Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000440628
Ethics application status
Approved
Date submitted
16/04/2014
Date registered
29/04/2014
Date last updated
23/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Perceptions about Acute Coronary Syndrome: An Intervention Study
Scientific title
A Psychoeducational, Visual Intervention with Acute Coronary Syndrome Patients to improve their illness perceptions.
Secondary ID [1] 284448 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 291669 0
Condition category
Condition code
Cardiovascular 292048 292048 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is an intervention study as half the participants will be randomized to complete a brief (10-15 minute), visual, psychoeducation intervention shown to patients on a computer tablet. The intervention will be shown to patients who are randomised to the intervention condition, after the have completed their baseline questionaire. The intervention will be personalized into one of two levels, dependent on the severity of the patients’ heart attack as estimated primarily from their troponin levels (Mild: up to 200 micrograms per litre, or moderate to severe: up to and above 2000 micrograms per litre). The patient’s troponin levels are measured in the bloods taken from patients when they are admitted to hospital. After patients are recruited for the study, their notes will be consulted to obtain their troponin peak level. This will then be used to determine whether the patient fits into the mild or moderate to severe group and which images of approximate damage they will be shown. Patients will also be shown visual representations of how the heart works, how a blood clot forms, an approximation of the damage they have received and what they can now to keep their heart healthy, including animations depicting how their medications of statin and aspirin work and other healthy behaviours.
Intervention code [1] 289201 0
Rehabilitation
Comparator / control treatment
Patients who are not randomised into the intervention condition will receive standard care as usual. For the purposes of our study, standard care as usual is the care and treatment that all patients receive while in the coronary care unit. Therefore those who are randomised into the intervention group receive the intervention which is treatment in addition to this standard care.
Control group
Active

Outcomes
Primary outcome [1] 291926 0
Illness perceptions - Illness perceptions will be measured using the Brief Illness Perception Questionnaire (Broadbent, Petrie, Main, & Weinman, 2006) as well as assessing patient's drawings of their perceptions of their heart following their acute coronary event (as used in Broadbent, Petrie, Ellis, Ying, & Gamble, 2004).
Timepoint [1] 291926 0
Post-Intervention - participants complete post-intervention assessment between 24 hours and 1 week following the completion of their baseline questionnaire.
Secondary outcome [1] 307849 0
Adherence to medication - Adherence to medication will be measured using the Medication Adherence Rating Scale (MARS; Thompson, Kulkami, & Sergejew, 2000).
Timepoint [1] 307849 0
7-week follow up
Secondary outcome [2] 307850 0
Return to work - return to work as patient's return to any work they took part in prior to their heart attack (e.g. full time, part time, volunteer work)
Timepoint [2] 307850 0
7-week follow up
Secondary outcome [3] 307863 0
Psychological distress/anxiety - Psychological distress and anxiety are measured using the Patient Health Questionnaire 9 (Kroenke, Spitzer, & Williams, 2001) and the Cardiac Anxiety Questionnaire (Eifert et al., 2000).
Timepoint [3] 307863 0
7 week follow-up

Eligibility
Key inclusion criteria
Patients will be included if they are admitted to the Auckland City Hospital Coronary Care Unit with a diagnosis of Acute Coronary Syndrome.
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 cannot speak English and are under 18 years of age.

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)
ACS patients will be recruited from the coronary care unit at Auckland City Hospital for involvement within our study. All patients who express interest in taking part in the study will then complete a baseline questionnaire. After this is completed, an envelope is opened which has been randomly allocated by someone independent to the study using a random number list, which either says that the patient is in the control or intervention condition.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation procedure used was simple randomisation using a randomisation table created by computer software. The randomisation was completed by another student who was not involved within our study. They generated a random number sequence and allocated participants to either control or intervention based on numbers being odd or even. They then placed these allocations into 70 different envelopes (one for each participant) numbered from 1 to 70. The student researcher then opens the corresponding envelope for each participant after they have completed baseline.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/04/2014
Actual
14/04/2014
Date of last participant enrolment
Anticipated
30/09/2014
Actual
24/07/2014
Date of last data collection
Anticipated
Actual
30/09/2014
Sample size
Target
70
Accrual to date
Final
71
Recruitment outside Australia
Country [1] 6012 0
New Zealand
State/province [1] 6012 0

