Determinants and Consequences of the Transition to Adulthood Among Adolescents With Haemophilia

NCT02866526 | Completed

• 1 other identifier: 2016-30
• Study Type: observational
• Target: 277
• Locations: 1 country
• Sites: 29

Brief Summary

Severe haemophilia is a rare disease characterized by spontaneous bleedings from early childhood, which may lead to various complications especially in joints. Due to advances in medical care and more specifically in the development of prophylactic strategies by the application of clotting factor concentrates, life expectancy of persons with severe haemophilia has significantly increased over the last decades. This progress requires a long-term follow-up, including into adulthood. The adherence to a regular clinical follow-up and to a prophylactic treatment then depends on how successful patients' transition from childhood to adulthood has been as this process involves a transfer of responsibility from parents to patients concerning the management of their health. Beyond the issue of patients' adherence, a suboptimal transition may also impair quality of life and the entry into adulthood, especially at the social, emotional and professional levels. Only a few studies have been conducted to identify the specific needs and difficulties young persons with severe haemophilia experience during their transition from childhood to adulthood, and none of these studies has been carried out in France where the features of the health care system are very specific. Therefore, this study aims to address the issue of transition into adulthood among young persons with severe haemophilia in France. This study will focus not only on the facilitators and barriers of the access to health care but also, from a more global perspective, on all the specific concerns and difficulties they may experience as they grow into adulthood which may impair their long-term health related quality of life as well as their personal empowerment. This study will also allow to identify some of the socio- cognitive, emotional, and familial determinants of a good transition into adulthood.

Conditions

Haemophilia

Keywords

adolescents; young adults

Outcome Measures

Primary Outcomes (2)

• Number of follow-up visits / theoretical number of follow-up visits over the last two years

  Adherence to clinical follow-up

  Two years

• Number of injections of prophylactic treatment realized / theoretical number of injections of prophylactic treatment over the last three months

  Adherence to prophylactic treatment

  3 months

Secondary Outcomes (3)

• Patient-reported adherence

  one day

• Physician-reported adherence of the patient

  one day

• Number of haemorrhagic events

  one day

Study Arms (2)

group1

adolescents (14-17 years old)

Other: Patient questionnaire

group 2

young adults (20-29 years old)

Other: Patient questionnaire

Interventions

Patient questionnaire OTHER

quantitative and qualitative data collection will be proposed.

group 2; group1

Eligibility Criteria

• Age: 14 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

cohort of persons with severe haemophilia

You may qualify if:

• Patients with severe haemophilia
• Patients enrolled in the FranceCoag national cohort
• Patients aged from 14 to 17 years old (adolescents group) or from 20 to 29 years old (young adults group)
• Adults patients having given their agreement to participate in the study, or minor patients authorized to participate in the study by their parents or their legal representatives

You may not qualify if:

• Patients with comprehension problems
• Patients unable to read or to write
• Adults patients not having given their agreement to participate in the study, or minor patients unauthorized to participate in the study by their parents or their legal representatives

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (29)

CHU D'Amiens

Amiens, 80054, France

Location

CHU de Besançon

Besançon, 25020, France

Location

CHU Bordeaux

Bordeaux, 33076, France

Location

Chu Brest

Brest, 29609, France

Location

CHU CAEN

Caen, 14033, France

Location

Ch Chambery

Chambéry, 73011, France

Location

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Chu Dijon

Dijon, 21034, France

Location

CHU Grenoble

Grenoble, 38043, France

Location

CH Versailles/ Le Chesnay

Le Chesnay, 78157, France

Location

Chu Lille

Lille, 59037, France

Location

CHU Limoges

Limoges, 87000, France

Location

Hospices Civiles de Lyon

Lyon, 69677, France

Location

Assistance Publique Hôpitaux de Marseille Hôpital de la Timone

Marseille, 13354, France

Location

CH Montmorency

Montmorency, 95160, France

Location

CHU Montpellier

Montpellier, 34295, France

Location

CHU Nancy

Nancy, 54511, France

Location

CHU Nantes

Nantes, 44093, France

Location

CHU Nice

Nice, 06202, France

Location

Assistance Publique Hôpitaux de Paris

Paris, 75015, France

Location

Assistance Publique Hôpitaux de Paris

Paris, 94275, France

Location

CHU Reims

Reims, 51092, France

Location

CHU Rennes

Rennes, 35000, France

Location

Chu Rouen

Rouen, 76031, France

Location

CHU Réunion

Saint-Denis, 97405, France

Location

CHU Saint-Etienne

Saint-Etienne, 42055, France

Location

CHU Strasbourg

Strasbourg, 67200, France

Location

CHU Toulouse

Toulouse, 31059, France

Location

CHU Tours

Tours, 37170, France

Location

Related Publications (1)

• Resseguier N, Rosso-Delsemme N, Beltran Anzola A, Baumstarck K, Milien V, Ardillon L, Bayart S, Berger C, Bertrand MA, Biron-Andreani C, Borel-Derlon A, Castet S, Chamouni P, Claeyssens Donadel S, De Raucourt E, Desprez D, Falaise C, Frotscher B, Gay V, Goudemand J, Gruel Y, Guillet B, Harroche A, Hassoun A, Huguenin Y, Lambert T, Lebreton A, Lienhart A, Martin M, Meunier S, Monpoux F, Mourey G, Negrier C, Nguyen P, Nyombe P, Oudot C, Pan-Petesch B, Polack B, Rafowicz A, Rauch A, Rivaud D, Schneider P, Spiegel A, Stoven C, Tardy B, Trossaert M, Valentin JB, Vanderbecken S, Volot F, Voyer-Ebrard A, Wibaut B, Leroy T, Sannie T, Chambost H, Auquier P. Determinants of adherence and consequences of the transition from adolescence to adulthood among young people with severe haemophilia (TRANSHEMO): study protocol for a multicentric French national observational cross-sectional study. BMJ Open. 2018 Jul 25;8(7):e022409. doi: 10.1136/bmjopen-2018-022409.

  PMID: 30049701 DERIVED

MeSH Terms

Conditions

Hemophilia A

Interventions

Patient Health Questionnaire

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Psychological Tests; Behavioral Disciplines and Activities; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Urielle DESALBRES

  ASSISTANCE Publique Hôpitaux de Marseille

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: August 15, 2016
• Study Start: February 13, 2017
• Primary Completion: February 27, 2019
• Study Completion: February 27, 2019
• Last Updated: February 14, 2023

Record last verified: 2023-02

Locations

FR (29)