NCT03299699

Completed

Quality of Life and Adjustment Among Siblings of Children an...

Assistance Publique Hopitaux De Marseille Source

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Other study identifiers

Sponsor study identifier

2017-06

Study Type

observational

Actual enrollment (reported)

30

Locations

1 country

Sites

1

Timeline

Study Start

March 15, 2020

Actual (reported)

Primary Completion

May 1, 2021

Actual (reported)

Study Completion

May 1, 2021

Actual (reported)

Brief Summary

Severe hemophilia is a rare and chronic disease characterized by spontaneous bleedings from early childhood, which may lead to various complications especially in joints. The diagnosis of this disease, but also its long term care have an impact on the relatives of the affected persons, including the siblings who bear daily the cognitive, emotional and social impacts of the disease. Studies conducted in the framework of pediatric chronic diseases showed that siblings of affected children presented a higher prevalence of physical and psychological troubles (emotional distress, behavioral disorders, etc.) than siblings who were not concerned by a disease. Few studies have been conducted in the framework of severe hemophilia, and to our knowledge, no study addresses this issue in France.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 30 participants
Study completion date: May 1, 2021
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
September 28, 2017
Actual (reported)
First Posted
October 3, 2017
Actual (reported)
Study Start
March 15, 2020
Actual (reported)
Primary Completion
May 1, 2021
Actual (reported)
Study Completion
May 1, 2021
Actual (reported)

Last Updated: June 8, 2023
Status Verified: June 2023
Last Update Submitted: June 7, 2023

Conditions

Severe Haemophilia

Outcome Measures

Primary Outcomes (1)

Global quality of life
Kidscreen 10 Index, is a self-report measure, consisting of 10 items that are scored on a fivepoint scale, ranging from 1 (not at all/never) to 5 (extremely/ never)
one day

Secondary Outcomes (3)

Emotional adjustment
one day
Coping strategies use
one day
Social support
one day

Eligibility Criteria

Age8 Years - 18 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

Sampling MethodNon-Probability Sample

Study Population

siblings of children and adolescents with severe hemophilia

You may qualify if:

Sibling (brother, sister, half-brother or half-sister) of older children or adolescents included in the TRANSHEMO study, who lives in the same home)

Sponsors & Collaborators

Assistance Publique Hopitaux De Marseille
Otherlead

Study Sites (1)

Hôpital de la Timone Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

Urielle Desalbres
Assistance Publique Hôpitaux de Marseille
STUDY DIRECTOR

Enrollment

30 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 28, 2017

First Posted

October 3, 2017

Study Start

March 15, 2020

Actual (reported)

Sibling aged 8-18 years old

Sibling affiliated to the French social security system

Sibling whose parents are not opposed to the participation in the study

You may not qualify if:

Sibling (brother, sister, half-brother or half-sister) of older children or adolescents who are not included in the TRANSHEMO study)
Sibling aged under 8 or over 18 years old
Sibling not affiliated to the French social security system
Sibling whose parents are opposed to the participation in the study
Sibling with difficulties reading and writing
Sibling with learning disabilities

Contact the study team to confirm eligibility.

Primary Completion

May 1, 2021

Actual (reported)

Study Completion

May 1, 2021

Actual (reported)

Last Updated

June 8, 2023

Record last verified: 2023-06

Source record

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Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03299699
Data provider: ClinicalTrials.gov
Source updated: 2023-06-08
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:34:28 UTC

Locations

FR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations