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

Официальное название

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Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• 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 [Срок оценки: 3 years]

Вторичные конечные точки (5)

• To evaluate the life-impact related to UI (Incontinence Impact Questionnaire-7) of community-dwelling adults aged 50 and over. [Срок оценки: 3 years]
• To evaluate the lower urinary tract symptoms (International Prostate Symptom Score) of community-dwelling adults aged 50 and over. [Срок оценки: 3 years]
• 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 [Срок оценки: 3 years]
• To evaluate the satisfaction with treatment of community-dwelling adults aged 50 and over. [Срок оценки: 3 years]
• To modify the severity of UI (International Consultation on Incontinence Questionnaire-UI short form) of community-dwelling adults aged 50 and over [Срок оценки: 3 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 2 центра

• Hospital Santa Maria — Lleida
• Hospital Consortium of Vic — Vic

Литва · 1 центр

• Lithuanian Sports University — Kaunas

Великобритания · 1 центр

• University of Manchester — Manchester

Публикации

• 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-2025-1004 PMID 40940057

Идентификаторы

NCT: NCT06583733 · KOKU Bladder

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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