Developing Data Driven Algorithms for Predicting The Right Advice at The Right Time in Patients With Hip and Knee OsteoArthritis: The e-cOAch Cross-over Study
Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study aims to learn how symptoms and daily functioning change over time in people with hip or knee osteoarthritis (OA). The goal is to use this information to build computer models that can predict these changes. In the future, these models may help give people with OA the right self-care advice at the right time through a web application called ArtroseCoach. People with OA will take part in this study for one year. Every two weeks, they will fill in online questionnaires covering various aspects of their health and daily functioning, such as pain, daily activities, and participation in life. During the year, participants will be randomly assigned to one of several self-care programs in the ArtroseCoach web app. These programs focus on physical activity, weight management, or sleep. Each program lasts 12 weeks. At four points during the year (weeks 3, 15, 27, and 39), participants will receive one of these programs or no program at all. No one will receive the same program twice. The ArtroseCoach web app provides education about OA, lifestyle advice, and tips to support behavior change. The study will help researchers understand which factors are linked to changes in pain and physical functioning over time. This knowledge will be used to improve the ArtroseCoach and other future tools that support people with OA in managing their condition on their own.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Healthy Volunteers: f
View:
• Have a hip or knee joint that, self-administered through a questionnaire, meets the National
• Institute for Health and Care Excellence clinical criteria for osteoarthritis:
⁃ Aged 45 years or over and;
⁃ Activity-related pain at the joint and;
⁃ Joint morning stiffness that lasts no longer than 30 minutes or no morning stiffness at the joint;
• History of pain at the joint for at least 3 months;
• Have access to a smartphone with internet connection and an email address;
• Able to give informed consent and willing to commit to all study evaluation and assessment procedures
• Able to read and understand texts in Dutch at B1 level.
Locations
Other Locations
Netherlands
UMC Utrecht
RECRUITING
Utrecht
Contact Information
Primary
Femke Groen, MSc
f.groen-4@umcutrecht.nl
+31652783039
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2027-02
Participants
Target number of participants: 600
Treatments
Experimental: Order of arms 1. Physical activity → Weight management → Sleep → No intervention.
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).~Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
Experimental: Order of arms 2: Physical activity → Weight management → No intervention → Sleep
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).~Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
Experimental: Order of arms 3: Physical activity → Sleep → Weight management → No intervention
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).~Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
Experimental: Order of arms 4: Physical activity → Sleep → No intervention → Weight management
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).~Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
Experimental: Order of arms 5: Physical activity → No intervention → Weight management → Sleep
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).~Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
Experimental: Order of arms 6: Physical activity → No intervention → Sleep → Weight management
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).~Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
Experimental: Order of arms 7: Weight management → Physical activity → Sleep → No intervention
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).~Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
Experimental: Order of arms 8: Weight management → Physical activity → No intervention → Sleep
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).~Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
Experimental: Order of arms 9: Weight management → Sleep → Physical activity → No intervention
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).~Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
Experimental: Order of arms 10: Weight management → Sleep → No intervention → Physical activity
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).~Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
Experimental: Order of arms 11: Weight management → No intervention → Physical activity → Sleep
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).~Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
Experimental: Order of arms 12: Weight management → No intervention → Sleep → Physical activity
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).~Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
Experimental: Order of arms 13: Sleep → Physical activity → Weight management → No intervention
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).~Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
Experimental: Order of arms 14: Sleep → Physical activity → No intervention → Weight management
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).~Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
Experimental: Order of arms 15: Sleep → Weight management → Physical activity → No intervention
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).~Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
Experimental: Order of arms 16: Sleep → Weight management → No intervention → Physical activity
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).~Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
Experimental: Order of arms 17: Sleep → No intervention → Physical activity → Weight management
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).~Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
Experimental: Order of arms 18: Sleep → No intervention → Weight management → Physical activity
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).~Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
Related Therapeutic Areas
Sponsors
Collaborators: VU University of Amsterdam, Maastricht University, University of Applied Sciences Utrecht
Leads: UMC Utrecht