RecruitingNot ApplicableNCT06583733

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

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Sponsor

University of Vic - Central University of Catalonia

Enrollment

120 participants

Start Date

Mar 24, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 50 YearsMax Age: 100 Years

Inclusion Criteria5

  • 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
  • Sign informed consent.

Exclusion Criteria2

  • Red-flag symptoms (e.g., bleeding)
  • Unstable health conditions.

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Interventions

BEHAVIORALKOKU Bladder

In 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.

BEHAVIORALrecommendations

In 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.


Locations(4)

Lithuanian Sports University

Kaunas, Lithuania

Hospital Santa Maria

Lleida, Spain

Hospital Consortium of Vic

Vic, Spain

University of Manchester

Manchester, United Kingdom

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NCT06583733


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