Sickle Cell DiseaseDREPADONCT03786549
Pediatric -Adult Care Transition Program of Patients With Sickle Cell Disease
A study testing pediatric-adult care transition program in people with Sickle Cell Disease, run by Hospices Civils de Lyon at 8 sites in France.
Trial summary
Background The pediatric-adult care transition is a risk-disrupting time for patients with chronic disease. This care transition takes place during adolescence; a period of psychological upheavals and adaptations of family roles. Read more about this study
- Who is it for?
- Ages 16 to 17 years
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- pediatric-adult care transition program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 8 sitesFrance
- Study dates
- 16 Jan 2019to 16 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- For patients :
- Age: 16-17 years,
- With major sickle cell syndrome, defined by hemoglobinopathy of homozygosity SS, or double heterozygosity SC or Sβ-thalassemia,
- Benefiting from social insurance of the type "Affection of long duration" (ALD).
- For family members :
- Included children's parents or legal representatives,
- Accepting to participate in the study and having signed the informed consent.
Who cannot join
- Presenting a cognitive or psychiatric disorder known and major that may hinder interventions or evaluation, the judgment of the investigator, and / or having a family history with this type of disorders,
- Cured of SCD by an allograft of hematopoietic stem cells.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
France8 sites, 8 recruiting
- Not yet recruiting
Centre Hospitalier Intercommunal de Creteil
Créteil
Corinne Pondarre
Corinne Pondarre
- Not yet recruiting
Hôpital Mondor
Créteil
Frédéric Galactéros
Frédéric Galactéros
- Not yet recruiting
CHU de Fort de France
Fort-de-France-La Martinique, La Martinique
Gisèle ELANA, MD
Gisèle ELANA
- Not yet recruiting
Hôpital Bicêtre
Le Kremlin-Bicêtre
Corinne Guitton
Corinne Guitton
- Recruiting
Hospices Civils de Lyon
Lyon
Alexandra Gauthier- Vasserot
Giovanna Cannas
- Not yet recruiting
Hôpital Européen Georges Pompidou
Paris
Jean- Benoît Arlet
Jean- Benoît Arlet
- Not yet recruiting
Hôpital Necker
Paris
Marianne De Montalembert
Marianne De Montalembert
- Not yet recruiting
Centre Hospitalier de Pontoise
Pontoise
Stéphanie Eyssette- Guerreau
Stéphanie Eyssette- Guerreau
About this study
Official title: Impact of a Pediatric-adult Care Transition Program on the Health Status of Patients With Sickle Cell Disease - A Randomized Controlled Trial
Background The pediatric-adult care transition is a risk-disrupting time for patients with chronic disease. This care transition takes place during adolescence; a period of psychological upheavals and adaptations of family roles. During this period, medication adherence is non-optimal and absenteeism at medical appointments is high.
Sickle cell disease (SCD) is the first genetic disease detected in France. It is chronic disease characterized by frequent painful vaso-occlusive crises (VOC) requiring emergency hospitalization when they are severe. Other serious complications are acute chest syndromes (ACS) and stroke.
Read more
In order to improve the health status of teenagers with sickle cell disease, it is necessary to anticipate this care transition and to involve the pediatric and adult sectors. The biopsychosocial health approach and the Social-Ecological Model of Adolescent and Young Adult Readiness to Transition (SMART) describe a care transition integrating bioclinical and psychosocial factors such as integration of the patient's family, education on disease and therapeutics, psychological management of pain and medico-social orientation.
The pediatric-adult transition program proposed is based on this biopsychosocial approach. It aims to improve the health status of adolescents with SCD, their quality of life and the use of health care service.
Objective of the study To assess the impact of a pediatric-adult transition program on the incidence of sickle-cell-related complications leading to hospitalization on 24-months after transfer to the adult sector.
The evaluation focuses on severe complications leading to hospitalization, such as VOC, ACS, and stroke.
