Impact of Spa Treatments on the Consumption of Care in Children

NCT03931226 | Completed

• 1 other identifier: RC31/18/0420
• Study Type: observational
• Target: 8,372
• Locations: 1 country
• Sites: 1

Brief Summary

Children represent 1.2% of the spa population in France. Spa treatments, including climatic stays, are mainly prescribed for children in the context of respiratory, otorhinolaryngology and dermatological conditions. The benefits after spa treatments are the improvement of the symptoms of the pathology, the quality of life and in particular the reduction of drug exposures. Few authors have recently investigated the impact of spa treatments on the health of children and society, while care has changed significantly in recent years. Moreover, no real-life study of a large sample of children seems to have been conducted in this area. The present study plan to conduct a pharmacoepidemiology study on medico-administrative databases of the "observational study" type, in real life.

Conditions

Respiratory Disease; Otorhinolaryngologic Diseases; Dermatologic Disease

Keywords

drug consumption

Outcome Measures

Primary Outcomes (1)

• Drug consumption

  number of Daily Defined Doses (DDDs)

  until 7 years-old of children

Secondary Outcomes (5)

• Description of spa treatment

  until 7 years-old of children

• Population of children

  until 7 years-old of children

• Compare 2 data sources

  until 7 years-old of children

• impact of SPA treatment on the pathology

  until 7 years-old of children

• Medical costs

  until 7 years-old of children

Study Arms (2)

Departmental cohort

Department level of the Haute-Garonne through the use of the 'POMME' cohort (PrescriptiOns Medicines Mother Children)

Drug: Drug consumption

National cohort

National level through the use of the "EGB" database (General Sample of Beneficiaries)

Drug: Drug consumption

Interventions

Drug consumption DRUG

number of Daily Defined Doses (DDDs) of medications prescribed and given to children in connection with the indication of the spa treatment

Departmental cohort; National cohort

Eligibility Criteria

• Age: 1 Year - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

This pharmacoepidemiology study of the "observational study" type, in real life, will concern children aged 1 to 15 living in France at the time of the study. It will be conducted at the departmental level of the Haute-Garonne through the use of the APPLE database (PrescriptiOns Medicines Mother Children) and at the national level through the use of the database. EGB (General Sample of Beneficiaries).

You may qualify if:

• Children living in France at the time of the study
• 'POMME' cohort : children included at birth and 'EGB' cohort : children from birth to 15 years-old

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital Toulouse

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Respiration Disorders; Otorhinolaryngologic Diseases; Skin Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Skin and Connective Tissue Diseases

Study Officials

• Agnès Sommet, MD PhD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: April 30, 2019
• Study Start: June 1, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)