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

NCT ID: NCT06583733

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-24
• Study Completion Date: 2028-10-01

Brief 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.

Detailed Description

Phase I (month-M1-3): Prepare and submit protocol to Ethics Committee, conduct an updated review of the on eHealth solutions to manage UI using BCTs (e.g. training, education) that have been designed or tested in older adults, and establish contact with the Lithuanian, Spanish and UK participating institutions. Phase1 is dedicated to the management of the project throughout its duration.

Phase II (M2-5): Consultation with 4-6 experts on Badder Health (BH) and/or behavioral interventions. Develop a first iteration of the eHealth method and module.

Conduct an initial online focus group with 10-12 co-creators of UK to explore their perceived acceptability and feasibility and preferences for the eHealth program (concept development through co-creation).

Develop a first iteration of the eHealth method and module (concept development) - by Reason Digital (tech company in Manchester)

Phase III (M6-14): Organize, conduct and analyze 5 more focus group (2 in Lithuania, 1 UK and 2 Spain) with 10-12 co-creators each (community-dwelling people aged 50+ of both genders with different physical conditions and UI, health professionals and stakeholders with different backgrounds) to explore their perceived acceptability and feasibility and preferences for the eHealth program (concept development through co-creation). Secondment in University of Manchester.

Phase IV (M14-M20): Further develop the eHealth module (concept development) - by Reason Digital (tech company in Manchester)

Phase V (M21-36): Multicenter two-armed feasibility RCT study with at least 120 participants (WP3). Participants will be randomized to a control (recommendations for self- managing urinary symptoms) or intervention (KOKU Bladder) group.

Phase VI: Early and open communication and dissemination (WP4). Analysis of results.

Conditions

Urinary Incontinence in Old Age

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

control group

The control group which will receive recommendations for self- managing urinary symptoms.

There will be at least 60 participants (men and women mixed) distributed in 3 countries. It is anticipated that the multicomponent intervention will last 12 weeks.

After the intervention we will collect the results with a mixed (qualitative and quantitative) approach.

Group Type: ACTIVE_COMPARATOR

recommendations

Intervention Type: BEHAVIORAL

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.

intervention group

The intervention group, which will receive the treatment with KOKU Bladder. There will be at least 60 participants (men and women mixed) distributed in 3 countries. It is anticipated that the multicomponent intervention will last 12 weeks.

After the intervention we will collect the results with a mixed (qualitative and quantitative) approach.

Group Type: EXPERIMENTAL

KOKU Bladder

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitari Santa Maria de Lleida (GSS)

UNKNOWN

Sponsor Role: collaborator

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

UNKNOWN

Sponsor Role: collaborator

University of Manchester

OTHER

Sponsor Role: collaborator

Research Council of Lithuania

OTHER

Sponsor Role: collaborator

Lithuanian Sports University

OTHER

Sponsor Role: collaborator

Agencia Gestió Ajuts Universitaris i Recerca

UNKNOWN

Sponsor Role: collaborator

Consorci Hospitalari de Vic (CHV)

UNKNOWN

Sponsor Role: collaborator

University of Vic - Central University of Catalonia

OTHER

Sponsor Role: lead

Responsible Party

Javier Jerez Roig

Professor, Head of research group on Methodology, Methods, Models and Outcomes of Health and Social Science (M3O)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jerez-Roig, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Vic-Central University of Catalonia; Lithuanian Sports University

Locations

Lithuanian Sports University

Kaunas, , Lithuania

Site Status: RECRUITING

Hospital Santa Maria

Lleida, , Spain

Site Status: RECRUITING

Hospital Consortium of Vic

Vic, , Spain

Site Status: RECRUITING

University of Manchester

Manchester, , United Kingdom

Site Status: NOT_YET_RECRUITING

Countries

Lithuania; Spain; United Kingdom

Central Contacts

Javier Jerez-Roig, Professor, PhD

Role: CONTACT

javier.jerez@uvic.cat

+34 93 881 60 25

Facility Contacts

Marius Brazaitis, PhD, Professor

Role: primary

marius.brazaitis@lsu.lt

8-670-59637

Oscar Águila, PhD student

Role: primary

oscarkinelleida@gmail.com

973 72 72 22

Eva Borralleras-Fumaña

Role: primary

Emma Stanmore, PhD

Role: primary

emma.stanmore@manchester.ac.uk

+44 (0) 161 306 600

References

Jerez-Roig J, Aguila-Gimeno O, Brazaitis M, Solianik R, Karkauskiene E, Jarutiene L, Fuente-Vidal A, Borralleras-Fumana E, Gasteiger N, Stanmore E. Co-creating and testing a self-management digital solution for bladder health and urinary continence among people aged 50 and over: protocol for the international KOKU Bladder project. BMJ Open. 2025 Sep 11;15(9):e100487. doi: 10.1136/bmjopen-2025-100487.

Reference Type: DERIVED

PMID: 40940057 (View on PubMed)

Other Identifiers

KOKU Bladder

Identifier Type: -

Identifier Source: org_study_id