Study design Multicenter Open-label individual Randomized Controlled Trial Population : Patients aged at least 16 years old with sickle cell disease, and their parents (or legal representatives Number of subject : 196 patients (98 patients by arm) The study will last 24 months Expected results For patients and families Better health and quality of life for patients is expected, including better use of medical care after the transition program. It is also expected a better experience of the pediatric-adult care transition and indirectly a better experience of intrafamilial relations.
For health professionals This project is expected to provide solutions to improve the pediatric-adult care transition of patients with chronic disease. Indeed, the methodological quality of the study will make it possible to evaluate the efficiency of the proposed program, to possibly adapt it and test it to other chronic diseases presenting the same care transition problematic.
In terms of public health SCD mainly affects populations of sub-Saharan origin, with low visibility and high social vulnerability. By focusing on this population, this project will reduce the social inequalities in health, experienced by patients with SCD and their families.
By improving the health, quality of life and care of patients with SCD, this project is expected to decrease the cost of the pediatric-adult care transition period.
- Conditions
- Sickle Cell Disease
- Being tested
- pediatric-adult care transition program
- Keywords
- sickle cell disease (SDC), Pediatric-adult care transition
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pediatric-adult care transition programOther
Three structured axes of multidisciplinary interventions are added to the usual follow-up for the patients drawn in this interventional arm. Those axes integrate the bioclinical medical care and include the parents of the adolescent
Three axes are :
- Educative, family (patient and parent), at home
- Psychological, with the patient individually
- Medico-social orientation, group of patients
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients included in this arm wil have usual follow-up. |
| Care transitional program | Experimental | Patients included in this arm will get a care transitional program. Three structured axes of multidisciplinary interventions are added to the usual follow-up for the patients drawn in this interventional arm. Those axes integrate the bioclinical medical care and include the parents of the adolescent
Three axes are :
* Educative, family (patient and parent), at home
* Psychological, with the patient individually
* Medico-social orientation, group of patients Receives: Other: pediatric-adult care transition program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of sickle cell related severe complications leading to hospitalization
Number of hospital admission or emergency visit in the index hospital
Measured: Within 24 months after transfer to the adult sector
Secondary outcomes (35)
Frequency of emergency visits in the index hospital
Frequency of emergency visits in the index hospital Within inclusion and transfer to the adult sector
Measured: Up to 2 years
Frequency of emergency visits in the index hospital
Measured: Within 12 months after transfer to the adult sector
Frequency of emergency visits in the index hospital
Measured: Within 12 and 24 months after transfer to the adult sector
Medication Intake Survey-Asthma (MIS-A) questionnaire score
Medication adherence evaluation at inclusion
Measured: At inclusion
Medication Rating Scale (MARS) questionnaire score
Medication adherence evaluation at inclusion
Measured: At inclusion
MIS-A questionnaire score
Medication adherence evaluation At transfer to the adult sector
Measured: Up to 2 years
MARS questionnaire score
Medication adherence evaluation At transfer to the adult sector
Measured: Up to 2 years
MIS-A questionnaire score
Medication adherence evaluation within 12 months after transfer to the adult sector
Measured: within 12 months after transfer to the adult sector
MARS questionnaire score
This score will allow medication adherence evaluation within 12 months after transfer to the adult sector
Measured: within 12 months after transfer to the adult sector
MIS-A questionnaire score
Medication adherence evaluation within 24 months after transfer to the adult sector
Measured: within 24 months after transfer to the adult sector
MARS questionnaire score
Medication adherence evaluation within 24 months after transfer to the adult sector
Measured: within 24 months after transfer to the adult sector
Number of days absent at school
