Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001294741
Ethics application status
Approved
Date submitted
20/11/2013
Date registered
21/11/2013
Date last updated
4/02/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Asthma Self-Management for Adolescents in Taiwan
Scientific title
A randomized controlled trial to determine the effectiveness of an asthma self-management program in improving self-efficacy in Taiwan: a study protocol
Secondary ID [1] 283629 0
Nil
Universal Trial Number (UTN)
U1111-1150-6196
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 290569 0
Condition category
Condition code
Respiratory 290962 290962 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The asthma self-management program was developed using Bandura’s self-efficacy model. This study aims to develop a new asthma self-management program by enhancing the self-efficacy of adolescents in managing their asthma, thereby improving symptoms of asthma. The contents of the asthma self-management are based on the Expert Panel Report-3 (EPR-3) of the National Heart, Lung, and Blood Institute in the US (2007), including assessing and monitoring asthma severe and asthma control, control of environment factor and comorbid condition that affect asthma, medication, and educational for a partnerships in care. The asthma self-management program for the intervention group will be carrying out by the researcher who is a registered nurse, involves three face-to-face 30-40 minute meetings with participants from Week 1 to Week 3 and a 20 minutes mobile phone reminder call in Week 4. The aim of the phone call is to identify problems, give support and revision of information provided in the meetings sessions, and help adolescents with asthma to solve any problem they face in practicing their asthma action plan. During the discussion, the researcher will give positive feedback and encouragement about their effective behaviors in order to achieve confidence in carrying out asthma self-management. Following each of the first three face-to-face meetings a text message will be sent to remind participants to use their medication, encourage them, and motivate them.
The asthma self-management program, which is 4 weeks duration, will be carrying by the researcher. During the study period, participants in the intervention group will be asked to record their daily asthma symptoms, name of the asthma medicine, and peak expiratory flow rate. After the 4-week period of the intervention, post data will be collected again
Intervention code [1] 288324 0
Behaviour
Intervention code [2] 288330 0
Other interventions
Comparator / control treatment
The usual asthma care in the control group is conducted by the outpatient department of nursing at the pediatric outpatient department , which is based on the guidelines of the Bureau of Health Promotion in Taiwan. The contents of asthma care include the nature of asthma; controlling triggers of asthma; manipulation of peak flow meter; medication usage; assessment of severity of asthma; and introduction of diary of asthma symptoms and signs, according to the Bureau of health promotion in Taiwan. The contents will be divided into three sessions: first sessions is introduction what is asthma, control of environment factors, and medication. Secondary , inhaler using , and explanation diary of symptoms and sign of asthma. The final session is to evaluate patients inhaler manipulation and understand how to avoidance of trigger. Each time is from 10-20 minutes for a newly diagnosed with asthma. The strategies in the control groups are lecturing and dialogue. In addition, information about how to correctly manipulate inhaler is presented by DVD. The time is about 5 minutes.
Control group
Active

Outcomes
Primary outcome [1] 290942 0
The Asthma Management Self-Efficacy index will be used to evaluate adolescents’ asthma self-efficacy.
Timepoint [1] 290942 0
baseline and 4-week post intervention
Secondary outcome [1] 305636 0
Outcome expectation as assessed using the questionnaire of Outcome Expectancy.
Timepoint [1] 305636 0
Baseline and 4-week post intervention
Secondary outcome [2] 305653 0
level of asthma control as assessed using the Asthma Control Test.
Timepoint [2] 305653 0
baseline and 4-week post the intervention
Secondary outcome [3] 305654 0
asthma self-management behaviors as assessed by using the Asthma Self-management Indices
Timepoint [3] 305654 0
baseline and 4-week post intervention

Eligibility
Key inclusion criteria
1.Diagnosed with asthma which is persistent moderate or persistent severe for at least 3 months as assessed by a physician. Aged between 12 and 18 years
2.Able to converse in Mandarin/Taiwanese
3.Having a mobile phone and be able to use it.
Minimum age
12 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
potential participants are participating in another research protocol and have a chronic comorbid condition that may affect participants’ carry out asthma self-management behaviors, they will exclude to attend this study.

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)
Sealed opaque envelops
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The sample size of this study was calculated using a significance level was established at 5% to avoid a type I error, and power was set at 80% to avoid type II error, and one-tail, at least a difference of 6.3 units between the control and experimental groups in scores of self-efficacy, according to Pichora’s research. The result indicated that 39 per group is needed. Furthermore, the anticipated attrition rate of respondents of past study of adolescent’s self-management is 19.1%. Therefore, a total of 94 participants (47 per group) will be recruited.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2014
Actual
24/02/2014
Date of last participant enrolment
Anticipated
Actual
30/08/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
94
Accrual to date
Final
Recruitment outside Australia
Country [1] 5649 0
Taiwan, Province Of China
State/province [1] 5649 0

Funding & Sponsors
Funding source category [1] 288314 0
University
Name [1] 288314 0
Queensland University of Technology
Country [1] 288314 0
Australia
Primary sponsor type
University
Name
QUT
Address
Queensland University of Technology, Victoria park Road, Kelvin Grove, Australia Q4059
Country
Australia
Secondary sponsor category [1] 287030 0
University
Name [1] 287030 0
Queensland University of Technology
Address [1] 287030 0
Queensland University of Technology, Victoria park Road, Kelvin Grove, Australia Q4059
Country [1] 287030 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290211 0
Chang Gung Foundation Institutional Review Board
Ethics committee address [1] 290211 0
Ethics committee country [1] 290211 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 290211 0
16/09/2013
Approval date [1] 290211 0
18/11/2013
Ethics approval number [1] 290211 0

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

Contacts
Principal investigator
Name 44466 0
Miss Tseng, Tzu-Jung
Address 44466 0
School of Nursing, Queensland University of Technology, Victoria park Road, Kelvin Grove, Australia Q4059
Country 44466 0
Australia
Phone 44466 0
+61 7 31380578
Fax 44466 0
Email 44466 0
[email protected]
Contact person for public queries
Name 44467 0
Tseng, Tzu-Jung
Address 44467 0
School of Nursing, Queensland University of Technology, Victoria park Road, Kelvin Grove, Australia Q4059
Country 44467 0
Australia
Phone 44467 0
+61 7 31380575
Fax 44467 0
Email 44467 0
[email protected]
Contact person for scientific queries
Name 44468 0
Tseng, Tzu-Jung
Address 44468 0
School of Nursing, Queensland University of Technology, Victoria park Road, Kelvin Grove, Australia Q4059
Country 44468 0
Australia
Phone 44468 0
+61 7 31380575
Fax 44468 0
Email 44468 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
EmbaseA randomized control trial of an asthma self-management program for adolescents in Taiwan: A study protocol.2017https://dx.doi.org/10.1016/j.conctc.2017.09.005
EmbaseA multimodal approach to improve asthmatic adolescents' self-efficacy in Taiwan.2022https://dx.doi.org/10.1093/inthealth/ihab081
N.B. These documents automatically identified may not have been verified by the study sponsor.