Valuation of Quality of Life in Children With Asthma | NCT00491101

Studies
Valuation of Quality of Life in Children With Asthma

NCT00491101

Sponsor

Medical University of Lodz

Status

Completed

Last Update Posted

Sep 13, 2010Estimated

Enrollment

110Actual

Phase

Not provided

Conditions

Asthma

Interventions

Polish Version of PAQLQ(S) by Juniper
spirometry

Countries

Poland

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

Dec 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Oct 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

Jun 22, 2007

First Submission Date that Met QC Criteria

Jun 22, 2007

First Posted Date

Jun 25, 2007Estimated

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

Sep 10, 2010

Last Update Posted Date

Sep 13, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The aim of the study is valuation of quality of life (QL) in children with asthma and analysis of the factors that can have influence on it. The clinical problems included into the aim are to evaluate:

the correlation between the QL and asthma control
the utility of the Polish Version of PAQLQ(S) by Juniper, especially the understanding of each question and it's answers The results of this study can be very helpful in the future in developing a questionnaires to use in Polish Primary Care, according to which the investigators would be able to see whether the asthma in our patients is being well controlled.

Detailed Description

Quality of Life in people with asthma is strictly relevant with the correct treatment of the disease, that is why the correct screening of patient's quality of life, especially in children, is so important.

Exploring the quality of life (QL), we use different types of questionnaires to obtain a quantitative result, which we can interpret using a compatible key for it. Pediatric Asthma Quality of Life Questionnaire with Standardized Activities (PAQLQ(S)) by Juniper is a reliable measure of the influence of asthma on QL in children. The Polish Version of the questionnaire is a strict translation of the english one, however it is not completely validated, which in practice can evince in difficulties in understanding the meaning of the applied questions, probably because of the difference in the habits of both populations.

the correlation between the QL and asthma control
the utility of the Polish Version of PAQLQ(S) by Juniper, especially the understanding of each question and it's answers The results of this study can be very helpful in the future in developing a questionnaires to use in Polish Primary Care, according to which we would be able to see whether the asthma in our patients is being well controlled.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

110Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Children with asthma, both genders, from 7-18 years old.	Other: Polish Version of PAQLQ(S) by Juniper Other: spirometry

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Polish Version of PAQLQ(S) by Juniper	Other	Polish Version of PAQLQ(S) by Juniper	1

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of Asthma
Asthma treatment at least 6 months before enrollment
Must be able to do spirometry

Exclusion Criteria:

Children during the introductory period of the specific immunotherapy
Other protracted diseases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Children with asthma.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Iwona Stelmach, MD, PhD, Prof	Department of Pediatrics and Allergy, Medical University of Lodz, Poland	Study Chair
Daniela Gjurow, MD	Department of Pediatrics and Allergy, Medical University of Lodz, Poland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Pediatrics and Allergy, Medical University of Lodz, Poland		Lodz		93-513	Poland

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

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Browse Branches

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