Funding & Sponsors
Funding source category [1] 289098 0
University
Name [1] 289098 0
Masters of Health Psychology project in the Department of Psychological Medicine, Faculty of Medical and Health Sciences, at the University of Auckland, New Zealand.
Country [1] 289098 0
New Zealand
Primary sponsor type
Individual
Name
Dr Elizabeth Broadbent
Address
Department of Psychological Medicine
Faculty of Medical and Health Sciences
University of Auckland
Private Bag 92019
Auckland, 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 287759 0
None
Name [1] 287759 0
Address [1] 287759 0
Country [1] 287759 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290886 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 290886 0
Ethics committee country [1] 290886 0
New Zealand
Date submitted for ethics approval [1] 290886 0
Approval date [1] 290886 0
04/03/2014
Ethics approval number [1] 290886 0

Summary
Brief summary
Illness perceptions have been found to predict functional outcomes across many illness populations. A new method of measuring illness perceptions, patients’ drawings of their illness, has been validated as an alternative means of assessment. One patient group for whom illness perception drawings have been found to relate to outcomes such as depression and poor illness behaviours are heart patients. Heart patients have also been found to have inaccurate cardiac risk perceptions (Broadbent et al., 2006) and often their mental imagery of what is wrong with their heart is inaccurate (Broadbent et al., 2004). The proposed study will therefore investigate whether a brief, psychoeducational intervention to correct patient’s mental imagery of damage to the heart and how their medication works, can facilitate their recovery through outcomes including return to normal activity, adherence and psychological wellbeing.
This study hyothesises that the intervention will improve patients’ illness perceptions as represented through their drawings, and in turn improve their recovery as revealed in functional outcomes such as decreased return to work times and improved adherence. The possible impact of this study clinically, is that if the intervention is proven effective, it could be administered to cardiac patients to help improve their recovery and wellbeing.
Trial website
Trial related presentations / publications
Jones, A. S. K., Ellis, C. J., Nash, M., Stanfield, B., & Broadbent, E. (2015). Using animation to improve recovery from acute coronary syndrome: a randomized trial. Annals of Behavioral Medicine, 50(1), 108-118.
Public notes
Attachments [1] 36 36 0 0
/AnzctrAttachments/366178-ACS Drawing Intervention Study Research Protocol 16.04.2014.docx

Contacts
Principal investigator
Name 47770 0
Dr Elizabeth Broadbent
Address 47770 0
Department of Psychological Medicine
The University of Auckland
Private Bag 92019
Auckland 1142
Country 47770 0
New Zealand
Phone 47770 0
+64 9 373 7599; extn. 86756
Fax 47770 0
Email 47770 0
[email protected]
Contact person for public queries
Name 47771 0
Miss Annie Jones
Address 47771 0
Department of Psychological Medicine
The University of Auckland
Private Bag 92019
Auckland 1142
Country 47771 0
New Zealand
Phone 47771 0
+64 21 034 0860
Fax 47771 0
Email 47771 0
[email protected]
Contact person for scientific queries
Name 47772 0
Dr Elizabeth Broadbent
Address 47772 0
Department of Psychological Medicine
The University of Auckland
Private Bag 92019
Auckland 1142
Country 47772 0
New Zealand
Phone 47772 0
+64 9 373 7599; extn. 86756
Fax 47772 0
Email 47772 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
EmbaseUsing Animation to Improve Recovery from Acute Coronary Syndrome: A Randomized Trial.2016
N.B. These documents automatically identified may not have been verified by the study sponsor.