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RecruitingNCT07423858

Predicting The Right Advice at The Right Time in Patients With Hip and Knee OsteoArthritis: the e-cOAch Cross-over.

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
Phase
N/A
Study type
Interventional
Enrollment
600 (estimated)
Sponsor
UMC Utrecht · Academic / Other
Sex
All
Age
45 Years
Healthy volunteers
Not accepted

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.

Detailed description

Objectives of this study include the following: The primary objective is to develop and evaluate data-driven models to support personalised recommendations regarding the optimal timing of self-management strategies (physical activity promotion, sleep optimization and weight management) in individuals with hip and/or knee OA. Other objectives with data from this study: To distinguish subgroups of people with hip/knee OA based on determinants of behavior. To describe the course and predictive factors of flare-ups in patients with knee and hip osteoarthritis. To describe how people with knee and/or hip osteoarthritis score on participation, and what factors influence participation. To describe how people in the e-cOAch cross-over sleep and the association between weight, physical activity, pain and quality of sleep in people with osteoarthritis.

Conditions

Interventions

TypeNameDescription
BEHAVIORALPhysical Activity programAims to increase knowledge and levels of physical activity, and improve muscle strength through three components: 1. weekly education on movement, pain, energy management, and recommended moderate to vigorous physical activity levels; 2. a graded activity module with baseline measurement (Fitbit Inspire 3 or self-reported physical activity), goal setting, weekly increases of 10% moderate to vigorous physical activity, and reinforcement; 3. strength exercises provided via instructional videos, performed twice weekly for 20 minutes. The physical activity program is developed in line with existing osteoarthritis guidelines and builds on previous research done by our team.
BEHAVIORALSleep programAims to improve insomnia severity through three components, in line with insomnia guidelines: 1. weekly education on sleep and sleep hygiene, including recommended behaviours to promote sleep hygiene (e.g., relaxation, consistent routines, environment modification, limiting caffeine and screen time); 2. behaviour change support with goal setting, tailored feedback, and prompts to encourage healthier sleep habits. 3. mindfulness exercises such as progressive muscle relaxation and meditation.
BEHAVIORALWeight management programSupports participants in adopting a healthier diet and achieving a healthier weight if needed. Participants can monitor their weight, complete a food frequency questionnaire (FFQ) for personalized feedback, and select food components to focus on. The FFQ represents the Dutch food-based dietary guidelines. Participants receive daily tips and weekly information on healthy eating and weight loss.
OTHERControl: no interventionFor 12 weeks, participants receive no program. They only fill in questionnaires through the ArtroseCoach web-app.

Timeline

Start date
2025-09-01
Primary completion
2027-02-01
Completion
2027-02-01
First posted
2026-02-20
Last updated
2026-02-20

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT07423858. Inclusion in this directory is not an endorsement.