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

NCT07423858 | Recruiting

• 2 other identifiers: NL87119.041.24KICH1.GZ03.21.005
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteo Arthritis Knee and Hip

Keywords

Stepped care; Self-management; Lifestyle behaviours; Movement behaviour; Sleep behaviour; Weight management; Hip and knee osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline until the end of the study at week 52, with assessments every 10 weeks

Secondary Outcomes (21)

• Numeric Pain Rating Scale

  From baseline until the end of the study at week 52, measured every two weeks.

• Participation

  From baseline until the end of the study at week 52, measured every ten weeks.

• Stiffness

  From baseline until the end of the study at week 52, measured every two weeks.

• Self-reported active minutes

  From baseline until the end of the study at week 52, measured every two weeks.

• Device measured active minutes

  From baseline until the end of the study at week 52, with continuous measures.

Study Arms (18)

Order of arms 1. Physical activity → Weight management → Sleep → No intervention.

EXPERIMENTAL

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.

Behavioral: Physical Activity program; Behavioral: Sleep program; Behavioral: Weight management program; Other: Control: no intervention

Order of arms 2: Physical activity → Weight management → No intervention → Sleep

EXPERIMENTAL

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.

Behavioral: Physical Activity program; Behavioral: Sleep program; Behavioral: Weight management program; Other: Control: no intervention

Order of arms 3: Physical activity → Sleep → Weight management → No intervention

EXPERIMENTAL

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.

Behavioral: Physical Activity program; Behavioral: Sleep program; Behavioral: Weight management program; Other: Control: no intervention

Order of arms 4: Physical activity → Sleep → No intervention → Weight management

EXPERIMENTAL

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.

Behavioral: Physical Activity program; Behavioral: Sleep program; Behavioral: Weight management program; Other: Control: no intervention

Order of arms 5: Physical activity → No intervention → Weight management → Sleep

EXPERIMENTAL

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.

Behavioral: Physical Activity program; Behavioral: Sleep program; Behavioral: Weight management program; Other: Control: no intervention

Order of arms 6: Physical activity → No intervention → Sleep → Weight management

EXPERIMENTAL

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.

Behavioral: Physical Activity program; Behavioral: Sleep program; Behavioral: Weight management program; Other: Control: no intervention

Order of arms 7: Weight management → Physical activity → Sleep → No intervention

EXPERIMENTAL

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.

Behavioral: Physical Activity program; Behavioral: Sleep program; Behavioral: Weight management program; Other: Control: no intervention

Order of arms 8: Weight management → Physical activity → No intervention → Sleep

EXPERIMENTAL

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.

Behavioral: Physical Activity program; Behavioral: Sleep program; Behavioral: Weight management program; Other: Control: no intervention

Order of arms 9: Weight management → Sleep → Physical activity → No intervention

EXPERIMENTAL

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.

Behavioral: Physical Activity program; Behavioral: Sleep program; Behavioral: Weight management program; Other: Control: no intervention

Order of arms 10: Weight management → Sleep → No intervention → Physical activity

EXPERIMENTAL

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.

Behavioral: Physical Activity program; Behavioral: Sleep program; Behavioral: Weight management program; Other: Control: no intervention

Order of arms 11: Weight management → No intervention → Physical activity → Sleep

EXPERIMENTAL

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.

Behavioral: Physical Activity program; Behavioral: Sleep program; Behavioral: Weight management program; Other: Control: no intervention

Order of arms 12: Weight management → No intervention → Sleep → Physical activity

EXPERIMENTAL

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.

Behavioral: Physical Activity program; Behavioral: Sleep program; Behavioral: Weight management program; Other: Control: no intervention

Order of arms 13: Sleep → Physical activity → Weight management → No intervention

EXPERIMENTAL

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.

Behavioral: Physical Activity program; Behavioral: Sleep program; Behavioral: Weight management program; Other: Control: no intervention

Order of arms 14: Sleep → Physical activity → No intervention → Weight management

EXPERIMENTAL

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.

Behavioral: Physical Activity program; Behavioral: Sleep program; Behavioral: Weight management program; Other: Control: no intervention

Order of arms 15: Sleep → Weight management → Physical activity → No intervention

EXPERIMENTAL

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.

