Pediatric Patient Transfer to Adult Service:Transition ProgramEVATRANSENDNCT04277286
Evaluation of the TRANSEND Program
An observational study of Pediatric Patient Transfer to Adult Service:Transition Program, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 32 years
- Conditions the study is for
- Pediatric Patient Transfer to Adult Service:Transition Program
- What is being tested?
- survey
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 202 participants
- Where
- 1 siteFrance
- Study dates
- 9 Sep 2020to 10 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 32 years
- All sexes
- No healthy volunteers
- Adult
Study population: Young patients with endocrine or metabolic diseases
Who may be able to join
- 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
Who cannot join
- Patient who transferred to another adult service before being followed at Pitié-Salpêtrière
- Patient who has expressed his opposition to participate in this research
Trial locations and contacts
1 site in 1 country.
France1 site
Chef du Service d'Endocrinologie et Médecine de le Reproduction, Hôpital de la Pitié-Salpêtrière
Paris, 75013
About this study
Official title: 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.
Read the 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.
- Being tested
- survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surveyBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Patients transferred to adult service according to the Transend transition program (between September 2016 and January 2018) Receives: 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) Receives: Behavioral: survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months post transfert
Secondary outcomes (7)
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)
Measured: 24 to 36 months post transfert
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
Measured: 24 to 36 months post transfert
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)
Measured: 24 to 36 months post transfert
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
Measured: 24 to 36 months post transfet
Avoided care consumption and associated costs
Costs associated with hospital emergency room visits, home visit of SOS doctor, unplanned hospitalization
Measured: 24 to 36 months post transfret
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
Measured: 24 to 36 months post transfret
Assess Transend's efficiency
Cost/incremental cost-effectiveness ratio in cost gained and cost per loss of view
Measured: 24 to 36 months post transfret
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start9 Sep 2020
- Primary completion10 Oct 2020
- Study completion10 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Patient Transfer to Adult Service:Transition ProgramStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- TOURAINE Philippe, PU-PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277286
- Sponsor's protocol ID
- APHP190984
- Other IDs
- IDRCB 2019-A02243-54
- Acronym
- EVATRANSEND
- Status last verified
- Feb 2021
- First submitted
- 31 Jan 2020
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04277286
- Acronym / sponsor ID
- EVATRANSEND / APHP190984
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 10 Oct 2020 (actual)
- Study completion
- 10 Oct 2020 (actual)
- First posted
- 20 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Behavioral: surveyPatients transferred to adult service according to the Transend transition program (between September 2016 and January 2018) |
| Control group | – | Behavioral: surveyPatients transferred to adult service without a transition program, in the same center, before the implementation of Transend (between January 2015 and September 2016) |
Who may qualify
- Ages
- 18 to 32 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Young patients with endocrine or metabolic diseases
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Patient who transferred to another adult service before being followed at Pitié-Salpêtrière
- Patient who has expressed his opposition to participate in this research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surveyBehavioral 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) | Behavioural | Control group, Experimental group |
Primary outcome
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
7 secondary outcomes
Number of consultations not honored by the patient
Time frame: 24 to 36 months post transfert
Relationship of trust between caregiver and patient
Time frame: 24 to 36 months post transfert
Time to first consultation in adult medicine
Time frame: 24 to 36 months post transfert
Patient satisfaction
Time frame: 24 to 36 months post transfet
Avoided care consumption and associated costs
Time frame: 24 to 36 months post transfret
Compare the experience of the transition betmeen the two Groups
Time frame: 24 to 36 months post transfret
Assess Transend's efficiency
Time frame: 24 to 36 months post transfret
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TOURAINE Philippe, PU-PH principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Patient Transfer to Adult Service:Transition Program, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients lost to follow-up at 24 months post transfert (time frame: 24 months post transfert). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.