Scholarly Absenteeism evaluation At transfer to the adult sector
Measured: Up to 2 years
Number of days absent at school
Scholarly Absenteeism evaluation within 12 months after transfer to the adult sector
Measured: within 12 months after transfer to the adult sector
Number of days absent at school
Scholarly Absenteeism evaluation within 24 months after transfer to the adult sector
Measured: within 24 months after transfer to the adult sector
World Health Organization Quality of Life (WHOQOL) questionnaire score
Quality of Life evaluation At inclusion
Measured: At inclusion
WHOQOL questionnaire score
Quality of Life evaluation At transfer to the adult sector
Measured: Up to 2 years
WHOQOL questionnaire score
Quality of Life evaluation within 24 months after transfer to the adult sector
Measured: within 24 months after transfer to the adult sector
EUropean Health Literacy questionnaire (HLS-EU-Q16) score
This will allow Health Literacy evaluation
Measured: At inclusion
HLS-EU-Q16 score
Health Literacy evaluation At transfer to the adult sector
Measured: Up to 2 years
HLS-EU-Q16 score
Health Literacy evaluation within 24 months after transfer to the adult sector
Measured: within 24 months after transfer to the adult sector
Disease knowledge
Questionnaire developed for this study
Measured: At inclusion
Disease knowledge
Questionnaire developed for this study
Measured: Up to 2 years
Disease knowledge
Questionnaire developed for this study
Measured: within 24 months after transfer to the adult sector
Patient activation measure-13 items questionnaire score
Patient activation At inclusion
Measured: At inclusion
Patient activation measure-13 items questionnaire score
Patient activation At transfer to the adult sector
Measured: Up to 2 years
Patient activation measure-13 items questionnaire score
Patient activation within 24 months after transfer to the adult sector
Measured: within 24 months after transfer to the adult sector
Self efficacy specific instrument - sickle cell disease (SCD-SES) questionnaire score
Self efficacy evaluation at inclusion
Measured: At inclusion
SCD-SES questionnaire score
Self efficacy evaluation At transfer to the adult sector
Measured: Up to 2 years
SCD-SES questionnaire score
Self efficacy evaluation within 24 months after transfer to the adult sector
Measured: within 24 months after transfer to the adult sector
Transition readiness assessment questionnaire (TRAQ) questionnaire score
Transition readiness evaluation at inclusion
Measured: At inclusion
TRAQ questionnaire score
Transition readiness evaluation At transfer to the adult sector
Measured: Up to 2 years
TRAQ questionnaire score
Transition readiness evaluation within 24 months after transfer to the adult sector
Measured: within 24 months after transfer to the adult sector
cost effectiveness ratio
Cost analysis at the end of the study
Measured: Up to 4 years
number of pediatric-adult transition program sessions performed
number of interventions performed per patient and date of implementation At the end of the study
Measured: Up to 4 years
type of pediatric-adult transition program sessions performed
type of interventions performed per patient and date of implementation At the end of the study
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start16 Jan 2019
- Primary completion16 Apr 2027 (estimated)
- Study completion16 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03786549
- Sponsor's protocol ID
- 69HCL18_0039
- Other IDs
- 2018-A02198-47
- Acronym
- DREPADO
- Status last verified
- Jun 2024
- First submitted
- 13 Dec 2018
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hoegy D, Bleyzac N, Gauthier-Vasserot A, Cannas G, Denis A, Hot A, Bertrand Y, Occelli P, Touzet S, Dussart C, Janoly-Dumenil A; DREPADO study group. Impact of a paediatric-adult care transition programme on the health status of patients with sickle cell disease: study protocol for a randomised controlled trial (the DREPADO trial). Trials. 2020 Feb 10;21(1):152. doi: 10.1186/s13063-019-4009-9.
PubMed 32039737
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Pediatric-adult Care Transition Program on the Health Status of Patients With Sickle Cell Disease - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03786549
- Acronym / sponsor ID
- DREPADO / 69HCL18_0039
- Conditions
- Sickle Cell Disease
- Keywords
- sickle cell disease (SDC), Pediatric-adult care transition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 16 Jan 2019 (actual)
- Primary completion
- 16 Apr 2027 (estimated)
- Study completion
- 16 Apr 2027 (estimated)
- First posted
- 26 Dec 2018 (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.