Behavioral: Physical Activity program; Behavioral: Sleep program; Behavioral: Weight management program; Other: Control: no intervention

Order of arms 16: Sleep → Weight management → No intervention → Physical activity

EXPERIMENTAL

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.

Behavioral: Physical Activity program; Behavioral: Sleep program; Behavioral: Weight management program; Other: Control: no intervention

Order of arms 17: Sleep → No intervention → Physical activity → Weight management

EXPERIMENTAL

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.

Behavioral: Physical Activity program; Behavioral: Sleep program; Behavioral: Weight management program; Other: Control: no intervention

Order of arms 18: Sleep → No intervention → Weight management → Physical activity

EXPERIMENTAL

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.

Behavioral: Physical Activity program; Behavioral: Sleep program; Behavioral: Weight management program; Other: Control: no intervention

Interventions

Weight management program BEHAVIORAL

Supports 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.

Order of arms 1. Physical activity → Weight management → Sleep → No intervention.; Order of arms 10: Weight management → Sleep → No intervention → Physical activity; Order of arms 11: Weight management → No intervention → Physical activity → Sleep; Order of arms 12: Weight management → No intervention → Sleep → Physical activity; Order of arms 13: Sleep → Physical activity → Weight management → No intervention; Order of arms 14: Sleep → Physical activity → No intervention → Weight management; Order of arms 15: Sleep → Weight management → Physical activity → No intervention; Order of arms 16: Sleep → Weight management → No intervention → Physical activity; Order of arms 17: Sleep → No intervention → Physical activity → Weight management; Order of arms 18: Sleep → No intervention → Weight management → Physical activity; Order of arms 2: Physical activity → Weight management → No intervention → Sleep; Order of arms 3: Physical activity → Sleep → Weight management → No intervention; Order of arms 4: Physical activity → Sleep → No intervention → Weight management; Order of arms 5: Physical activity → No intervention → Weight management → Sleep; Order of arms 6: Physical activity → No intervention → Sleep → Weight management; Order of arms 7: Weight management → Physical activity → Sleep → No intervention; Order of arms 8: Weight management → Physical activity → No intervention → Sleep; Order of arms 9: Weight management → Sleep → Physical activity → No intervention

Control: no intervention OTHER

For 12 weeks, participants receive no program. They only fill in questionnaires through the ArtroseCoach web-app.

Order of arms 1. Physical activity → Weight management → Sleep → No intervention.; Order of arms 10: Weight management → Sleep → No intervention → Physical activity; Order of arms 11: Weight management → No intervention → Physical activity → Sleep; Order of arms 12: Weight management → No intervention → Sleep → Physical activity; Order of arms 13: Sleep → Physical activity → Weight management → No intervention; Order of arms 14: Sleep → Physical activity → No intervention → Weight management; Order of arms 15: Sleep → Weight management → Physical activity → No intervention; Order of arms 16: Sleep → Weight management → No intervention → Physical activity; Order of arms 17: Sleep → No intervention → Physical activity → Weight management; Order of arms 18: Sleep → No intervention → Weight management → Physical activity; Order of arms 2: Physical activity → Weight management → No intervention → Sleep; Order of arms 3: Physical activity → Sleep → Weight management → No intervention; Order of arms 4: Physical activity → Sleep → No intervention → Weight management; Order of arms 5: Physical activity → No intervention → Weight management → Sleep; Order of arms 6: Physical activity → No intervention → Sleep → Weight management; Order of arms 7: Weight management → Physical activity → Sleep → No intervention; Order of arms 8: Weight management → Physical activity → No intervention → Sleep; Order of arms 9: Weight management → Sleep → Physical activity → No intervention

Physical Activity program BEHAVIORAL

Aims 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.

