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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Physical 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, p
• Поведенческое Sleep 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.
• Поведенческое Weight 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.
• Другое Control: no intervention
  For 12 weeks, participants receive no program. They only fill in questionnaires through the ArtroseCoach web-app.

Первичные конечные точки

• Physical functioning [Срок оценки: From baseline until the end of the study at week 52, with assessments every 10 weeks]

Вторичные конечные точки (12)

• Numeric Pain Rating Scale [Срок оценки: From baseline until the end of the study at week 52, measured every two weeks.]
• Participation [Срок оценки: From baseline until the end of the study at week 52, measured every ten weeks.]
• Stiffness [Срок оценки: From baseline until the end of the study at week 52, measured every two weeks.]
• Self-reported active minutes [Срок оценки: From baseline until the end of the study at week 52, measured every two weeks.]
• Device measured active minutes [Срок оценки: From baseline until the end of the study at week 52, with continuous measures.]
• Fatigue [Срок оценки: From baseline until the end of the study at week 52, measured every ten weeks.]
• Job satisfaction [Срок оценки: From baseline until the end of the study at week 52, measured every ten weeks.]
• Depression and Anxiety [Срок оценки: From baseline until the end of the study at week 52, measured every ten weeks.]
• Experienced social support [Срок оценки: From baseline until the end of the study at week 52, measured every ten weeks.]
• Kinesiophobia [Срок оценки: From baseline until the end of the study at week 52, measured every ten weeks.]
• Self-efficacy [Срок оценки: From baseline until the end of the study at week 52, measured every ten weeks.]
• Insomnia severity [Срок оценки: 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.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Нидерланды · 1 центр

• UMC Utrecht — Utrecht

Публикации

• 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:e9470 PMID 42330486

Идентификаторы

NCT: NCT07423858 · NL87119.041.24 · KICH1.GZ03.21.005

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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