An Evaluation of the Solaticare System of Hygienic Care
Research type
Research Study
Full title
An Evaluation of the Solaticare System of Hygienic Care, and its acceptability into the UK Health Economy.
IRAS ID
193292
Contact name
Prableen Sethi Kohli
Contact email
Sponsor organisation
Novamed (Europe) limited
Duration of Study in the UK
0 years, 3 months, 15 days
Research summary
Clinical research for evaluation of the Solaticare System - To assess the system’s acceptability to users and carers. To ensure that this system works appropriately in real life settings
Solaticare is a combined toilet and bidet system for use in bed. It has been designed for the benefit of both users and carers, to enable urination and defecation without bedpan or continence pads. It promotes dignity by allowing the user an independent solution to their need to eliminate. Participants will be continent adults, who are bed-bound with limited mobility and have functional issues accessing the toileting facilities independently. Solaticare is a novel approach to a longstanding issue, it was felt that it could benefit from a methodical approach to evaluation of both its benefits and acceptability to the UK population. In cultures where washing with water is norm, the concept has been quickly accepted.
Both versions of the Solaticare System will be tested by a total of 10 users, i.e. 5 to test he mattress system, and 5 for the profiling bed system within the Health Services. Potential participants will be screed for suitability initially by their own direct healthcare provider and then be confirmed by Novamed – Clinical Advisor, as well as giving informed consent. The research duration is planned to be a maximum 28 days.
Product will be evaluated based on the feedback provided by both participants and their carers/nurses. Questionnaires will be completed weekly by participants not taking them more than 15 – 20 minutes. One questionnaire will be completed on weekly basis by the carers/nurse not taking more than 15 minutes and one questionnaire daily by the carer/nurse not taking more than 5 minutes. Many of the comments from the users will be quite subjective, as will some of those from carers. These questionnaires will inform evaluation of both product design and acceptability within the UK. Recording user gender will allow evaluation of any gender bias in design, and thus inform future development.
Success will be assessed by numerical values being given to answers, and will include the subjective evaluation.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
16/SC/0333
Date of REC Opinion
29 Jul 2016
REC opinion
Further Information Favourable Opinion