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.
Age ≥50 (range used in the literature covering the late-life process, including prostate issues and the perimenopause period)
Self-reported UI (at least 1 leakage/month)
Ability to read and understand the national languages
Have a mobile phone/tablet
Red-flag symptoms (e.g., bleeding)
Unstable health conditions.
Parallel
KOKU Bladder
BehavioralIn this intervention the participants will receive treatment with the KOKU app ( based digital health program with behavior change techniques to improve bladder health ) for 12 weeks. After the intervention we will collect the results with a mixed (qualitative and quantitative) approach. Qualitative information will be recorded and analysed through thematic analysis, and quantitative data will be collected with tests and questionnaires.
recommendations
BehavioralIn this intervention the participants will receive recommendations for self- managing urinary symptoms, which they must follow for 12 weeks. After the intervention we will collect the results with a mixed (qualitative and quantitative) approach. Qualitative information will be recorded and analysed through thematic analysis, and quantitative data will be collected with tests and questionnaires.
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
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
To evaluate the lower urinary tract symptoms (International Prostate Symptom Score) of community-dwelling adults aged 50 and over.
We will use different questionnaires.
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
To evaluate the satisfaction with treatment of community-dwelling adults aged 50 and over.
We will use different questionnaires.
Click on the lead sponsor to view all of their trials.
University of Vic - Central University of Catalonia
Lead sponsor
Hospital Universitari Santa Maria, Spain
Collaborator
Institut de Recerca i Innovació en Ciències de la Vida i de la Salut a la Catalunya Central (IRIS)
Collaborator
University of Manchester
Collaborator
Research Council of Lithuania
Collaborator
Lithuanian Sports University
Collaborator
Agencia Gestió Ajuts Universitaris i Recerca
Collaborator
Consorci Hospitalari de Vic (CHV)
Collaborator
