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| ID | Type | Description | Link |
|---|---|---|---|
| KICH1.GZ03.21.005 | Other Grant/Funding Number | Dutch Research Council (NWO) |
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| Name | Class |
|---|---|
| University of Applied Sciences Utrecht | OTHER |
| Maastricht University | OTHER |
| VU University of Amsterdam | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Activity program | Behavioral | Aims to increase knowledge and levels of physical activity, and improve muscle strength through three components:
The physical activity program is developed in line with existing osteoarthritis guidelines and builds on previous research done by our team. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline until the end of the study at week 52, measured every two weeks. |
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Inclusion Criteria:
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:
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Femke Groen, MSc | Contact | +31652783039 | f.groen-4@umcutrecht.nl |
| Name | Affiliation | Role |
|---|---|---|
| Martijn F. Pisters, PhD | UMC Utrecht | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMC Utrecht | Recruiting | Utrecht | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42330486 | Derived | Groen F, de Rooij M, Kloek CJJ, Veenhof C, Klein MCA, Al-Janabi A, van Haeringen ES, Ronteltap A, Paans-Cijs B, van Dongen B, Ginsel DE, Barten DA, Hoogeboom TJ, Pisters MF. Development of Data-Driven Models for Just-in-Time Digital Self-Management Advice to Improve Physical Functioning in Hip and Knee Osteoarthritis: Protocol for the e-cOAch Cross-Over Study. JMIR Res Protoc. 2026 Jun 22;15:e94709. doi: 10.2196/94709. |
| Label | URL |
|---|---|
| Project web page | View source |
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As the data is privacy-sensitive, we publish the descriptive metadata in the data repository with a description of how a data request can be made (by sending an email to the corresponding author). All data and documents in the data package will be shared under restrictions descripted below. The data package will contain: the raw data, the study protocol describing the methods and materials, the script to process the data, the scripts leading to tables and figures in the publication, a codebook with explanations on the variable names, and a 'read_me.txt' file with an overview of files included and their content and use.
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.
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 20, 2025 |
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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.
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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.
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
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| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
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| Sleep program | Behavioral | Aims to improve insomnia severity through three components, in line with insomnia guidelines:
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| 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. |
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| Control: no intervention | Other | For 12 weeks, participants receive no program. They only fill in questionnaires through the ArtroseCoach web-app. |
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| 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. |
| From baseline until the end of the study at week 52, measured every ten weeks. |
| 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. | From baseline until the end of the study at week 52, measured every two weeks. |
| 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. | From baseline until the end of the study at week 52, measured every two weeks. |
| Device measured active minutes | In a random subset (n = 200) of the study population, physical activity will be objectively measured using an activity tracker (Fitbit Inspire 3) worn in participants' home environments for the duration of the study. Device-measured active minutes (Active zone minutes) will be used to assess if someone is meeting the World Health Organization guideline of 150 minutes of moderate-to-vigorous physical activity per week. | From baseline until the end of the study at week 52, with continuous measures. |
| Fatigue | A numeric rating scale (NRS-11). One item reports fatigue on a scale from 0 (no fatigue) to 10 (extreme fatigue). | From baseline until the end of the study at week 52, measured every ten weeks. |
| Job satisfaction | A Numeric Rating Scale (NRS-11). One item reports job satisfaction on a scale from 0 (not satisfied at all) to 10 (completely satisfied). | From baseline until the end of the study at week 52, measured every ten weeks. |
| Depression and Anxiety | The Hospital Anxiety and Depression Scale. Fourteen items report anxiety and depression symptoms over the past month on a 4-point Likert scale. A higher score indicates more severe symptoms. | From baseline until the end of the study at week 52, measured every ten weeks. |
| Experienced social support | A numeric rating scale (NRS-11). One item reports experienced social support on a scale from 0 (no support) to 10 (extensive support). | From baseline until the end of the study at week 52, measured every ten weeks. |
| Kinesiophobia | The Brief Fear Of Moving has six items that report fear on a 5-point Likert Scale from 1 (strongly disagree) to 5 (strongly agree). A higher score indicates greater fear. | From baseline until the end of the study at week 52, measured every ten weeks. |
| Self-efficacy | A shortened version of the Arthritis Self-Efficacy Scale (ASES), excluding the function subscale. Eleven items that report confidence in managing arthritis-related symptoms with a 5-point Likert scale. A higher score indicates better self-efficacy. | From baseline until the end of the study at week 52, measured every ten weeks. |
| Insomnia severity | The Insomnia Severity Index has seven items that report insomnia severity on a 5-point Likert scale. A higher score indicates more severe insomnia. | From baseline until the end of the study at week 52, measured every ten weeks. This outcome is also reported at the start and end of the Sleep program (twelve weeks), the timing of the Sleep program is randomized and can start in week 3, 15, 27, 39. |
| Pain coping | Pain coping inventory has 33 items that report 6 coping styles on a 4-point Likert scale. The highest number indicates the coping style the participant applies most. | From baseline until the end of the study at week 52, measured every ten weeks. |
| Weight | Participants are weighed using their own scale. The weight is recorded in kilograms to track changes over time. | From baseline until the end of the study at week 52, measured every ten weeks. This outcome is also reported at the start and end of the Weight program (twelve weeks), the timing of the Weight program is randomized and can start in week 3, 15, 27, 39. |
| Physical activity readiness | Physical Activity Readiness Questionnaire has seven yes or no questions about health conditions. If any yes answers are giv-en, medical clearance may be needed before starting activity programs. In this study, the question about joint pain is excluded, since all participants will answer yes. | From baseline until the end of the study at week 52, measured every ten weeks. |
| Sleep quality | is reported through the Pittsburgh Sleep Quality Index (PSQI). Nineteen items that report sleep quality over the past month on a 4-point Likert scale. A higher score indicates poorer sleep quality. | From baseline until the end of the study at week 52, measured every ten weeks. |
| Intention | parameter to change behaviour: "To what extent do you intend to [target behavior]?" | From baseline until the end of the study, measured prior to any of the programs (sleep, weight, physical activity). The timing of the programs is randomized and can start in week 3, 15, 27, 39. |
| Attitude | parameter to change behaviour: "Do you find it important to [target behavior]?" | From baseline until the end of the study, measured prior to any of the programs (sleep, weight, physical activity). The timing of the programs is randomized and can start in week 3, 15, 27, 39. |
| Perceived behavioural control | parameter to change behaviour: "I am confident that if I want to, I can [target behavior]" | From baseline until the end of the study, measured prior to any of the programs (sleep, weight, physical activity). The timing of the programs is randomized and can start in week 3, 15, 27, 39. |
| Engagement | Session start times, session duration, pages visited per session, total number of clicks, reminders that were opened, reminders that led user to start app, interaction with content items, 5-point Likert scale rating for information in the app. | From baseline until the end of the study in week 52. |
| Healthcare utilization | One yes or no question that evaluates if participants have re-ceived any care in the past month for their osteoarthritis complaints. If they answered yes, participants can choose between a list of healthcare professionals. | From baseline until the end of the study in week 52, measured every four weeks. |
| Aug 28, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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