Evaluation of the TRANSEND Program (EVATRANSEND)

February 28, 2022 updated by: Assistance Publique - Hôpitaux de Paris

Non-randomized Experimental Study Evaluating the Impact of Implantation of a New Organization in the Adult Sector Intended to Improve the Transition of Young People With Endocrine or Metabolic Diseases

"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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
202

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75013
        • Chef du Service d'Endocrinologie et Médecine de le Reproduction, Hôpital de la Pitié-Salpêtrière

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 32 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Young patients with endocrine or metabolic diseases

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental group
Patients transferred to adult service according to the Transend transition program (between September 2016 and January 2018)
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)
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
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of patients lost to follow-up at 24 months post transfert
Time Frame: 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of consultations not honored by the patient
Time Frame: 24 to 36 months post transfert
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
Relationship of trust between caregiver and patient
Time Frame: 24 to 36 months post transfert

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
Time to first consultation in adult medicine
Time Frame: 24 to 36 months post transfert
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
Patient satisfaction
Time Frame: 24 to 36 months post transfet
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
Avoided care consumption and associated costs
Time Frame: 24 to 36 months post transfret
Costs associated with hospital emergency room visits, home visit of SOS doctor, unplanned hospitalization
24 to 36 months post transfret
Compare the experience of the transition betmeen the two Groups
Time Frame: 24 to 36 months post transfret
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
Assess Transend's efficiency
Time Frame: 24 to 36 months post transfret
Cost/incremental cost-effectiveness ratio in cost gained and cost per loss of view
24 to 36 months post transfret

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: TOURAINE Philippe, PU-PH, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 9, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 10, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 10, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • APHP190984
  • IDRCB 2019-A02243-54 (OTHER: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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