Actively Recruiting

Phase Not Applicable
Age: 50Years - 100Years
All Genders
NCT06583733

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

Led by University of Vic - Central University of Catalonia · Updated on 2025-03-30

120

Participants Needed

4

Research Sites

183 weeks

Total Duration

On this page

Sponsors

U

University of Vic - Central University of Catalonia

Lead Sponsor

H

Hospital Universitari Santa Maria, Spain

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 50Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 50 years or older
  • Self-reported urinary incontinence with at least one leakage per month
  • Ability to read and understand the national languages
  • Own a mobile phone or tablet
  • Provide signed informed consent
Not Eligible

You will not qualify if you...

  • Presence of red-flag symptoms such as bleeding
  • Having unstable health conditions

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Lithuanian Sports University

Kaunas, Lithuania

Actively Recruiting

2

Hospital Santa Maria

Lleida, Spain

Actively Recruiting

3

Hospital Consortium of Vic

Vic, Spain

Actively Recruiting

4

University of Manchester

Manchester, United Kingdom

Not Yet Recruiting

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Research Team

J

Javier Jerez-Roig, Professor, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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