Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001244493
Ethics application status
Approved
Date submitted
17/02/2014
Date registered
6/09/2016
Date last updated
6/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Game for Health: Development of a modular eHealth resource for children and adolescents with chronic illness
Scientific title
Game for Health: Development of a modular eHealth resource for children and adolescents with chronic illness
Secondary ID [1] 284109 0
Nil
Universal Trial Number (UTN)
U1111-1153-4598
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Illness (e.g. asthma, diabetes, cystic fibrosis, etc.) in children and adolescents 291185 0
Condition category
Condition code
Mental Health 291522 291522 0 0
Anxiety
Other 300066 300066 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Sample and data collection
Children and young people with long term physical conditions, their parents and paediatricians were recruited by advertising via posters and flyers conveyed by clinicians at Starship Children’s Hospital in Auckland. Paediatricians at the same hospital were invited to participate via email. General practitioners were recruited through a colleague at the University of Auckland.

Ethics
Ethical approval for the study was obtained from the New Zealand Northern Region Ethics Committee (Ref 13/NTA/234/AM01). Written participant consent was obtained for those aged 16 or older. Written parental consent was obtained for those aged 15 and under.

Focus Groups
Most focus groups were undertaken by three of the authors (HT, VG and KS) at Starship Children’s Hospital in Auckland. The general practitioner focus group was conducted at a private residence in Auckland. All focus groups lasted between 90-120 minutes and were conducted in a similar manner using a semi-structured interview format starting with their general knowledge and later their specific use of eHealth interventions. They were then shown three demonstration or video clips of existing health games (Quest for the Code (Registered trademark), a physical health-related game designed for younger children), Re-Mission (Registered trademark), a physical health game designed for older children and SPARX (Registered trademark), a mental health game designed for young people) and asked their opinion about each. Finally, they were asked for ideas regarding potential new eHealth interventions that may be useful to them or their patients and factors that may influence use of or recommendation of such interventions.

The interviewers included HT, a child psychiatrist and paediatrician, employed at Starship Children’s Hospital, KS, a research fellow at the University of Auckland and VS, a health psychology intern who was working in private practice. HT did not know any of the young people, children or parents prior to the focus groups, but did know the paediatricians. HT and KS knew one of the general practitioners who attended one of the clinician focus groups.

Data Analysis
All groups were digitally recorded and commentary was transcribed verbatim and analysed using a general inductive approach (GIA)28. Transcribed data was coded by HT using QSR NVivo 10 software. Statements of interest were identified as notes across transcripts, arranged into groups of nodes and these were reviewed to identify common themes and relationships pertaining to the research question. Approximately 30% of transcripts were cross-coded by KS for validation of the coding process. Any discrepancies were discussed by the coders until consensus was reached. Representative quotes were selected by HT and KS to illustrate each theme. Preliminary results were reviewed by a subset of participants and their feedback was incorporated before the analysis was finalised.
Intervention code [1] 288803 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291491 0
To determine the needs and wants of children and adolescents with chronic illness in order to design a set of modular interactive eHealth programmes through focus group discussion.
Timepoint [1] 291491 0
December 2015
Secondary outcome [1] 327477 0
None
Timepoint [1] 327477 0
None

Eligibility
Key inclusion criteria
There will be three groups of participants:
1) Young people (children and adolescents): Participants will be included if they are 7-19 years of age, if they speak English, consent/assent to participate and if they sought medical care for chronic health conditions including asthma, etc. from a paediatrician or general practitioner within the ADHB area.
2) Parents/guardians/whanau members: Participants will be included if they are parents/guardians of a child with a chronic health conditions such as asthma, etc., who have sought care from a a paediatrician or general practitioner within the ADHB area, if they speak English and consent to participate.
3) Clinicians: Participants will be included (in the focus groups, interviews, survey) if they are paediatricians or general practitioners who are providing care to children with chronic health conditions such as asthma, etc. within the ADHB area and who consent to participate.
Minimum age
7 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People who do not consent to participating or are unable to provide written and verbal consent to participate in focus groups.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/10/2014
Date of last participant enrolment
Anticipated
Actual
31/12/2014
Date of last data collection
Anticipated
31/01/2015
Actual
31/01/2015
Sample size
Target
70
Accrual to date
Final
50
Recruitment outside Australia
Country [1] 5830 0
New Zealand
State/province [1] 5830 0
Auckland

Funding & Sponsors
Funding source category [1] 288740 0
Charities/Societies/Foundations
Name [1] 288740 0
Oakley Foundation
Country [1] 288740 0
New Zealand
Funding source category [2] 294463 0
Charities/Societies/Foundations
Name [2] 294463 0
Starship Foundation
Country [2] 294463 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Oakley Foundation
Address
PO Box 68232 Newton, Auckland 1145
Country
New Zealand
Secondary sponsor category [1] 287436 0
None
Name [1] 287436 0
Address [1] 287436 0
Country [1] 287436 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290574 0
Northern Regional Ethics Committee
Ethics committee address [1] 290574 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6140
Ethics committee country [1] 290574 0
New Zealand
Date submitted for ethics approval [1] 290574 0
Approval date [1] 290574 0
24/01/2014
Ethics approval number [1] 290574 0
13/NTA/234

Summary
Brief summary
Context: Children with chronic health conditions (such as asthma, cystic fibrosis, diabetes) often experience significant discomfort, reduced quality of life and more psychosocial difficulties than their healthy peers. Psychological and behavioural interventions have been shown to be effective in improving knowledge of condition, self-management skills, treatment adherence and functional status. Recently, e-therapy/eHealth interventions, such as an award winning and locally developed SPARX (a computer game for treating depression), have been shown to be clinically effective. Currently, in New Zealand, there are no paediatric eHealth interventions for chronic health conditions.
Objectives: The proposed research is the first step of our goal to develop and evaluate a set of modular interactive eHealth programs for children with chronic health conditions which can be used within primary level and paediatric environments.
Method: This preliminary study comprises two parts:
1) An exploratory (mixed methodology – qualitative and quantitative research) study with key stakeholders: experts (young people, medical professionals, parents/whanau, learning technology/IT experts) to determine the 'needs and wants' and the possible technology on which to design and deliver the intervention. This will be done via a series of 12 focus groups and an online survey.
2) A systematic (Cochrane) review of literature to assess the current knowledge/practice and inform the design of intervention.
Benefits: The findings of this phase of research will inform the next phase of work, i.e. the development of the first of a series of eHealth intervention modules
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 46302 0
Dr Hiran Thabrew
Address 46302 0
Senior Lecturer, Department of Psychological Medicine, 12th floor, Support Block, Auckland Hospital, Park Road, Grafton Private Bag 92019 Auckland 1142
Country 46302 0
New Zealand
Phone 46302 0
0064 27 706 8557
Fax 46302 0
Email 46302 0
[email protected]
Contact person for public queries
Name 46303 0
Dr Hiran Thabrew
Address 46303 0
Senior Lecturer, Department of Psychological Medicine, 12th floor, Support Block, Auckland Hospital, Park Road, Grafton Private Bag 92019. Auckland 1142
Country 46303 0
New Zealand
Phone 46303 0
0064 27 706 8557
Fax 46303 0
Email 46303 0
[email protected]
Contact person for scientific queries
Name 46304 0
Dr Hiran Thabrew
Address 46304 0
Senior Lecturer, Department of Psychological Medicine, 12th floor, Support Block, Auckland Hospital, Park Road, Grafton Private Bag 92019. Auckland 1142
Country 46304 0
New Zealand
Phone 46304 0
0064 27 706 8557
Fax 46304 0
Email 46304 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

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