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Trial record 6 of 696 for:    sickle cell disease

Pediatric -Adult Care Transition Program of Patients With Sickle Cell Disease (DREPADO)

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ClinicalTrials.gov Identifier: NCT03786549
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Sickle Cell Disease Other: pediatric-adult care transition program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Impact of a Pediatric-adult Care Transition Program on the Health Status of Patients With Sickle Cell Disease - A Randomized Controlled Trial
Actual Study Start Date : January 16, 2019
Estimated Primary Completion Date : January 16, 2023
Estimated Study Completion Date : January 16, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
Patients included in this arm wil have usual follow-up.
Experimental: Care transitional program

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
Other: pediatric-adult care transition 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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Frequency of emergency visits in the index hospital [ Time Frame: Up to 2 years ]
    Frequency of emergency visits in the index hospital Within inclusion and transfer to the adult sector

  2. Frequency of emergency visits in the index hospital [ Time Frame: Within 12 months after transfer to the adult sector ]
  3. Frequency of emergency visits in the index hospital [ Time Frame: Within 12 and 24 months after transfer to the adult sector ]
  4. Medication Intake Survey-Asthma (MIS-A) questionnaire score [ Time Frame: At inclusion ]
    Medication adherence evaluation at inclusion

  5. Medication Rating Scale (MARS) questionnaire score [ Time Frame: At inclusion ]
    Medication adherence evaluation at inclusion

  6. MIS-A questionnaire score [ Time Frame: Up to 2 years ]
    Medication adherence evaluation At transfer to the adult sector

  7. MARS questionnaire score [ Time Frame: Up to 2 years ]
    Medication adherence evaluation At transfer to the adult sector

  8. MIS-A questionnaire score [ Time Frame: within 12 months after transfer to the adult sector ]
    Medication adherence evaluation within 12 months after transfer to the adult sector

  9. MARS questionnaire score [ Time Frame: within 12 months after transfer to the adult sector ]
    This score will allow medication adherence evaluation within 12 months after transfer to the adult sector

  10. MIS-A questionnaire score [ Time Frame: within 24 months after transfer to the adult sector ]
    Medication adherence evaluation within 24 months after transfer to the adult sector

  11. MARS questionnaire score [ Time Frame: within 24 months after transfer to the adult sector ]
    Medication adherence evaluation within 24 months after transfer to the adult sector

  12. Number of days absent at school [ Time Frame: Up to 2 years ]
    Scholarly Absenteeism evaluation At transfer to the adult sector

  13. Number of days absent at school [ Time Frame: within 12 months after transfer to the adult sector ]
    Scholarly Absenteeism evaluation within 12 months after transfer to the adult sector

  14. Number of days absent at school [ Time Frame: within 24 months after transfer to the adult sector ]
    Scholarly Absenteeism evaluation within 24 months after transfer to the adult sector

  15. World Health Organization Quality of Life (WHOQOL) questionnaire score [ Time Frame: At inclusion ]
    Quality of Life evaluation At inclusion

  16. WHOQOL questionnaire score [ Time Frame: Up to 2 years ]
    Quality of Life evaluation At transfer to the adult sector

  17. WHOQOL questionnaire score [ Time Frame: within 24 months after transfer to the adult sector ]
    Quality of Life evaluation within 24 months after transfer to the adult sector

  18. EUropean Health Literacy questionnaire (HLS-EU-Q16) score [ Time Frame: At inclusion ]
    This will allow Health Literacy evaluation

  19. HLS-EU-Q16 score [ Time Frame: Up to 2 years ]
    Health Literacy evaluation At transfer to the adult sector

  20. HLS-EU-Q16 score [ Time Frame: within 24 months after transfer to the adult sector ]
    Health Literacy evaluation within 24 months after transfer to the adult sector

  21. Disease knowledge [ Time Frame: At inclusion ]
    Questionnaire developed for this study

  22. Disease knowledge [ Time Frame: Up to 2 years ]
    Questionnaire developed for this study

  23. Disease knowledge [ Time Frame: within 24 months after transfer to the adult sector ]
    Questionnaire developed for this study

