Quality of LifeNCT03391999
Health-Related Quality of Life in Upper Secondary Schools in Denmark
An observational study of Quality of Life, run by Aalborg University at 1 site in Denmark.
Trial summary
Measuring Quality of Life in an upper secondary school in Denmark Read more about this study
- Who is it for?
- Ages 15 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Life
- What is being tested?
- A questionnaire; CHU9D
- How many people
- 300 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Oct 2017to 1 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 22 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Young adults enrolled at the Technical College in Aars
Who may be able to join
- Students at the Higher Commercial Examination (HHX) and Higher Technical Examination (HTX) at the Technical College in Aars.
Who cannot join
- There will be no exclusion criteria concerning diseases or conditions for these school students.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: (Danish): Sundhed, Trivsel og Læring på HHX og HTX, Erhvervsskolerne i Aars
Measuring Quality of Life in an upper secondary school in Denmark
Read the 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.
- Conditions
- Quality of Life
- Being tested
- A questionnaire; CHU9D
- Keywords
- Mental Health, Physical Health
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A questionnaire; CHU9DOther
Measuring Health Related Quality of Life
What is being measured
The primary outcome is the main question the study is designed to answer.
QALY
Quality Adjusted Life Years
Measured: 3-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start15 Oct 2017
- Primary completion30 Jul 2020 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karin Dam Petersen, Aalborg University
- Investigators
- Birgitte Gregersen, PhD, Study director, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03391999
- Sponsor's protocol ID
- AalborgU
- Status last verified
- Jul 2019
- First submitted
- 2 Jan 2018
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Only sharing IPD with the upper secondary school and my research group
Publications
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.
PubMed 31870369
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (Danish): Sundhed, Trivsel og Læring på HHX og HTX, Erhvervsskolerne i Aars
- ClinicalTrials.gov ID
- NCT03391999
- Acronym / sponsor ID
- AalborgU
- Conditions
- Quality of Life
- Keywords
- Mental Health, Physical Health
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 15 Oct 2017 (actual)
- Primary completion
- 30 Jul 2020 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 5 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Young adults enrolled at the Technical College in Aars
Key inclusion criteria (1 listed)
- Students at the Higher Commercial Examination (HHX) and Higher Technical Examination (HTX) at the Technical College in Aars.
Key exclusion criteria (1 listed)
- There will be no exclusion criteria concerning diseases or conditions for these school students.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A questionnaire; CHU9DMeasuring Health Related Quality of Life | Other | – |
Primary outcome
QALY
Time frame: 3-5 years
Quality Adjusted Life Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Derived from this study: PubMed 31870369Petersen 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.
- Individual participant dataSharing planned: Undecided. Only sharing IPD with the upper secondary school and my research group
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Birgitte Gregersen, PhD study director
Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life, run by Aalborg University at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QALY (time frame: 3-5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03391999, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2020.