Background The pediatric-adult care transition is a risk-disrupting time for patients with chronic disease. This care transition takes place during adolescence; a period of psychological upheavals and adaptations of family roles. During this period, medication adherence is non-optimal and absenteeism at medical appointments is high.
Sickle cell disease (SCD) is the first genetic disease detected in France. It is chronic disease characterized by frequent painful vaso-occlusive crises (VOC) requiring emergency hospitalization when they are severe. Other serious complications are acute chest syndromes (ACS) and stroke.
In order to improve the health status of teenagers with sickle cell disease, it is necessary to anticipate this care transition and to involve the pediatric and adult sectors. The biopsychosocial health approach and the Social-Ecological Model of Adolescent and Young Adult Readiness to Transition (SMART) describe a care transition integrating bioclinical and psychosocial factors such as integration of the patient's family, education on disease and therapeutics, psychological management of pain and medico-social orientation.
The pediatric-adult transition program proposed is based on this biopsychosocial approach. It aims to improve the health status of adolescents with SCD, their quality of life and the use of health care service.
Objective of the study To assess the impact of a pediatric-adult transition program on the incidence of sickle-cell-related complications leading to hospitalization on 24-months after transfer to the adult sector.
The evaluation focuses on severe complications leading to hospitalization, such as VOC, ACS, and stroke.
Study design Multicenter Open-label individual Randomized Controlled Trial Population : Patients aged at least 16 years old with sickle cell disease, and their parents (or legal representatives Number of subject : 196 patients (98 patients by arm) The study will last 24 months Expected results For patients and families Better health and quality of life for patients is expected, including better use of medical care after the transition program. It is also expected a better experience of the pediatric-adult care transition and indirectly a better experience of intrafamilial relations.
For health professionals This project is expected to provide solutions to improve the pediatric-adult care transition of patients with chronic disease. Indeed, the methodological quality of the study will make it possible to evaluate the efficiency of the proposed program, to possibly adapt it and test it to other chronic diseases presenting the same care transition problematic.
In terms of public health SCD mainly affects populations of sub-Saharan origin, with low visibility and high social vulnerability. By focusing on this population, this project will reduce the social inequalities in health, experienced by patients with SCD and their families.
By improving the health, quality of life and care of patients with SCD, this project is expected to decrease the cost of the pediatric-adult care transition period.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients included in this arm wil have usual follow-up. |
| Care transitional program | Experimental | Other: pediatric-adult care transition programPatients included in this arm will get a care transitional program. Three structured axes of multidisciplinary interventions are added to the usual follow-up for the patients drawn in this interventional arm. Those axes integrate the bioclinical medical care and include the parents of the adolescent Three axes are : * Educative, family (patient and parent), at home * Psychological, with the patient individually * Medico-social orientation, group of patients |
Who may qualify
- Ages
- 16 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age: 16-17 years,
- With major sickle cell syndrome, defined by hemoglobinopathy of homozygosity SS, or double heterozygosity SC or Sβ-thalassemia,
- Benefiting from social insurance of the type "Affection of long duration" (ALD).
- Included children's parents or legal representatives,
- Accepting to participate in the study and having signed the informed consent.
Key exclusion criteria (2 listed)
- Presenting a cognitive or psychiatric disorder known and major that may hinder interventions or evaluation, the judgment of the investigator, and / or having a family history with this type of disorders,
- Cured of SCD by an allograft of hematopoietic stem cells.