  24. Patient activation measure-13 items (PAM-13) questionnaire score [ Time Frame: At inclusion ]
    Patient activation At inclusion

  25. PAM-13 questionnaire score [ Time Frame: Up to 2 years ]
    Patient activation At transfer to the adult sector

  26. PAM-13 questionnaire score [ Time Frame: within 24 months after transfer to the adult sector ]
    Patient activation within 24 months after transfer to the adult sector

  27. Self efficacy specific instrument - sickle cell disease (SCD-SES) questionnaire score [ Time Frame: At inclusion ]
    Self efficacy evaluation at inclusion

  28. SCD-SES questionnaire score [ Time Frame: Up to 2 years ]
    Self efficacy evaluation At transfer to the adult sector

  29. SCD-SES questionnaire score [ Time Frame: within 24 months after transfer to the adult sector ]
    Self efficacy evaluation within 24 months after transfer to the adult sector

  30. Transition readiness assessment questionnaire (TRAQ) questionnaire score [ Time Frame: At inclusion ]
    Transition readiness evaluation at inclusion

  31. TRAQ questionnaire score [ Time Frame: Up to 2 years ]
    Transition readiness evaluation At transfer to the adult sector

  32. TRAQ questionnaire score [ Time Frame: within 24 months after transfer to the adult sector ]
    Transition readiness evaluation within 24 months after transfer to the adult sector

  33. cost effectiveness ratio [ Time Frame: Up to 4 years ]
    Cost analysis at the end of the study

  34. number of pediatric-adult transition program sessions performed [ Time Frame: Up to 4 years ]
    number of interventions performed per patient and date of implementation At the end of the study

  35. type of pediatric-adult transition program sessions performed [ Time Frame: Up to 4 years ]
    type of interventions performed per patient and date of implementation At the end of the study



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786549


Contacts
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Contact: Yves BERTRAND, Pr 04 69 16 65 88 ext +33 yves.bertrand@chu-lyon.fr
Contact: Sandrine TOUZET, Dr 04 72 11 57 61 ext +33 sandrine.touzet@chu-lyon.fr

Locations
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France
Centre Hospitalier Intercommunal de Creteil Not yet recruiting
Créteil, France
Contact: Corinne Pondarre         
Principal Investigator: Corinne Pondarre         
Hôpital Mondor Not yet recruiting
Créteil, France
Contact: Frédéric Galactéros         
Principal Investigator: Frédéric Galactéros         
Centre Hospitalier Universitaire de Grenoble Not yet recruiting
Grenoble, France
Contact: Corinne Armari-Alla         
Principal Investigator: Corinne Armari-Alla         
Principal Investigator: Caroline Makowsky         
Hôpital Bicêtre Not yet recruiting
Le Kremlin-Bicêtre, France
Contact: Corinne Guitton         
Principal Investigator: Corinne Guitton         
Principal Investigator: Christelle Chantalat         
Hospices Civils de Lyon Recruiting
Lyon, France
Contact: Alexandra Gauthier- Vasserot         
Contact: Giovanna Cannas         
Principal Investigator: Alexandra Gauthier- Vasserot         
Principal Investigator: Giovanna Cannas         
Hôpital Européen Georges Pompidou Not yet recruiting
Paris, France
Contact: Jean- Benoît Arlet         
Principal Investigator: Jean- Benoît Arlet         
Hôpital Necker Not yet recruiting
Paris, France
Contact: Marianne De Montalembert         
Principal Investigator: Marianne De Montalembert         
Centre Hospitalier de Pontoise Not yet recruiting
Pontoise, France
Contact: Stéphanie Eyssette- Guerreau         
Principal Investigator: Stéphanie Eyssette- Guerreau         
Principal Investigator: Laurent Blum         
Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03786549     History of Changes
Other Study ID Numbers: 69HCL18_0039
2018-A02198-47 ( Other Identifier: ID RCB Number )
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
sickle cell disease (SDC)
Pediatric-adult care transition
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn