SO-FIT
Research type
Research Study
Full title
SO-FIT Study Of physical Function In adolescenTs with haemophilia
IRAS ID
130951
Contact name
K Khair
Contact email
Sponsor organisation
Haemnet
Research summary
Haemophilia is a bleeding disorder, affecting boys causing internal bleeding into the joints. Treatment is given, as an intra-venous injection every other day to prevent bleeding, thus most boys in the UK are growing up with apparently normal joint function and ability. Healthcare commissioners are increasingly demanding outcome measures to ‘prove’ the effectiveness of treatment and to justify continued treatment. Several tools are available to assess joint health; these include patient self-reported questionnaires and health care provider joint assessment.
The study aims to explore whether functional ability and quality of life (QoL) reported by boys with haemophilia correlate with joint scores as measured by the Haemophilia Joint Health Score in children and young people aged 8-16 years with severe haemophilia.
The study will ask 120 boys, treated at sixteen UK haemophilia centres, to complete questionnaires to describe their day-to-day functional ability using three validated questionnaires that are routinely used as outcome measures in haemophilia care. These questionnaires are used to ‘prove’ that intensive haemophilia treatment promotes good joint health and limits functional disability.
These paper and pencil questionnaires are not popular with young people; they are lengthy and tedious to complete. In this study we are asking boys about their preference in completing these questionnaires on paper or electronically on a tablet computer.
HJHS scores are routinely performed in boys with haemophilia to monitor their joint health. This study aims to compare the subjective functional assessments against the standardized joint scores. Two assessments of functional ability and HJHS will be performed over a six month period; one with paper questionnaires and one using a tablet computer. The haemophilia centres will be randomized to either paper or computer questionnaires at the first visit; the second visit will be crossed over so that all boys will complete one paper and one computer questionnaire.
REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
13/LO/1733
Date of REC Opinion
19 Nov 2013
REC opinion
Further Information Favourable Opinion