Validation of two measures for growth hormone deficiency in children
Research type
Research Study
Full title
Validation of two measures for growth hormone deficiency in children, the Treatment Related Impact Measure of Childhood Growth Hormone Deficiency (TRIM-CGHD) and the Treatment Burden Measure of Childhood Growth Hormone Deficiency (TB-CGHD)
IRAS ID
219425
Contact name
Joanne C Blair
Contact email
Sponsor organisation
Novo Nordisk A/S
Clinicaltrials.gov Identifier
NCT02580032, clinicaltrials.gov website
Duration of Study in the UK
0 years, 8 months, 15 days
Research summary
The aim of the study is to validate two measures (questionnaires) the Treatment Related Impact Measure of Childhood Growth Hormone Deficiency (TRIM-CGHD) and the Treatment Burden Measure of Childhood Growth Hormone Deficiency (TB-CGHD), which were developed to assess the degree that GHD and treatment impact patients’ daily lives and physical functioning and the treatment burden on parents/guardians to support future GHD clinical investigations.
GHD is identified as slow or flat rate of growth. Children with GHD may experience psychological and behavioural issues related to their stature. Treatment involves once daily growth hormone (GH) injections, continuing until the child reaches final height. With GH therapy, many children with GHD can reach normal height. Also, improvement in self-esteem, emotional well-being and mood of children with GHD has been shown after GH treatment.
This study intends to enroll children with GHD age 9 to less than 13 years and parents/guardians of children with GHD age 4 to less than 9 years to validate these questionnaires. For those who have been using GH therapy for at least previous 6 months, study participants will complete the questionnaire at a clinic visit and another 2 weeks later at home. For those who are newly started GH therapy, the study participants will complete the questionnaire at a clinic visit. Starting 2 weeks after the initial visit, the study participant will receive weekly 5-minute telephone interviews for up to 10 weeks. Within one week after a difference has been detected, the study participant returns to the clinic to complete a study assessment and questionnaires. All participants who newly-started GH therapy return to the clinic 12 weeks after the treatment start date to complete the study assessment and questionnaires.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
17/LO/0075
Date of REC Opinion
12 Jan 2017
REC opinion
Further Information Favourable Opinion