Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000099426
Ethics application status
Approved
Date submitted
25/01/2016
Date registered
1/02/2016
Date last updated
1/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating a self-management program to improve knowledge and self-care for people with heart failure (HF) in Vietnam
Scientific title
A self-management program for people with heart failure (HF) to improve knowledge and self-care in Vietnam: A cluster randomised trial
Secondary ID [1] 288416 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart failure 297428 0
Condition category
Condition code
Cardiovascular 297611 297611 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a self-management program consisting of a one-hour individual educational session, provision of a HF booklet, a diary and weighing scale. Participants receive the self-management program at discharge. The booklet is adapted with permission from the Australian National Heart Foundation. The one-hour individual educational session aims to provide participants with knowledge and self-management in heart failure. Educational topics which are delivered by a trained nurse cover HF signs and symptoms, symptom management, advice regarding fluid and weight management, salt restrictions, medication use, exercise, recognition of worsening symptoms and alerting signs to seek help. The teach-back method is used as a teaching method to ensure understanding of information provided during educational session and during one follow-up phone call 2 weeks after that. The follow-up phone call (takes approximately 10 minutes) is purposeful to reinforce educational messages and promote adherence. The participants are taught how and when to measure their weight and to record in the diary. The diary also provides space for participants to record their symptoms, amount of fluid intake, blood pressure and list of medications.
Intervention code [1] 293727 0
Lifestyle
Intervention code [2] 293764 0
Treatment: Other
Comparator / control treatment
Standard care currently delivered to people with HF in the setting. Standard education is given mostly by a medical physician on the basis of patient’s clinical conditions and does not specifically target to HF self-management. The education is brief and provided once at discharge. Each participant in the control group also receives the HF self-management booklet identical with the intervention. The researcher explains briefly the content of the booklet but does not require them to teach-back. No follow up is provided.
Control group
Active

Outcomes
Primary outcome [1] 297156 0
The primary outcome 1: heart failure knowledge. This is measured by the Dutch HF Knowledge Scale. The scale has been validated in Vietnamese population in a previous study.
Timepoint [1] 297156 0
Time point 1: one month after enrollment.
Time point 2: three months after enrollment.
Primary outcome [2] 297157 0
Primary outcome 2: mean HF self-care score. This is assessed by the Self-care for Heart Failure Index. The instrument is translated and validated in Vietnamese by the researcher.
Timepoint [2] 297157 0
Time point 1: one month after enrollment.
Time point 2: three months after enrollment.
Secondary outcome [1] 320189 0
Secondary outcomes: All-cause hospital readmission measured by participants' report.


Timepoint [1] 320189 0
Time point 1: one month after enrollment
Time point 2: three months after enrollment
Secondary outcome [2] 320277 0
Secondary outcome: Cardiac-cause hospital readmission measured by participants' report
Timepoint [2] 320277 0
Time point 1: one month after enrollment
Time point 2: three months after enrollment

Eligibility
Key inclusion criteria
Adult patient aged 18-80 years old
New York Heart Association category II-IV heart failure diagnosis within 3 months
Competent in Vietnamese language
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Critically ill, cognitively impaired, visionally impaired, pregnant, waiting for surgery

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
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
The sample size is calculated to estimate 80% power, two-sided 5% significance level, type I error 0.05, type II error 0.2, mean change of HF knowledge 1.61 (SD 2.2), cluster size 20, intra-cluster correlation coefficient 0.05, the needed sample size is 140.
The study follows intention to treat principles. Linear mixed models are used to determine the change in continuous outcomes. Risk ratio is used to compare hospital readmissions in two study groups

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
19/08/2014
Date of last participant enrolment
Anticipated
Actual
30/10/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
140
Recruitment outside Australia
Country [1] 7554 0
Viet Nam
State/province [1] 7554 0
Hanoi

Funding & Sponsors
Funding source category [1] 292762 0
University
Name [1] 292762 0
Queensland University of Technology – Atlantic Philanthropies Vietnam Nursing Project Scholarship
Country [1] 292762 0
Australia
Primary sponsor type
University
Name
School of Nursing Queensland University of Technology
Address
Victoria Park Road, Kelvin Grove QLD 4059
Country
Australia
Secondary sponsor category [1] 291496 0
None
Name [1] 291496 0
Address [1] 291496 0
Country [1] 291496 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294249 0
Queensland University of Technology University Human Research Ethics Committee Office of Research Ethics and Integrity
Ethics committee address [1] 294249 0
Level 4, 88 Musk Avenue, Kelvin Grove QLD 4059
Ethics committee country [1] 294249 0
Australia
Date submitted for ethics approval [1] 294249 0
Approval date [1] 294249 0
16/06/2014
Ethics approval number [1] 294249 0
1400000374

Summary
Brief summary
The aim of this study is to examine the effectiveness of a self-management program for adult people with heart failure. The anticipated study outcome will be improved heart failure knowledge and self-care and less hospital readmission.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 738 738 0 0
/AnzctrAttachments/369937-RCT protocol.docx
Attachments [2] 739 739 0 0
/AnzctrAttachments/369937-ETH_Info-Consent_Heart Failure_20140616.doc
Attachments [3] 740 740 0 0
/AnzctrAttachments/369937-QUT ETHICS APPROVAL CERT 1400000374.pdf

Contacts
Principal investigator
Name 62806 0
Mrs Ha Dinh Thi Thuy
Address 62806 0
School of Nursing
Queensland University of Technology
Victoria Park Road, Kelvin Grove, QLD 4059
Country 62806 0
Australia
Phone 62806 0
+ 61-420402403
Fax 62806 0
Email 62806 0
dinhthithuy.ha@hdr.qut.edu.au
Contact person for public queries
Name 62807 0
Ha Dinh Thi Thuy
Address 62807 0
School of Nursing
Queensland University of Technology
Victoria Park Road, Kelvin Grove, QLD 4059
Country 62807 0
Australia
Phone 62807 0
+61-420402403
Fax 62807 0
Email 62807 0
dinhthithuy.ha@hdr.qut.edu.au
Contact person for scientific queries
Name 62808 0
Ha Dinh Thi Thuy
Address 62808 0
School of Nursing
Queensland University of Technology
Victoria Park Road, Kelvin Grove, QLD 4059
Country 62808 0
Australia
Phone 62808 0
+61-420402403
Fax 62808 0
Email 62808 0
dinhthithuy.ha@hdr.qut.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
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