of Health
Deakin University
Melbourne Burwood Campus,
221 Burwood Highway, Burwood, VIC 3125
Country 39094 0
Australia
Phone 39094 0
+61 3 92446517
Fax 39094 0
Email 39094 0
alison.beauchamp@deakin.edu.au
Contact person for public queries
Name 39095 0
Alison Beauchamp
Address 39095 0
Faculty of Health
Deakin University
Melbourne Burwood Campus,
221 Burwood Highway, Burwood, VIC 3125
Country 39095 0
Australia
Phone 39095 0
+61 3 92446517
Fax 39095 0
Email 39095 0
alison.beauchamp@deakin.edu.au
Contact person for scientific queries
Name 39096 0
Alison Beauchamp
Address 39096 0
Faculty of Health
Deakin University
Melbourne Burwood Campus,
221 Burwood Highway, Burwood, VIC 3125
Country 39096 0
Australia
Phone 39096 0
+61 3 92446517
Fax 39096 0
Email 39096 0
alison.beauchamp@deakin.edu.au

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.