Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06583733
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-01
Brief Title:
Keep on Keep Up Bladder Health Co-creating and Testing a Self-management Technological Solution for Ageing Well
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KOKU Bladder
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 KaunasLithuanian 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 quantitativequalitative 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 eg 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 andor 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
Phase II M2-5 Consultation with 4-6 experts on Badder Health BH andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None