Smart Watch Study
Research type
Research Study
Full title
GentleCath™ Air Intermittent Catheter Smartwatch Real Life Pilot Study
IRAS ID
293506
Contact name
Julie Nicholson
Contact email
Sponsor organisation
ConvaTec Limited
Duration of Study in the UK
0 years, 6 months, 17 days
Research summary
Subjects will be asked to complete a questionnaire documenting their currently level of anxiety and the ISC-Q rating their Quality of Life at baseline
The Investigator will send the subjects an Apple™ phone and an Apple™ . The subjects will be asked to wear the watch from the moment they get up until they go to bed for the duration of the study. Each time the subject self-catheterise, the subjects’ heart rate variability will be measured via the Apple™ Watch and the information recorded in software developed for the study.
The subject will note, prior to their catheterisation whether they are going to catheterise based on (a) the clock/their routine (b) normal desire to empty (c) urgency to empty or (d) other. The software application will ask them to rate their self-reported level of anxiety prior to catheterisation the level of physical activity that they had undertaken 30 minutes prior to each catheterisation. Baseline measurements will be taken to calculate heart rate variability prior to self-catheterisation. After self-catheterisation, they will asked to rate (using VAS scale) the discomfort experienced on insertion and removal of the catheter.
For the first seven days of the study, the subjects will be asked to continue to use their own existing intermittent catheter. On day 8 of the study, subjects will switch to use the GentleCath™ Air intermittent catheter. The 7 day-period is to allow the subjects to get used to the Apple watch and the protocol. The subjects will be asked to use the GentleCath™ Air for the next twenty-eight days. At the end of the study, subjects will be asked to complete the ISC-Q to rate their Quality of Life and complete the final study evaluation visit.
REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
21/NW/0159
Date of REC Opinion
16 Jul 2021
REC opinion
Further Information Favourable Opinion