Health-Related Quality of Life in Upper Secondary Schools... | NCT03391999

Studies
Health-Related Quality of Life in Upper Secondary Schools in Denmark

NCT03391999

Sponsor

Aalborg University

Status

Unknown status

Last Update Posted

Jul 9, 2020Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Quality of Life

Interventions

A questionnaire; CHU9D

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 15, 2017Actual

Primary Completion Date

Jul 30, 2020Estimated

Completion Date

Jan 1, 2022Estimated

First Submitted Date

Jan 2, 2018

First Submission Date that Met QC Criteria

Jan 2, 2018

First Posted Date

Jan 5, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2020

Last Update Posted Date

Jul 9, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Measuring Quality of Life in an upper secondary school in Denmark

Detailed Description

The Child Health Utility 9 Dimension (CHU9D) is a relatively new health-related quality of life (HRQoL) instrument for use in children and young people. CHU9D has recently been translated and linguistic validated into Danish.

The objective of this study is twofold. Firstly, the investigators wants to examine the feasibility of using the Danish version of CHU9D to assess the HRQoL in young adults. Secondly, the investigators wants to analyse the association of wellbeing, happiness with the school and the learning environment with the students HRQoL in the Northern Danish Region of Denmark.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
A questionnaire; CHU9D	Other	Measuring Health Related Quality of Life

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
QALY	Quality Adjusted Life Years	3-5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Students at the Higher Commercial Examination (HHX) and Higher Technical Examination (HTX) at the Technical College in Aars.

Exclusion Criteria:

There will be no exclusion criteria concerning diseases or conditions for these school students.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

22 Years

Standard Ages

ChildAdult

Study Population

Young adults enrolled at the Technical College in Aars

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Birgitte Gregersen, PhD	Aalborg University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aalborg University		Aalborg		9220	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31870369	Derived	Petersen KD, Ratcliffe J, Chen G, Serles D, Frosig CS, Olesen AV. The construct validity of the Child Health Utility 9D-DK instrument. Health Qual Life Outcomes. 2019 Dec 23;17(1):187. doi: 10.1186/s12955-019-1256-0.

ID	Term
D010549	Personal Satisfaction
D001519	Behavior