NCT04277286

Brief Summary

"Transend" is a program designed to promote the transition of young patients with endocrine or metabolic diseases when they arrive in the adult sector at La Pitié-Salpétrière hospital. The main objective of the study is to compare the rate of patients lost to follow-up at 24 months after the transfer of pediatrics between the Transend group and the (historical) control group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

September 9, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2020

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2021

Enrollment Period

1 month

First QC Date

January 31, 2020

Last Update Submit

February 28, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rate of patients lost to follow-up at 24 months post transfert

    Defined by pathology as patients who have not been seen in a medical consultation since a time superior of the recommendation for his state of Heath at 24 months post-transfer and for whom no elements confirm a next consultation in the center nor a follow-up in another center

    24 months post transfert

Secondary Outcomes (7)

  • Number of consultations not honored by the patient

    24 to 36 months post transfert

  • Relationship of trust between caregiver and patient

    24 to 36 months post transfert

  • Time to first consultation in adult medicine

    24 to 36 months post transfert

  • Patient satisfaction

    24 to 36 months post transfet

  • Avoided care consumption and associated costs

    24 to 36 months post transfret

  • +2 more secondary outcomes

Study Arms (2)

Experimental group

Patients transferred to adult service according to the Transend transition program (between September 2016 and January 2018)

Behavioral: survey

Control group

Patients transferred to adult service without a transition program, in the same center, before the implementation of Transend (between January 2015 and September 2016)

Behavioral: survey

Interventions

surveyBEHAVIORAL

Behavioral study of patients who are in the "Transend" Program (compliance in follow-up visits after transfert from pediatric to adult care in the 24 months)

Control groupExperimental group

Eligibility Criteria

Age18 Years - 32 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Young patients with endocrine or metabolic diseases

You may qualify if:

  • Patient aged 18 to 32
  • Patient with endocrine or metabolic disease
  • Patient who had a follow-up in a pediatric department for his endocrine or metabolic disease
  • Patient transferred to the adult sector in the endocrinology, metabolism or nutrition department of Pitié-Salpêtrière
  • Patient who had a first post-transfer consultation between January 1, 2015 and September 1, 2017
  • Patient with a social security protection

You may not qualify if:

  • Patient who transferred to another adult service before being followed at Pitié-Salpêtrière
  • Patient who has expressed his opposition to participate in this research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chef du Service d'Endocrinologie et Médecine de le Reproduction, Hôpital de la Pitié-Salpêtrière

Paris, 75013, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • TOURAINE Philippe, PU-PH

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2020

First Posted

February 20, 2020

Study Start

September 9, 2020

Primary Completion

October 10, 2020

Study Completion

October 10, 2020

Last Updated

March 2, 2022

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations