About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Have a hip or knee joint that, self-administered through a questionnaire, meets the National
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;
Disqualifiers
Self-reported systemic arthritis (e.g., rheumatoid arthritis, gout) avoid confounding due to overlapping symptoms;
Scheduled for lower limb joint surgery within the next year or underwent lower limb joint surgery (total hip, total knee) the last year as surgical interventions could affect outcomes and confound the assessment of treatment effects.
Trial design
Crossover
Treatments tested in this trial
Physical Activity program
BehavioralAims 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.
Sleep program
BehavioralAims 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.
Weight management program
BehavioralSupports 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.
Control: no intervention
Other interventionFor 12 weeks, participants receive no program. They only fill in questionnaires through the ArtroseCoach web-app.
Treatment groups
18
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
Physical functioning
Measured using the Hip disability and Osteoarthritis Outcome Score (HOOS) or Knee injury and Osteoarthritis Outcome Score (KOOS). HOOS includes 40 items and KOOS 42 items in five subdomains of physical functioning. Each item is rated on a 5-point Likert scale. The total scores range from 0 to 100; a higher score represents better physical functioning.
Secondary outcomes
Numeric Pain Rating Scale
Numeric Pain Rating Scale is a simple scale where participants rate their pain over the past week from 0 (no pain) to 10 (worst pain imaginable). This scale is widely used to track changes in pain intensity over time.
Participation
The Patient-Reported Outcomes Measurement Information Sys-tem Experience, Short-Form (SF) version 8a. Consists of eight items, each rated on a 5-point Likert scale. Higher scores indicate a lower ability to participate in social roles and activities.
Stiffness
Measured using the Hip disability and Osteoarthritis Outcome Score (HOOS) or Knee injury and Osteoarthritis Outcome Score (KOOS). The subscale stiffness consists of two items with a 5-point Likert scale. A higher score represents less stiffness. The HOOS and KOOS also evaluate physical functioning.
Self-reported active minutes
The Brief Physical Activity Assessment Tool (or in Dutch: Vragenlijst Fysieke Activiteit (VFA)) consists of two items regarding the frequency and duration of Physical activity. The subject can be classified as insufficiently (0-3 score) or sufficiently active (\>3 score). Insufficient refers to not meeting the World Health Organization guideline of 150 minutes of moderate-to-vigorous physical activity per week.
Sponsors and contacts
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UMC Utrecht
Lead sponsor
University of Applied Sciences Utrecht
Collaborator
Maastricht University
Collaborator
VU University of Amsterdam
Collaborator