Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000646842
Ethics application status
Approved
Date submitted
2/04/2021
Date registered
31/05/2021
Date last updated
31/05/2021
Date data sharing statement initially provided
31/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Quality of Little Lives Study (QuoLL) - Investigating an adapted quality of life questionnaire for children aged 2-4 years.
Scientific title
Quality of Little Lives Study (QuoLL) - Usability of an adapted EQ-5D-Y for use in children aged 2-4 years
Secondary ID [1] 303848 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
QuoLL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 321399 0
Autism Spectrum Disorder 321400 0
Sleep problems 321401 0
Dental decay 321402 0
Anxiety 321403 0
Attention Deficit Hyperactivity Disorder 321404 0
Acutely unwell requiring Emergency medicine 321405 0
Behaviour problems 321406 0
Bowel problems 321407 0
Diabetes 321408 0
Neurological disorders 321409 0
Dental problems requiring day surgery 321410 0
Developmental disabilities 321411 0
Depression 321412 0
Developmental delay 321768 0
Bladder problems 321769 0
Ear problems
 321770 0
Nose problems
321771 0
Throat problems
321772 0
Orthopaedic 321773 0
Condition category
Condition code
Respiratory 319163 319163 0 0
Asthma
Mental Health 319164 319164 0 0
Autistic spectrum disorders
Oral and Gastrointestinal 319165 319165 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Mental Health 319167 319167 0 0
Anxiety
Mental Health 319168 319168 0 0
Depression
Mental Health 319169 319169 0 0
Other mental health disorders
Neurological 319170 319170 0 0
Epilepsy
Emergency medicine 319171 319171 0 0
Other emergency care
Metabolic and Endocrine 319172 319172 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study is to test the administration of the EQ-5D-Y proxy survey adapted for children aged 2-4 years involving the prospective data collection of several paediatric health related quality of life (HRQoL) instruments (including the EQ-5D-Y proxy survey adapted for children aged 2-4 years) via two surveys completed by the caregiver (proxy), an initial 15-30-minute survey and a retest follow-up 5 minute survey 2-8 weeks later.

The initial survey will include the following questionnaires: Informed Consent, Demographic Information, Carer Quality of Life (EQ-HWB), Strengths and Difficulties Questionnaire (SDQ), Pediatric Quality of Life Inventory (PedsQL), Toddler and Infant Health Related Quality of Life (TANDI), EQ-5D-Y adapted (3L and 5L), EQ-5D-Y VAS, Child Health Utility (CHU9D), Global Health Measure, Health Utilities Index (HUI2/3) and relevant disease-specific questionnaires: Asthma PedsQL, KIDSCREEN-27: Health Questionnaire for Children and Young People, Sleep disturbances Scale For Children (SDSC), Child Perceptions Questionnaire (CPQ), Revised Child Anxiety and Depression Scale 25 (RCADS-25), ADHD-Symptoms and Normal-Behaviors (SWAN). Participants will also be asked to report the difficulty of each instrument.

The follow-up survey will include: PedsQL, TANDI, EQ-5D-Y adapted (3L and 5L), EQ-5D-Y VAS, CHU9D and Global Health Measure. Participants will also be asked to report the difficulty of each instrument.

The performance of the adapted survey will be compared to that of the Global Health Measure, TANDI, CHU9D, HUI2/3 and PedsQL. Instruments will be assessed in terms of acceptability, feasibility, reliability, validity and sensitivity within the Australian context.

Caregivers of children will primarily be recruited by research assistants who will approach families face-to-face in waiting areas across the hospital and ask caregivers to complete the initial survey on an iPad or their own device (will be provided a QR code or text a link on the spot). Some participants will also be recruited via social media adverts, adverts on the virtual telehealth waiting room, or via online survey panels, these participants will complete the survey online via REDcap. The follow-up survey will be delivered online.

Participants may be enrolled into both the Quality of Kids' Lives Study and this study. The same specific disease subgroups will be assessed for this study.
Intervention code [1] 320152 0
Not applicable
Comparator / control treatment
The performance of instruments will be compared by child age and disease groups. Disease groups (Hospital sample, ADHD sample, anxiety or depression sample, ASD sample, asthma sample, dental decay sample and sleep problems sample) will be compared with well children (as defined by parent report of child health condition(s) in the demographic section of the initial survey).
Control group
Active

