Infections, RotavirusNCT01592838
Impact on Quality of Hospital Care During Pre- and Post- Rotavirus (RV) Vaccination Introduction in Belgium
An observational study of Infections, Rotavirus, run by GlaxoSmithKline.
Trial summary
This study aims to investigate whether a change in the pattern of hospitalisation was observed in paediatric wards over the last 6 years (June 2004 - May 2010), whether a change in staff workforce availability was observed in paediatric wards over the last 6 years (during a whole year or during specific time periods… Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Infections, Rotavirus
- What is being tested?
- Data collection
- Type of treatment
- Vaccines
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Oct 2014
- 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 Up to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Children ≤15 years old hospitalised for any reason between June 2004 and May 2010.
Who may be able to join
- All children aged ≤15 years being hospitalised (with overnight stay or day clinic) for whatever reason during the study period
Who cannot join
- Not Applicable
About this study
Official title: Feasibility Pilot Study Assessing the Impact on the Quality of Hospital Care After the Introduction of Rotavirus Vaccination in Belgium
This study aims to investigate whether a change in the pattern of hospitalisation was observed in paediatric wards over the last 6 years (June 2004 - May 2010), whether a change in staff workforce availability was observed in paediatric wards over the last 6 years (during a whole year or during specific time periods of the year) and if changes of any of the variables measured during the observation period could be linked to the introduction of rotavirus vaccination.
Read the detailed description
This retrospective study will use data extracted from hospital databases during the period of the 1st of June 2004 until the 31st of May 2010. A coded list of all hospitalisations and of the different infection tests performed in children will be generated, together with a list of Full time equivalents (FTE) in paediatric ward and the number of sick leave days of the working personnel.
- Conditions
- Infections, Rotavirus
- Being tested
- Data collection
- Keywords
- Belgium, Quality of hospital care, Rotavirus vaccination
- Medical subject headings
- Rotavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
The participating centre will be requested to generate a coded list of all hospitalisations taken place during the study period (June 1st 2004- May 31st 2010) and analysed for changes in hospital pattern pre- versus post-rotavirus vaccination, in children aged ≤15 years.
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized Group | Data collection for changes in hospital pattern pre- versus post-rotavirus vaccination, in children ≤15 years old hospitalised for any reason between June 2004 and May 2010. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of changes in hospitalisation pattern and workforce availability at the level of a pediatric ward in a hospital setting.
Measured: During the study period (from June 1st 2004 up to 6 years)
Secondary outcomes (4)
Expression of the changes into a quality of hospital care score that can be easily applied in different hospital settings.
Measured: During the study period (from June 1st 2004 up to 6 years)
Determination through factor and regression analysis which variable influences most the score in order to improve the score calculation.
Measured: During the study period (from June 1st 2004 up to 6 years)
Investigation of whether a change in the quality of hospital care score could be linked to the introduction of rotavirus vaccination.
Measured: During the study period (from June 1st 2004 up to 6 years)
Observation of other changes in the hospital organisation as a consequence of a change in the quality of hospital care score.
Measured: During the study period (from June 1st 2004 up to 6 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2012 (estimated)
- Study startDec 2013
- Primary completionSep 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infections, RotavirusStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01592838
- Sponsor's protocol ID
- 116721
- Status last verified
- Mar 2015
- First submitted
- 3 May 2012
- Last updated
- 1 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Pilot Study Assessing the Impact on the Quality of Hospital Care After the Introduction of Rotavirus Vaccination in Belgium
- ClinicalTrials.gov ID
- NCT01592838
- Acronym / sponsor ID
- 116721
- Conditions
- Infections, Rotavirus
- Keywords
- Belgium, Quality of hospital care, Rotavirus vaccination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 7 May 2012 (estimated)
- 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.
This study aims to investigate whether a change in the pattern of hospitalisation was observed in paediatric wards over the last 6 years (June 2004 - May 2010), whether a change in staff workforce availability was observed in paediatric wards over the last 6 years (during a whole year or during specific time periods of the year) and if changes of any of the variables measured during the observation period could be linked to the introduction of rotavirus vaccination.
Detailed description
This retrospective study will use data extracted from hospital databases during the period of the 1st of June 2004 until the 31st of May 2010. A coded list of all hospitalisations and of the different infection tests performed in children will be generated, together with a list of Full time equivalents (FTE) in paediatric ward and the number of sick leave days of the working personnel.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospitalized Group | – | Other: Data collectionData collection for changes in hospital pattern pre- versus post-rotavirus vaccination, in children ≤15 years old hospitalised for any reason between June 2004 and May 2010. |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children ≤15 years old hospitalised for any reason between June 2004 and May 2010.
Key inclusion criteria (1 listed)
- All children aged ≤15 years being hospitalised (with overnight stay or day clinic) for whatever reason during the study period
Key exclusion criteria (1 listed)
- Not Applicable
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 |
|---|---|---|
| Data collectionThe participating centre will be requested to generate a coded list of all hospitalisations taken place during the study period (June 1st 2004- May 31st 2010) and analysed for changes in hospital pattern pre- versus post-rotavirus vaccination, in children aged ≤15 years. | Other | Hospitalized Group |
Primary outcome
Determination of changes in hospitalisation pattern and workforce availability at the level of a pediatric ward in a hospital setting.
Time frame: During the study period (from June 1st 2004 up to 6 years)
4 secondary outcomes
Expression of the changes into a quality of hospital care score that can be easily applied in different hospital settings.
Time frame: During the study period (from June 1st 2004 up to 6 years)
Determination through factor and regression analysis which variable influences most the score in order to improve the score calculation.
Time frame: During the study period (from June 1st 2004 up to 6 years)
Investigation of whether a change in the quality of hospital care score could be linked to the introduction of rotavirus vaccination.
Time frame: During the study period (from June 1st 2004 up to 6 years)
Observation of other changes in the hospital organisation as a consequence of a change in the quality of hospital care score.
Time frame: During the study period (from June 1st 2004 up to 6 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Infections, Rotavirus, run by GlaxoSmithKline.
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: finished, as of the sponsor's last update on 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determination of changes in hospitalisation pattern and workforce availability at the level of a pediatric ward in a hospital setting. (time frame: During the study period (from June 1st 2004 up to 6 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2015.