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 |
|---|---|---|
| pediatric-adult care transition programThree structured axes of multidisciplinary interventions are added to the usual follow-up for the patients drawn in this interventional arm. Those axes integrate the bioclinical medical care and include the parents of the adolescent Three axes are : * Educative, family (patient and parent), at home * Psychological, with the patient individually * Medico-social orientation, group of patients | Other | Care transitional program |
Primary outcome
Incidence of sickle cell related severe complications leading to hospitalization
Time frame: Within 24 months after transfer to the adult sector
Number of hospital admission or emergency visit in the index hospital
35 secondary outcomes
Frequency of emergency visits in the index hospital
Time frame: Up to 2 years
Frequency of emergency visits in the index hospital
Time frame: Within 12 months after transfer to the adult sector
Frequency of emergency visits in the index hospital
Time frame: Within 12 and 24 months after transfer to the adult sector
Medication Intake Survey-Asthma (MIS-A) questionnaire score
Time frame: At inclusion
Medication Rating Scale (MARS) questionnaire score
Time frame: At inclusion
MIS-A questionnaire score
Time frame: Up to 2 years
MARS questionnaire score
Time frame: Up to 2 years
MIS-A questionnaire score
Time frame: within 12 months after transfer to the adult sector
MARS questionnaire score
Time frame: within 12 months after transfer to the adult sector
MIS-A questionnaire score
Time frame: within 24 months after transfer to the adult sector
MARS questionnaire score
Time frame: within 24 months after transfer to the adult sector
Number of days absent at school
Time frame: Up to 2 years
Number of days absent at school
Time frame: within 12 months after transfer to the adult sector
Number of days absent at school
Time frame: within 24 months after transfer to the adult sector
World Health Organization Quality of Life (WHOQOL) questionnaire score
Time frame: At inclusion
WHOQOL questionnaire score
Time frame: Up to 2 years
WHOQOL questionnaire score
Time frame: within 24 months after transfer to the adult sector
EUropean Health Literacy questionnaire (HLS-EU-Q16) score
Time frame: At inclusion
HLS-EU-Q16 score
Time frame: Up to 2 years
HLS-EU-Q16 score
Time frame: within 24 months after transfer to the adult sector
Disease knowledge
Time frame: At inclusion
Disease knowledge
Time frame: Up to 2 years
Disease knowledge
Time frame: within 24 months after transfer to the adult sector
Patient activation measure-13 items questionnaire score
Time frame: At inclusion
Patient activation measure-13 items questionnaire score
Time frame: Up to 2 years
Patient activation measure-13 items questionnaire score
Time frame: within 24 months after transfer to the adult sector
Self efficacy specific instrument - sickle cell disease (SCD-SES) questionnaire score
Time frame: At inclusion
SCD-SES questionnaire score
Time frame: Up to 2 years
SCD-SES questionnaire score
Time frame: within 24 months after transfer to the adult sector
Transition readiness assessment questionnaire (TRAQ) questionnaire score
Time frame: At inclusion
TRAQ questionnaire score
Time frame: Up to 2 years
TRAQ questionnaire score
Time frame: within 24 months after transfer to the adult sector
cost effectiveness ratio
Time frame: Up to 4 years
number of pediatric-adult transition program sessions performed
Time frame: Up to 4 years
type of pediatric-adult transition program sessions performed
Time frame: Up to 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Derived from this study: PubMed 32039737Hoegy D, Bleyzac N, Gauthier-Vasserot A, Cannas G, Denis A, Hot A, Bertrand Y, Occelli P, Touzet S, Dussart C, Janoly-Dumenil A; DREPADO study group. Impact of a paediatric-adult care transition programme on the health status of patients with sickle cell disease: study protocol for a randomised controlled trial (the DREPADO trial). Trials. 2020 Feb 10;21(1):152. doi: 10.1186/s13063-019-4009-9.
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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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pediatric-adult care transition program in people with Sickle Cell Disease, run by Hospices Civils de Lyon at 8 sites 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 7 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: looking for participants now, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra GAUTHIER VASSEROT, DR (04 69 16 65 72 ext. +33, alexandra.gauthier@ihope.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of sickle cell related severe complications leading to hospitalization (time frame: Within 24 months after transfer to the adult sector). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03786549, which also lists 1 linked publication.
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 21 Jun 2024.