Clinical trial NCT06583733: Keep On Keep Up Bladder Health: Co-creating and Testing a Self-management Technological Solution for Ageing Well
Official title: On Any Page, Select Quit to Stop Entering Data. Data Entered on Previous Pages Will be Retained: To Complete Data Entry Later, Open the Record From the Home Page
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urinary Incontinence in Old Age
Keywords: pelvic health
urinary incontinence
aged
eHealth
behavior change
physical activity
sedentary behavior
bladder health
technology
Lead sponsor: University of Vic - Central University of Catalonia
Sponsor class: OTHER
Collaborators: name: Hospital Universitari Santa Maria de Lleida (GSS)
name: Institut de Recerca i Innovació en Ciències de la Vida i de la Salut a la Catalunya Central (IRIS)
name: University of Manchester
name: Research Council of Lithuania
name: Lithuanian Sports University
name: Agencia Gestió Ajuts Universitaris i Recerca
name: Consorci Hospitalari de Vic (CHV)
First posted: 2024-09-04
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 120 individuals will be simple randomised to a control (recommendations for self- managing urinary symptoms) or intervention (KOKU Bladder) group. It is anticipated that the multicomponent intervention will last 12 weeks and consist of health education, pelvic floor muscle exercises and BC techniques but this may vary according to the co-creation process. Measures will be assessed at baseline and end of intervention.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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
timeFrame: 3 years
Secondary outcomes:
measure: To evaluate the life-impact related to UI (Incontinence Impact Questionnaire-7) of community-dwelling adults aged 50 and over.
timeFrame: 3 years
measure: To evaluate the lower urinary tract symptoms (International Prostate Symptom Score) of community-dwelling adults aged 50 and over.
timeFrame: 3 years
measure: 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
timeFrame: 3 years
measure: To evaluate the satisfaction with treatment of community-dwelling adults aged 50 and over.
timeFrame: 3 years
measure: To modify the severity of UI (International Consultation on Incontinence Questionnaire-UI short form) of community-dwelling adults aged 50 and over
timeFrame: 3 years
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Lithuanian Sports University
city: Lleida
country: Spain
facility: Hospital Santa Maria
city: Vic
country: Spain
facility: Hospital Consortium of Vic
city: Manchester
country: United Kingdom
facility: University of Manchester
Study officials:
affiliation: University of Vic-Central University of Catalonia; Lithuanian Sports University
name: Jerez-Roig, PhD
role: PRINCIPAL_INVESTIGATOR
References: