Monitoring in Congenital Adrenal Hyperplasia in young people
Research type
Research Study
Full title
The clinical validity and acceptability of alternative methods of monitoring for young people with Congenital Adrenal Hyperplasia (CAH)
IRAS ID
321724
Contact name
Susie Sykes
Contact email
Sponsor organisation
London South Bank University
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
4 years, 0 months, 30 days
Research summary
Congenital adrenal hyperplasia is an inherited condition, occurring in approximately 1 in 15,000 live births, but is commonly seen in a paediatric endocrine clinic. Treatment involves once daily fludrocortisone tablets, to help with salt loss, and also hydrocortisone tablets – given throughout the day, to replace the lack of steroids. This steroid replacement is often not accurate, with patients often not adhering to treatment, resulting in long term complications due to under or over replacement.
Lack of adherence is commonly seen in young people. Monitoring currently includes regular blood tests in 4 -6 monthly clinic appointments, and an annual overnight stay in hospital for 2 hourly bloods. Signs and symptoms of over treatment may take months to detect, and often can’t be recognised through these blood tests.
One aim of the study is to explore the clinical validity of novel monitoring methods, and correlate the results to blood samples. The other aim will be to ascertain if these methods are acceptable to patients.
A mixed methods study is proposed, exploring novel techniques in monitoring, including salivary samples and samples of hair, as well as taking detailed measurements of the body. The samples will be compared to routine samples of blood taken, to confirm validity. They will be undertaken either in the clinic visit, or during the stay on the ward.
I will also interview a sample of these participants, asking their opinions on these alternate monitoring methods, and whether they think they could enhance their quality of life and overall management of their condition. Interviews will be undertaken online on the MS Teams platform.
Findings of the study will aim to show whether novel methods can be introduced as part of young people’s care, improve adherence to medical management, and reduce the need to attend regular clinic appointments.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
24/ES/0036
Date of REC Opinion
13 May 2024
REC opinion
Unfavourable Opinion