The DialogueStudy is a global clinical study designed to document the real life experience of Coloplast’s SenSura ostomy appliance, focusing specifically on skin condition and quality of life. The study will run from January 2008 to March 2010 covering countries in most regions of the world.
Real life studies are designed to detect long-term effects in a much larger patient population and over a longer period of time than is typically possible during the clinical trial conducted in a product’s development phase.
Involving 5,000 people with a stoma worldwide, the DialogueStudy will be the largest clinical study ever undertaken within ostomy care.
Our earlier study – the OstomySkinStudy – revealed a high frequency of peristomal skin disorders, but did not investigate the influence of skin condition on the quality of life of people with a stoma.
Involving people who suffer from skin problems and those who don’t, the DialogueStudy aims to investigate the relationship between skin condition and quality of life. Hopefully, this will provide valuable data on the kind of preventive measures and product improvements that are needed.
The DialogueStudy uses three of our new clinical tools and modes of assessments: - the validated Stoma-QoL designed specifically for people with an ostomy
- the Ostomy Skin Tool which will be validated as part of the DialogueStudy
- the Ostomy Appliance Questionnaire
If you’d like to know more about the DialogueStudy, please contact your local Coloplast office
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