Keep On Keep Up Bladder Health: Co-creating and Testing a Self-management Technological Solution for Ageing Well

KOKU Bladder aims to develop and test an evidence based digital health program with behavior change techniques to improve bladder health of adults aged 50 and over. A novel module embedded in the approved app "Keep-on-Keep-up" (KOKU) will be co-created with end-users, researchers, health professionals, and stakeholders through a participatory and appreciative action and reflection methodology. After a comprehensive literature review and consultation with 4-6 experts, 6 focus groups will be undertaken in Kaunas(Lithuanian), Catalonia (Spain) and Manchester (UK) to co-create the contents of the module. Data will be analyzed using thematic analysis. Gamification and the Honeycomb model for user experience will be followed to achieve an appropriate technological solution that will be tested through a randomized controlled trial with at least 120 individuals. A mixed methods approach (quantitative/qualitative analysis) will be used to assess the feasibility and acceptability of the program. Open data and science, gender and ethical aspects, as well as a risk management plan are considered. A plan for communication, dissemination, exploitation of results will be considered. KOKU Bladder will be highly scalable and will have wide reach and impact. This proposal is in line with EU policy initiatives on Active and Healthy Ageing (bladder health and continence will be promoted), targeting aspects such as eHealth, Innovation and Digital Care Transformation, by supporting users to demand more responsive and integrated care programs for chronic conditions and enhancing self-management strategies, independence and health intelligence.

NCT Number	NCT06583733
Lead Sponsor	University of Vic - Central University of Catalonia Collaborators: Hospital Universitari Santa Maria, Spain, Institut de Recerca i Innovació en Ciències de la Vida i de la Salut a la Catalunya Central (IRIS), University of Manchester, Research Council of Lithuania, Lithuanian Sports University, Agencia Gestió Ajuts Universitaris i Recerca, Consorci Hospitalari de Vic (CHV)
Conditions	Urinary Incontinence in Old Age
Enrollment	120 participants
Start Date	2025-03-24
Primary Completion	2027-08-31 (estimated)
Study Completion	2028-10-01 (estimated)
Updated on ClinicalTrials.gov	2025-03-30