Osteo Arthritis Knee and Hip
Conditions
Keywords
Stepped care, Self-management, Lifestyle behaviours, Movement behaviour, Sleep behaviour, Weight management, Hip and knee osteoarthritis
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.
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.
Interventions
BEHAVIORALPhysical Activity program
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.
BEHAVIORALSleep program
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.
BEHAVIORALWeight management program
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.
For 12 weeks, participants receive no program. They only fill in questionnaires through the ArtroseCoach web-app.
Sponsors
UMC Utrecht
University of Applied Sciences Utrecht
Maastricht University
VU University of Amsterdam
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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: 1. Aged 45 years or over and; 2. Activity-related pain at the joint and; 3. Joint morning stiffness that lasts no longer than 30 minutes or no morning stiffness at the joint; 2. History of pain at the joint for at least 3 months; 3. Have access to a smartphone with internet connection and an email address; 4. Able to give informed consent and willing to commit to all study evaluation and assessment procedures 5. Able to read and understand texts in Dutch at B1 level.
Exclusion criteria
1. Self-reported systemic arthritis (e.g., rheumatoid arthritis, gout) avoid confounding due to overlapping symptoms; 2. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical functioning | From baseline until the end of the study at week 52, with assessments every 10 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Numeric Pain Rating Scale | From baseline until the end of the study at week 52, measured every two weeks. | 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 | From baseline until the end of the study at week 52, measured every ten weeks. | 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 | From baseline until the end of the study at week 52, measured every two weeks. | 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 | From baseline until the end of the study at week 52, measured every two weeks. | 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. |
| Device measured active minutes | From baseline until the end of the study at week 52, with continuous measures. | 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. |
| Fatigue | From baseline until the end of the study at week 52, measured every ten weeks. | A numeric rating scale (NRS-11). One item reports fatigue on a scale from 0 (no fatigue) to 10 (extreme fatigue). |
| Job satisfaction | From baseline until the end of the study at week 52, measured every ten weeks. | A Numeric Rating Scale (NRS-11). One item reports job satisfaction on a scale from 0 (not satisfied at all) to 10 (completely satisfied). |
| Depression and Anxiety | From baseline until the end of the study at week 52, measured every ten weeks. | 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. |
| Experienced social support | From baseline until the end of the study at week 52, measured every ten weeks. | A numeric rating scale (NRS-11). One item reports experienced social support on a scale from 0 (no support) to 10 (extensive support). |
| Kinesiophobia | From baseline until the end of the study at week 52, measured every ten weeks. | 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. |
| Self-efficacy | From baseline until the end of the study at week 52, measured every ten weeks. | 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. |
| Insomnia severity | 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. | The Insomnia Severity Index has seven items that report insomnia severity on a 5-point Likert scale. A higher score indicates more severe insomnia. |
| Pain coping | From baseline until the end of the study at week 52, measured every ten weeks. | 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. |
| Weight | 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. | Participants are weighed using their own scale. The weight is recorded in kilograms to track changes over time. |
| Physical activity readiness | From baseline until the end of the study at week 52, measured every ten weeks. | 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. |
| Sleep quality | From baseline until the end of the study at week 52, measured every ten weeks. | 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. |
| Intention | 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. | parameter to change behaviour: "To what extent do you intend to \[target behavior\]?" |
| Attitude | 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. | parameter to change behaviour: "Do you find it important to \[target behavior\]?" |
| Perceived behavioural control | 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. | parameter to change behaviour: "I am confident that if I want to, I can \[target behavior\]" |
| Engagement | From baseline until the end of the study in week 52. | 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. |
| Healthcare utilization | From baseline until the end of the study in week 52, measured every four weeks. | 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. |
Countries
Netherlands
Contacts
CONTACTFemke Groen, MSc
PRINCIPAL_INVESTIGATORMartijn F. Pisters, PhD
UMC Utrecht
Outcome results
None listed