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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04277286
Other study ID # APHP190984
Secondary ID IDRCB 2019-A0224
Status Completed
Phase
First received
Last updated
Start date September 9, 2020
Est. completion date October 10, 2020

Study information

Verified date February 2021
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Adolescence and early adulthood represent important periods for young people suffering from chronic diseases. Several observational studies show needs not covered by care services at this period and significant lost to follow-up rates. "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 (Paris, France). Since September 1, 2016, approximately 500 patients benefited from it.


Recruitment information / eligibility

Status Completed
Enrollment 202
Est. completion date October 10, 2020
Est. primary completion date October 10, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 32 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Patient who transferred to another adult service before being followed at Pitié-Salpêtrière - Patient who has expressed his opposition to participate in this research

Study Design


Related Conditions & MeSH terms

  • Pediatric Patient Transfer to Adult Service:Transition Program

Intervention

Behavioral:
survey
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)

Locations

Country Name City State
France Chef du Service d'Endocrinologie et Médecine de le Reproduction, Hôpital de la Pitié-Salpêtrière Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Number of consultations not honored by the patient Experimental group: patients transferred to adult service according to the Transend transition program (between September 2016 and January 2018) Control group: patients transferred to adult service without a transition program, in the same center, before the implementation of Traansend (between January 2015 and September 2016) 24 to 36 months post transfert
Secondary Relationship of trust between caregiver and patient Score calculated by wake Forest scaleis a validated scale of 10 items for the evaluation of the different components of trust.including 3 items on loyalty, 3 items on competence, 1 item on honesty and 3 items on global trust.
(short version) resulting from an evaluation anonymously made by patients
24 to 36 months post transfert
Secondary Time to first consultation in adult medicine Experimental group: patients transferred to adult service according to the Transend transition program (between September 2016 and January 2018) Control group: patients transferred to adult service without a transition program, in the same center, before the implementation of Traansend (between January 2015 and September 2016) 24 to 36 months post transfert
Secondary Patient satisfaction Satisfaction collected on a scale of 0 to 10 where 0 means the worst transfer imaginable resulting an anonymous assessment carried out by the Patients 24 to 36 months post transfet
Secondary Avoided care consumption and associated costs Costs associated with hospital emergency room visits, home visit of SOS doctor, unplanned hospitalization 24 to 36 months post transfret
Secondary Compare the experience of the transition betmeen the two Groups Frequency of feeling broken, continuity, need to contact the paediatrician, attention and perceived availability on the part of professionals on arrival in the adult hospital 24 to 36 months post transfret
Secondary Assess Transend's efficiency Cost/incremental cost-effectiveness ratio in cost gained and cost per loss of view 24 to 36 months post transfret