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

NCT06583733 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-03-30

No results posted yet for this study

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.

Conditions

  • Urinary Incontinence in Old Age

Interventions

BEHAVIORAL

KOKU 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.

BEHAVIORAL

recommendations

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.

Sponsors & Collaborators

  • Hospital Universitari Santa Maria de Lleida (GSS)

    collaborator UNKNOWN
  • Institut de Recerca i Innovació en Ciències de la Vida i de la Salut a la Catalunya Central (IRIS)

    collaborator UNKNOWN
  • University of Manchester

    collaborator OTHER
  • Research Council of Lithuania

    collaborator OTHER
  • Lithuanian Sports University

    collaborator OTHER
  • Agencia Gestió Ajuts Universitaris i Recerca

    collaborator UNKNOWN
  • Consorci Hospitalari de Vic (CHV)

    collaborator UNKNOWN
  • University of Vic - Central University of Catalonia

    lead OTHER

Principal Investigators

  • Jerez-Roig, PhD · University of Vic-Central University of Catalonia; Lithuanian Sports University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-24
Primary Completion
2027-08-31
Completion
2028-10-01

Countries

  • Lithuania
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06583733 on ClinicalTrials.gov