Order of arms 1. Physical activity → Weight management → Sleep → No intervention.; Order of arms 10: Weight management → Sleep → No intervention → Physical activity; Order of arms 11: Weight management → No intervention → Physical activity → Sleep; Order of arms 12: Weight management → No intervention → Sleep → Physical activity; Order of arms 13: Sleep → Physical activity → Weight management → No intervention; Order of arms 14: Sleep → Physical activity → No intervention → Weight management; Order of arms 15: Sleep → Weight management → Physical activity → No intervention; Order of arms 16: Sleep → Weight management → No intervention → Physical activity; Order of arms 17: Sleep → No intervention → Physical activity → Weight management; Order of arms 18: Sleep → No intervention → Weight management → Physical activity; Order of arms 2: Physical activity → Weight management → No intervention → Sleep; Order of arms 3: Physical activity → Sleep → Weight management → No intervention; Order of arms 4: Physical activity → Sleep → No intervention → Weight management; Order of arms 5: Physical activity → No intervention → Weight management → Sleep; Order of arms 6: Physical activity → No intervention → Sleep → Weight management; Order of arms 7: Weight management → Physical activity → Sleep → No intervention; Order of arms 8: Weight management → Physical activity → No intervention → Sleep; Order of arms 9: Weight management → Sleep → Physical activity → No intervention

Sleep program BEHAVIORAL

Aims 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.

Order of arms 1. Physical activity → Weight management → Sleep → No intervention.; Order of arms 10: Weight management → Sleep → No intervention → Physical activity; Order of arms 11: Weight management → No intervention → Physical activity → Sleep; Order of arms 12: Weight management → No intervention → Sleep → Physical activity; Order of arms 13: Sleep → Physical activity → Weight management → No intervention; Order of arms 14: Sleep → Physical activity → No intervention → Weight management; Order of arms 15: Sleep → Weight management → Physical activity → No intervention; Order of arms 16: Sleep → Weight management → No intervention → Physical activity; Order of arms 17: Sleep → No intervention → Physical activity → Weight management; Order of arms 18: Sleep → No intervention → Weight management → Physical activity; Order of arms 2: Physical activity → Weight management → No intervention → Sleep; Order of arms 3: Physical activity → Sleep → Weight management → No intervention; Order of arms 4: Physical activity → Sleep → No intervention → Weight management; Order of arms 5: Physical activity → No intervention → Weight management → Sleep; Order of arms 6: Physical activity → No intervention → Sleep → Weight management; Order of arms 7: Weight management → Physical activity → Sleep → No intervention; Order of arms 8: Weight management → Physical activity → No intervention → Sleep; Order of arms 9: Weight management → Sleep → Physical activity → No intervention

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UMC Utrecht: lead
• University of Applied Sciences Utrecht: collaborator
• Maastricht University: collaborator
• VU University of Amsterdam: collaborator

Study Sites (1)

UMC Utrecht

Utrecht, Netherlands

RECRUITING

Related Links

• Project web page

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Martijn F. Pisters, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Femke Groen, MSc

CONTACT

+31652783039; f.groen-4@umcutrecht.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding is not applicable in this study, as participants actively engage with the assigned self-care module within the ArtroseCoach web application. Both participants and researchers are aware of the assigned intervention.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Associate Professor, Principal Investigator

Model Details: Participants are randomized at baseline to one of 18 sequences, each representing a different order of the self-help programs within the ArtroseCoach web application (physical activity, weight management, or sleep) and a control period. The control condition consists of no program for 12 weeks. New programs begin at weeks 3, 15, 27, and 39, ensuring each program is delivered once per participant. Randomization uses a computer-generated allocation sequence. For safety, participants who are extremely underweight (Body Mass Index (BMI) \<17.5) do not receive the weight management program; instead, they have a 12-week no-intervention period and are advised to consult a dietician. Participants who are underweight (BMI \<18.5), extremely overweight (BMI \>30), or who may require medical clearance for the physical activity program (Physical Activity Readiness Questionnaire \>0) are advised to consult a healthcare professional but remain eligible for all sequences.

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: February 20, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: This study, under the Medical Research Involving Human Subjects Act (WMO), involves a medical device. Data and documentation needed to reproduce findings will be stored for at least 10 years. It will be available after publication of the current cross-over study.
• Access Criteria: In the event that peers like to reuse our data this can only be granted if the research question is in line with the original informed consent signed by the study participants. Every application therefore will be screened upon this requirement. If granted, a data usage agreement is signed by the receiving party.

Locations

NL (1)