Program to help teenagers with sickle cell disease transition to adult care
Impact of a Pediatric-adult Care Transition Program on the Health Status of Patients With Sickle Cell Disease - A Randomized Controlled Trial
This study tests a program designed to help teenagers with sickle cell disease smoothly move from children's healthcare to adult care by providing both medical and emotional support.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 196 (estimated) |
| Ages | 16 Years to 17 Years |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 8 sites (Fort-de-France-La Martinique, La Martinique and 7 other locations) |
| Trial ID | NCT03786549 on ClinicalTrials.gov |
What this trial studies
This program aims to improve the transition of care for adolescents with sickle cell disease as they move from pediatric to adult healthcare services. It addresses the challenges faced during this critical period, including medication adherence and appointment attendance. By utilizing a biopsychosocial health approach and the Social-Ecological Model of Adolescent and Young Adult Readiness to Transition (SMART), the program integrates both clinical and psychosocial support to enhance health outcomes. The intervention involves collaboration between pediatric and adult healthcare sectors to ensure a smoother transition for patients.
Who should consider this trial
Good fit: Ideal candidates for this program are adolescents aged 16-17 years with major sickle cell syndrome.
Not a fit: Patients who have undergone a hematopoietic stem cell transplant or have significant cognitive or psychiatric disorders may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could significantly improve health outcomes and quality of life for teenagers with sickle cell disease during their transition to adult care.
How similar studies have performed: Other studies have shown success in improving care transitions for chronic diseases, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Fort-de-France-La Martinique, La Martinique and 7 other locations
- CHU de Fort de France — Fort-de-France-La Martinique, La Martinique, France (Not_yet_recruiting)
- Centre Hospitalier Intercommunal de Creteil — Créteil, France (Not_yet_recruiting)
- Hôpital Mondor — Créteil, France (Not_yet_recruiting)
- Hôpital Bicêtre — Le Kremlin-Bicêtre, France (Not_yet_recruiting)
- Hospices Civils de Lyon — Lyon, France (Recruiting)
- Hôpital Européen Georges Pompidou — Paris, France (Not_yet_recruiting)
- Hôpital Necker — Paris, France (Not_yet_recruiting)
- Centre Hospitalier de Pontoise — Pontoise, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Alexandra GAUTHIER VASSEROT, DR
- Email: alexandra.gauthier@ihope.fr
- Phone: 04 69 16 65 72
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.