Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000400561
Ethics application status
Approved
Date submitted
8/09/2006
Date registered
12/09/2006
Date last updated
9/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving childhood asthma management through a telemedicine monitoring network
Scientific title
Improving childhood asthma management through a telemedicine monitoring network
Secondary ID [1] 287834 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 1366 0
Condition category
Condition code
Respiratory 1459 1459 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A pilot, formal randomised controlled trial (RCT) to examine the benefits of chronic disease monitoring
1. Interactive Voice Response (IVR) Monitoring Patients will be assigned to a category of asthma based on symptoms over the previous 12 months according to National Asthma Campaign guidelines: Episodic asthma - 60,Persistent asthma - 60. Patients will be randomised into three groups:(a) Regular care(control) group: GP/Paediatrician, hospital emergency services (b) Telemedicine (intervention) group: twice a week automated telephone calls to the family (c) Nurse support group: Telephone call by an asthma nurse every two weeks.
2. Short Message Service (SMS) Monitoring
40 adolescents with asthma will be randomised to monitoring via mobile phone using SMS (20 patients) and control group with regular care from primary physician or specialist (20 patients).
Intervention code [1] 1355 0
Other interventions
Comparator / control treatment
Control group with regular care from primary physician or specialist (20 patients).
Control group
Active

Outcomes
Primary outcome [1] 2011 0
Health resource utilisation over a 6 month period
Timepoint [1] 2011 0
6 months
Primary outcome [2] 2012 0
Health economic assessment over a 6 month period
Timepoint [2] 2012 0
6 months
Secondary outcome [1] 3484 0
1. School days missed (children) and days off work (parents)
Timepoint [1] 3484 0
Over a six-month period.
Secondary outcome [2] 3485 0
2. Use of medications
Timepoint [2] 3485 0
Over a six-month period.
Secondary outcome [3] 3486 0
3. Health related Quality of Life (QOL)
Timepoint [3] 3486 0
Over a six-month period.

Eligibility
Key inclusion criteria
120 children and young people with established doctor diagnosis of episodic or persistent asthma who have had at least one admission to hospital or one episode of acute care in an emergency department or paediatric clinic or general practitioner for asthma requiring steroid rescue within the previous 12 months. Suitable SMS patients will be required to have a mobile phone. Potential participants will be identified from the separation reports provided by participating hospitals.
Minimum age
3 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with other significant respiratory or medical disorders. 2. Patients who are currently participating in other studies or drug trials.3. Families where informed consent cannot be obtained.

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)
Participant identification number lists will be created prior to the study. Randomisation lists will be prepared that link these ID numbers to an allocation to a study group by using a random number generator in the statistical software package Stata. This is done by Biostatistical Unit at Monash University.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation will be stratified by centre, gender, age group and asthma category for the IVR, and gender and centre for the SMS. When enrolling participants, study staff will use the next ID number in sequence on the pre-prepared ID list and will then ascertain from the separate randomisation list the group to which this ID number (participant) is randomised. Recruitment and randomisation are separated i.e. the person who assigns a study ID to participants has no access to the randomisation list.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/09/2006
Actual
1/09/2006
Date of last participant enrolment
Anticipated
Actual
30/09/2007
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
160
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1596 0
Charities/Societies/Foundations
Name [1] 1596 0
Asthma Foundations of Australia
Country [1] 1596 0
Australia
Funding source category [2] 1597 0
Charities/Societies/Foundations
Name [2] 1597 0
Royal Children's Hospital Foundation
Country [2] 1597 0
Australia
Primary sponsor type
Hospital
Name
Royal Children's Hospital, Brisbane
Address
Herston Rd
Herston 4029
Country
Australia
Secondary sponsor category [1] 1402 0
University
Name [1] 1402 0
The University of Queensland Centre for Online Health
Address [1] 1402 0
St Lucia 4071
Country [1] 1402 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3044 0
RCH Brisbane
Ethics committee address [1] 3044 0
Ethics committee country [1] 3044 0
Australia
Date submitted for ethics approval [1] 3044 0
Approval date [1] 3044 0
06/06/2005
Ethics approval number [1] 3044 0
2005/036
Ethics committee name [2] 3045 0
Redcliffe and Caboolture Hospitals
Ethics committee address [2] 3045 0
Ethics committee country [2] 3045 0
Australia
Date submitted for ethics approval [2] 3045 0
Approval date [2] 3045 0
05/10/1945
Ethics approval number [2] 3045 0
12/10/2005
Ethics committee name [3] 3046 0
Ipswich Hospital
Ethics committee address [3] 3046 0
Ethics committee country [3] 3046 0
Australia
Date submitted for ethics approval [3] 3046 0
Approval date [3] 3046 0
10/08/2006
Ethics approval number [3] 3046 0
7/05N
Ethics committee name [4] 3047 0
Gold Coast Hospital
Ethics committee address [4] 3047 0
Ethics committee country [4] 3047 0
Australia
Date submitted for ethics approval [4] 3047 0
Approval date [4] 3047 0
22/02/2006
Ethics approval number [4] 3047 0
200610

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

Contacts
Principal investigator
Name 27962 0
Prof Claire Wainwright
Address 27962 0
5a Dept. of Respiratory & Sleep Medicine
Lady Cilento Children's Hospital
Brisbane
Country 27962 0
Australia
Phone 27962 0
+617 3068 1111
Fax 27962 0
+61 7 3068 2309
Email 27962 0
[email protected]
Contact person for public queries
Name 10544 0
Joyce Cheney
Address 10544 0
5a Dept. of Respiratory & Sleep Medicine
Lady Cilento Children's Hospital
Brisbane
Country 10544 0
Australia
Phone 10544 0
+617 3069 7195
Fax 10544 0
+617 3068 2309
Email 10544 0
[email protected]
Contact person for scientific queries
Name 1472 0
Claire Wainwright
Address 1472 0
5a Dept. of Respiratory & Sleep Medicine
Lady Cilento Children's Hospital
Brisbane
Country 1472 0
Australia
Phone 1472 0
+617 3068 1111
Fax 1472 0
+617 3068 2309
Email 1472 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
No additional documents have been identified.