Outcomes
Primary outcome [1] 327045 0
Validity (the degree to which the HRQoL instrument measures the construct(s) it purports to measure) of the new adapted instrument compared to other pediatric HRQoL instruments (Global Health Measure, TANDI, CHU9D, HUI2/3 and PedsQL). Validity of instruments will be measured using within-scale analysis (measured using factor analysis), known group differences (measured by descriptively comparing a priori assumptions regarding expected differences between disease groups and healthy children), convergent validity (measured by analysing the correlation of similar constructs from different instruments hypothesised to measure similar constructs) and discriminant validity (measured by analysing whether dimension responses are independent of child age).
Timepoint [1] 327045 0
Both initial and follow-up surveys.
Primary outcome [2] 327046 0
Consistency (the degree to which the summary and dimension specific responses on each instrument are consistent with dimension and summary responses of other similar instruments) of the new adapted measure compared to other pediatric HRQoL instruments (Global Health Measure, TANDI, CHU9D, HUI2/3 and PedsQL). Consistency of instruments will be assessed by comparing the consistency of summary and dimension specific responses on each instrument.
Timepoint [2] 327046 0
Both initial and follow-up surveys.
Primary outcome [3] 327047 0
Acceptability and feasibility (composite primary outcome) of new adapted measure compared to other pediatric HRQoL instruments (Global Health Measure, TANDI, CHU9D, HUI2/3 and PedsQL). Acceptability and feasibility of instruments will be measured by assessing the time to complete instruments (measured using web analytics), completeness of data (measured by analysing data missingness) and reported difficulty (measured by survey question asking participants to report how difficult instrument was to complete, a single item question designed specifically for this study).
Timepoint [3] 327047 0
Both initial and follow-up surveys.
Secondary outcome [1] 394833 0
Primary outcome: Reliability (the stability of the instrument) of the new adapted instrument compared to other paediatric HRQoL instruments (Global Health Measure, TANDI, CHU9D, HUI2/3 and PedsQL). Reliability of instruments will be assessed using test-retest reliability, measured by agreement on dimension-level responses between the initial survey to the re-test survey 2-8 weeks later.
Timepoint [1] 394833 0
Both initial and follow-up surveys.
Secondary outcome [2] 394834 0
Primary outcome: Responsiveness (the ability of an instrument to detect change in the construct to be measured) of the new adapted measure compared to other pediatric HRQoL instruments (Global Health Measure, TANDI, CHU9D, HUI2/3 and PedsQL). Responsiveness of instruments will be assessed using dimension level responses from children whose proxy respondents reported a change in general status from the initial survey to the re-test survey 2-8 weeks later in comparison to those not showing a change. This will be assessed to determine the extent to which instruments are responsive to change in general status.
Timepoint [2] 394834 0
Both initial and follow-up surveys.

Eligibility
Key inclusion criteria
Parent/caregiver of a child(ren) aged of 2-4 years old (inclusive) at enrolment.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Is unable to communicate in written English. Language will be simplified as much as possible to allow inclusion of caregivers who might have limited English proficiency
• Reside outside of Australia
• Unable to answer or comprehend questions

Study design
Purpose
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Performance will be analysed and compared at summary, dimension and item levels using psychometric analyses. Additionally, the feasibility, acceptability and responsiveness of the various instruments will be compared.

Sample size calculation has not been performed due to a lack of data available to inform how expected responses are likely to be distributed or compare to other QoL measures. We considered it more important to ensure a heterogenous sample in child/family characteristics and in child health-related quality of life. This diversity in the sample is important to determine the validity and applicability of the HRQoL instruments to groups of children. We had considered a smaller sample size which would have allowed for shorter study period and smaller budget, however we settled on 400 participants to ensure the rigor needed for the analyses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/06/2021
Actual
Date of last participant enrolment
Anticipated
31/01/2022
Actual
Date of last data collection
Anticipated
14/02/2022
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19048 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 33596 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 308243 0
Charities/Societies/Foundations
Name [1] 308243 0
EuroQol group
Country [1] 308243 0
Netherlands
Primary sponsor type
Charities/Societies/Foundations
Name
EuroQol group
Address
EuroQol Office
Marten Meesweg 107
3068 AV Rotterdam, The Netherlands
Country
Netherlands
Secondary sponsor category [1] 309036 0
None
Name [1] 309036 0
Address [1] 309036 0
Country [1] 309036 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308223 0
The Royal Children's Hospital Human Research Ethics Committee (HREC)
Ethics committee address [1] 308223 0
Ethics committee country [1] 308223 0
Australia
Date submitted for ethics approval [1] 308223 0
25/02/2021
Approval date [1] 308223 0
20/05/2021
Ethics approval number [1] 308223 0
HREC/71963/RCHM-2021

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

Contacts
Principal investigator
Name 109982 0
A/Prof Kim Dalziel
Address 109982 0
Health Economics Unit
Level 4, 207 Bouverie Street
The University of Melbourne
Melbourne School of Population and Global Health
Parkville, Victoria, 3010, Australia
Country 109982 0
Australia
Phone 109982 0
+61 3 9345 5522
Fax 109982 0
Email 109982 0
[email protected]
Contact person for public queries
Name 109983 0
Kim Dalziel
Address 109983 0
Health Economics Unit
Level 4, 207 Bouverie Street
The University of Melbourne
Melbourne School of Population and Global Health
Parkville, Victoria, 3010, Australia
Country 109983 0
Australia
Phone 109983 0
+61 3 9345 5522
Fax 109983 0
Email 109983 0
[email protected]
Contact person for scientific queries
Name 109984 0
Kim Dalziel
Address 109984 0
Health Economics Unit
Level 4, 207 Bouverie Street
The University of Melbourne
Melbourne School of Population and Global Health
Parkville, Victoria, 3010, Australia
Country 109984 0
Australia
Phone 109984 0
+61 3 9345 5522
Fax 109984 0
Email 109984 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
Due to privacy restrictions of health data and the potentially sensitive and identifiable nature of this data no IPD will be publicly available.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11245Study protocol    381731-(Uploaded-30-04-2021-16-14-12)-Study-related document.docx
11246Informed consent form    381731-(Uploaded-30-04-2021-16-14-30)-Study-related document.docx



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.