Keep On Keep Up Bladder Health: Co-creating and Testing a Self-management Technological Solution for Ageing Well
NCT Number: NCT06583733
Acronym: KOKU Bladder
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Urinary Incontinence in Old Age
Interventions: BEHAVIORAL: KOKU Bladder|BEHAVIORAL: recommendations
Sponsor: University of Vic - Central University of Catalonia
Collaborators: Hospital Universitari Santa Maria de Lleida (GSS)|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)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2028-10
Locations: Lithuanian Sports University, Kaunas, Lithuania|Hospital Santa Maria, Lleida, Spain|University of Manchester, Manchester, United Kingdom

Summary:
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.

Primary Outcome Measures: To co-create, develop and test an evidence based digital health program with behavior change techniques to decrease UI of community-dwelling adults aged 50 and over, The primary aim of KOKU Bladder is to co-create and test an eHealth program to address bladder health (specifically urinary incontinence) in community-dwelling adults aged 50 and over, 3 years
Secondary Outcome Measures: To decrease the severity of UI (International Consultation on Incontinence Questionnaire-UI short form) of community-dwelling adults aged 50 and over, We will use the International Incontinence Questionnaire-Short Form (ICIQ-SF) to assess it, 3 years|To evaluate the life-impact related to UI (Incontinence Impact Questionnaire-7) of community-dwelling adults aged 50 and over., We will use the Incontinence Impact Questionnaire-7 (IIQ-7) to assess it, 3 years|To evaluate the lower urinary tract symptoms (International Prostate Symptom Score) of community-dwelling adults aged 50 and over., We will use different questionnaires., 3 years|To evaluate the Patient Global Impression of Improvement; SB (visual analogue scale, a 7-day recall period) of community-dwelling adults aged 50 and over, We will use a visual analogue scale to assess it, 3 years|To evaluate the satisfaction with treatment of community-dwelling adults aged 50 and over., We will use different questionnaires., 3 years