The CUSSP study
Research type
Research Study
Full title
The CloudUPDRS Smartphone Software in Parkinson’s (CUSSP) study - a pilot single-site part-blinded and cross-over randomized study comparing the validity and usability of smartphone software for home monitoring of symptoms and signs in Parkinson’s disease.
IRAS ID
204538
Contact name
Kailash Bhatia
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
MHRA Account Number, CA015327; UCL Data Protection Number, Z6364106/2016/ 04/73
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
The CloudUPDRS Smartphone Software in Parkinson’s (CUSSP) study - a pilot study investigating whether smartphone software is a valid and easy-to-use way for patients with Parkinson's Disease (PD) to monitor their symptoms at home.
Parkinson's Disease is a common neurodegenerative disorder affecting 80-127,000 people in the UK. One key issue is how to monitor their symptoms and signs, which can be very challenging, especially later in the disease where symptoms vary from hour to hour through the day. This trial evaluates a novel smartphone App (the 'CloudUPDRS' App) as potential method for assessing symptoms and signs at home. The study will recruit 60 patients with Parkinson’s disease from UCLH outpatients. After screening tests for eligibility and formal consent, patients will attend hospital for a video-taped clinical assessment of their Unified Parkinson’s Disease Rating Score (UPDRS) score OFF and ON their normal medication. The primary endpoint is the Bland-Altman Agreement between the clinical UPDRS score and the smartphone derived UPDRS score in the test group (n=30).
After this, the patients will trial 3 different methods of home diarying of their symptoms (2 methods using the software application and 1 method using an established paper-based recording) each week for 3 weeks in a pseudorandomized cross-over design. The secondary endpoint is the usability of each diary as assessed by questions presented at the end of each period of monitoring.
Each participant will be involved over 1-12 months and the trial will last 18 months in total. The study is funded by Innovate UK.
REC name
London - Queen Square Research Ethics Committee
REC reference
16/LO/0965
Date of REC Opinion
22 Jun 2016
REC opinion
Favourable Opinion