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HaemophiliaTRANSHEMONCT02866526

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

An observational study of Haemophilia, run by Assistance Publique Hopitaux De Marseille at 29 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 14 to 29 years
Conditions the study is for
Haemophilia
What is being tested?
Patient questionnaire
How many people
277 participants
Where
29 sitesFrance
Study dates
13 Feb 2017to 27 Feb 2019
Phase
Observational
Are there results?
None posted in the registry

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 14 to 29 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: cohort of persons with severe haemophilia

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

France29 sites

  • CHU D'Amiens

    Amiens, 80054

  • CHU de Besançon

    Besançon, 25020

  • CHU Bordeaux

    Bordeaux, 33076

  • Chu Brest

    Brest, 29609

  • CHU CAEN

    Caen, 14033

  • Ch Chambery

    Chambéry, 73011

  • Chu Clermont-Ferrand

    Clermont-Ferrand, 63003

  • Chu Dijon

    Dijon, 21034

  • CHU Grenoble

    Grenoble, 38043

  • CH Versailles/ Le Chesnay

    Le Chesnay, 78157

  • Chu Lille

    Lille, 59037

  • CHU Limoges

    Limoges, 87000

  • Hospices Civiles de Lyon

    Lyon, 69677

  • Assistance Publique Hôpitaux de Marseille Hôpital de la Timone

    Marseille, 13354

  • CH Montmorency

    Montmorency, 95160

  • CHU Montpellier

    Montpellier, 34295

  • CHU Nancy

    Nancy, 54511

  • CHU Nantes

    Nantes, 44093

  • CHU Nice

    Nice, 06202

  • Assistance Publique Hôpitaux de Paris

    Paris, 75015

  • Assistance Publique Hôpitaux de Paris

    Paris, 94275

  • CHU Reims

    Reims, 51092

  • CHU Rennes

    Rennes, 35000

  • Chu Rouen

    Rouen, 76031

  • CHU Réunion

    Saint-Denis, 97405

  • CHU Saint-Etienne

    Saint-Etienne, 42055

  • CHU Strasbourg

    Strasbourg, 67200

  • CHU Toulouse

    Toulouse, 31059

  • CHU Tours

    Tours, 37170

Other trials in France

About this study

Official title: Determinants and Consequences of the Transition to Adulthood Among Adolescents With Haemophilia - TRANSHEMO

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.

Read the detailed 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.

Conditions
Haemophilia
Being tested
Patient questionnaire
Keywords
adolescents, young adults
Medical subject headings
Hemophilia A

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patient questionnaireOther

    quantitative and qualitative data collection will be proposed.

Study groups in NCT02866526
Study groupRoleWhat they receive
group1adolescents (14-17 years old)
Receives: Other: Patient questionnaire
group 2young adults (20-29 years old)
Receives: Other: Patient questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Adherence to clinical follow-up

    Measured: Two years

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

    Adherence to prophylactic treatment

    Measured: 3 months

Secondary outcomes (3)

  1. Patient-reported adherence

    Specific item of the patient questionnaire (0-10 points)

    Measured: one day

  2. Physician-reported adherence of the patient

    Specific item of the medical questionnaire (0-10 points)

    Measured: one day

  3. Number of haemorrhagic events

    Specific item of the medical questionnaire

    Measured: one day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2016 (estimated)
  2. Study start13 Feb 2017
  3. Primary completion27 Feb 2019
  4. Study completion27 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
277 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02866526
Sponsor's protocol ID
2016-30
Acronym
TRANSHEMO
Status last verified
Feb 2023
First submitted
4 Aug 2016
Last updated
14 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 30049701

Questions about this trial

What is this clinical trial studying?

An observational study of Haemophilia, run by Assistance Publique Hopitaux De Marseille at 29 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of follow-up visits / theoretical number of follow-up visits over the last two years (time frame: Two years). The study lists 2 primary outcomes in all. 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 NCT02866526, 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 14 Feb 2023.

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