Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02866526 |
| Other study ID # |
2016-30 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 13, 2017 |
| Est. completion date |
February 27, 2019 |
Study information
| Verified date |
February 2023 |
| Source |
Assistance Publique Hopitaux De Marseille |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
The main objective of this study is to assess the impact of transition from adolescence into
adulthood especially on adherence to health care, among young people with severe haemophilia
in France.
The operational objectives of this study are: i) to compare the level of adherence in
adolescents and in young adults (YA) ii) to identify determinants (medical, organisational,
socio-demographic and social, and psychosocial and behavioural factors) of the level of
adherence in YPWH (young people with haemophilia), iii) to assess specific factors involved
in suboptimal level of adherence in the sub-groups of adolescents on one hand and of YA on
the other hand, iv) to identify groups of patients (clusters) regarding both their level of
adherence and their psychosocial characteristics, v) to examine trough a qualitative approach
YPWH needs and expectations towards the health care system during the transition process, and
to identify some ways to improve their global care.
This study is an exploratory, observational, multicentric, transversal study aimed at
describing the perceptions of adolescents (14-17 years old) with severe haemophilia to those
of young adults (20-29 years old) regarding their expectations and their feelings about
growing into adulthood. Every patient enrolled in the FranceCoag national cohort (cohort of
French patients suffering from inherited deficiencies of coagulation proteins), suffering
from severe haemophilia, aged from 14 to 17 years old or from 20 to 29 years old, will be
offered to get enrolled in the TRANSHEMO study (expected number eligible of participants: 154
adolescents and 389 young adults). , among whom 70% are expected to take part in the study).
The patients' participation in this study will not modify their medical or paramedical care.
A multifocal approach which combines both quantitative and qualitative data collection will
be proposed.
