Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000764831
Ethics application status
Approved
Date submitted
17/07/2012
Date registered
18/07/2012
Date last updated
11/02/2021
Date data sharing statement initially provided
11/02/2021
Date results information initially provided
11/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Meeting Heart Failure Patients needs for self-care education with a multi-media educational intervention: The Self-Care Educational Intervention study
Scientific title
The effect of a self-care education multi-media intervention on unplanned hospital re-admissions in heart failure patients
Secondary ID [1] 280867 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 286936 0
Condition category
Condition code
Cardiovascular 287268 287268 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Targeted education with a multi-media intervention:
Participants will particpate in a targeted educational assessment and a multi-media intervention. The session will be a one-on-one targeted education session conducted over one hour by a Heart Failure Nurse. The session will include targeted educational information and the patient will watch the 25 minute DVD. The patient will also receive a copy of the DVD and a self-care manual to take home to support their ongoing education. Topics covered will include all about heart failure, symptoms, self-care and monitoring, medicines, diet, physical activity.
Intervention code [1] 285286 0
Treatment: Other
Intervention code [2] 285296 0
Lifestyle
Intervention code [3] 285297 0
Behaviour
Comparator / control treatment
Standard treatment: participants randomised to standard care will receive standard education from the Heart Failure team of Health Care Professionals as well as written information such as phamphlets and booklets.
Control group
Active

Outcomes
Primary outcome [1] 287546 0
Unplanned re-admissions to hospital for heart failure. This information will be obtained from the patients and their medical records.
Timepoint [1] 287546 0
At 3 months and 12 months after randomisation
Secondary outcome [1] 298350 0
Knowledge of heart failure. This will be assessed with the Dutch Heart Failure Knowledge Scale (DHFKS).
Timepoint [1] 298350 0
At 3 months and 12 months after randomisation.
Secondary outcome [2] 298365 0
Self-care health related behaviours: This will be assessed with the Self-Care of Heart Failure Index(SCHFI) v6.2.
Timepoint [2] 298365 0
At 3 months and 12 months post randomisation

Eligibility
Key inclusion criteria
Accepted into Heart Failure Service at Princess Alexandra Hospital
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to read and write English
Unable to view DVD
Significant cognitive impairment
Living in a nursing home or dependent housing
Being considered for transplantation or artifical heart device
Terminal malignancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/07/2012
Actual
20/07/2012
Date of last participant enrolment
Anticipated
Actual
27/03/2015
Date of last data collection
Anticipated
Actual
30/04/2016
Sample size
Target
200
Accrual to date
Final
200
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 285650 0
Charities/Societies/Foundations
Name [1] 285650 0
Princess Alexandra Research Foundation
Country [1] 285650 0
Australia
Primary sponsor type
Individual
Name
Mary Boyde
Address
Cardiology
Princess Alexandra Hospital
Ipswich Road
Woolloongabba
Brisbane 4102
QLD
Country
Australia
Secondary sponsor category [1] 284486 0
None
Name [1] 284486 0
Address [1] 284486 0
Country [1] 284486 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287642 0
Metro South HREC
Ethics committee address [1] 287642 0
Princess Alexandra Hospital
Ipswich Road
Woolloongabba
Brisbane 4102
QLD
Ethics committee country [1] 287642 0
Australia
Date submitted for ethics approval [1] 287642 0
Approval date [1] 287642 0
08/03/2012
Ethics approval number [1] 287642 0
HREC/12/QPAH/020

Summary
Brief summary
The aim of this study is to determine the effectiveness of a multi-media educational intervention for heart failure patients in reducing unplanned hospital admissions. Associated with this outcome, the study also aims to investigate whether patients who participate in this educational intervention demonstrate improvement in their knowledge and self-care abilities.
Trial website
Trial related presentations / publications
Boyde, M., Peters, R., Hwang, R., Korczyk, D., Ha, T., & New, N. (2015). The Self-Care Educational Intervention study: study protocol of a randomised controlled trial. Heart, Lung and Circulation, 24, Supplement 3, S221. doi:http://dx.doi.org/10.1016/j.hlc.2015.06.262
1. Boyde, M., Peters, R., Hwang, R., Korczyk, D., Ha, T., Wallace, N. (2016) The Self-Care Educational Intervention for Patients with Heart Failure: a study protocol. Journal of Cardiovascular Nursing, 32(2),165-170 DOI:10.1097/JCN.000000000000318
Boyde, M., Peters, R., New, N., Hwang, R., Ha.T., & Korczyk, D. (2018). Self-care educational intervention to reduce hospitalisations in heart failure: A randomised controlled trial. European Journal of Cardiovascular Nursing, 17(2), 178-185. doi:DOI: 10.1177/1474515117727740
Public notes

Contacts
Principal investigator
Name 34446 0
Dr Mary Boyde
Address 34446 0
199 Ipswich Road, Princess Alexandra Hospital, Woolloongabba 4102 QLD
Country 34446 0
Australia
Phone 34446 0
+61 7 31766333
Fax 34446 0
Email 34446 0
[email protected]
Contact person for public queries
Name 17693 0
Dr Mary Boyde
Address 17693 0
Cardiology
Princess Alexandra Hospital
Ipswich Road
Woolloongabba
QLD 4102
Country 17693 0
Australia
Phone 17693 0
+61 7 3176 6333
Fax 17693 0
Email 17693 0
[email protected]
Contact person for scientific queries
Name 8621 0
Dr Mary Boyde
Address 8621 0
Cardiology
Princess Alexandra Hospital
Ipswich Road
Woolloongabba
QLD 4102
Country 8621 0
Australia
Phone 8621 0
+61 7 3176 6333
Fax 8621 0
Email 8621 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No individual data is available for sharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Boyde, M., et al. (2018). "Self-care educational i... [More Details]

Documents added automatically
No additional documents have been identified.