Transition From Pediatric to Adult Cystic Fibrosis Care Center

NCT02790879 | Unknown

• 1 other identifier: 69HCL15_0629
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of register-SAFETIM is to assess the impact of the transition from pediatric to adult cystic fibrosis care center on changes in lung function and nutritional status of patients. This is a multicenter, observational, longitudinal, with analysis of the French national registry data of patients with cystic fibrosis. Our study will assess the clinical features of adolescent patients with cystic fibrosis during the transition from pediatric care to adult care. It will explore factors associated with the impact of the transition on the clinical course of adolescent patients (respiratory and nutritional functions).

Conditions

Cystic Fibrosis

Keywords

Transitional care; teenagers; cystic fibrosis; pulmonary function; nutritional function; Patients who experiment a transition pediatric - adult care

Outcome Measures

Primary Outcomes (1)

• Changes in FEV (FEV is the slope expressed in percentage of the predicted value).

  Two years

Secondary Outcomes (4)

• Body Mass Index (BMI)

  Two years

• Pseudomonas aeruginosa colonization

  Two years

• External pancreatic insufficiency

  Two years

• Diabetes

  Two years

Study Arms (1)

Transition

Patients who switched from pediatric cystic fibrosis care center to an adult cystic fibrosis care center during 2013 or 2014, regardless of their clinical status.

Other: Transition pediatric - adult

Interventions

Transition pediatric - adult OTHER

Transition

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who switched from pediatric cystic fibrosis care center to an adult cystic fibrosis care center during 2013 or 2014, regardless of their clinical status

You may qualify if:

• \- patients who switched from pediatric cystic fibrosis care center to an adult cystic fibrosis care center during 2013 or 2014, regardless of their clinical status.

You may not qualify if:

• \- Patients whose transition year is not given in the French national register, that is to say patients from some mixed care center.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Pôle Information Médicale, Evaluation, Recherche 162 avenue Lacassagne - Bâtiment A

Lyon, Auvergne-Rhône-Alpes, 69424, France

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Transition to Adult Care

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Sandrine TOUZET, MD

  Hospices Civils de Lyon, Pôle Information Médicale, Evaluation, Recherche

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stéphanie POUPON-BOURDY

CONTACT

(0)4 72 11 54 16; stephanie.poupon-bourdy@chu-lyon.fr

Sandrine TOUZET, MD

CONTACT

(0)4 72 11 51 62; sandrine.touzet@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2016
• First Posted: June 6, 2016
• Study Start: October 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: June 6, 2016

Record last verified: 2016-05

Locations

FR (1)