Data collection to develop data driven algorithms for predicting the right advice at the right time in patients with hip and knee osteoarthritis: a cross-over study

Guidelines recommend a stepped-care strategy in patients with OA, starting with
non-operative strategies. However, there is an underuse of these treatments. AI
algorithms have the potential to provide just-in-time guidance, emphasizing the
need for further development. Understanding data-driven factors predicting OA
complaints is essential the development of future AI models.

The primary objective of this study is to collect data to develop data-driven
models to predict changes in physical functioning over time which will be used
within the ArtroseCoach web application.

This study is a cross-over study. Participants are included for one year in
their home setting.

The app features an intuitive and user-friendly interface to ensure easy
navigation. Clear and concise instructions guide users through the input
process, making it accessible to a wide range of individuals. All content is
easy to understand at a B1 Level of Dutch. Different subgroups of patients
(people with high and low digital health literacy) and HCPs tested the 1.0
prototype to ensure that the app technically works, is easy to use and relevant
to patients with OA and HCPs. The content of the ArtroseCoach web application
is based on national and international guidelines on hip or knee OA. Existing
educational materials and questionnaires are used and rewritten in B1 level.
Patients with hip and/ or knee OA as well as B1 language experts provided
feedback on the content.
The content of the app consists of different follow-up actions with education
about the disease, lifestyle advice (e.g. exercise program, weight management
program, sleep program) and healthcare professionals.

1. Start program: Every participant starts with the start program. The topics
of the start program are information about: the disease, how pain occurs in OA,
symptoms of OA, what you can do about your symptoms yourself, the importance of
exercise and healthy lifestyle and general information about OA medication. The
content is provided through text, videos and assignments.
2. Physical activity program: This program aims to increase the knowledge and
level of physical activity (PA) and to improve muscle strength and stability of
the hip and/or knee in twelve weeks. The movement program consists of three
parts: information, a graded activity program (BGA) and strength exercises.
Firstly, the information entails the influence of movement on pain, why 150
minutes of MVPA is important, chronic pain and handling energy. This
information is provided to any participant included in the movement program.
Secondly, the BGA program incorporates a baseline test, goal setting,
time-contingent PA objectives (i.e., on fixed time points) and notifications to
promote PA. An essential feature of the BGA program is the positive
reinforcement of gradual PA, despite the presence of pain. The gradual increase
in activities changes the perception that PA is related to pain and reinforces
confidence to improve PA performance. The BGA intervention can be delivered
with or without an activity tracker. In this study, 200 participants receive an
activity tracker Fitbit Inspire) which they can connect tto the ArtroseCoach
web application. The patient starts with a seven-day baseline measurement.
After those seven days, the following data is used: number of minutes of light
physical activity (LPA) and moderate and vigorous-intensity physical activity
(MVPA). The number of minutes of LPA and MVPA per week is seen as the baseline
measurement. A personal goal is set for minutes of LPA and MVPA per week,
aiming to surpass 150 minutes of MVPA per week after 12 weeks. The program will
start at 75% of baseline measurement. Each week, the recommended amount of
minutes MVPA is increased with ((personal goal - baseline) / number of weeks).
Each day, the patient receives a positive reinforcement reminder of how far
he/she is in reaching the week goal. Each week, the patient receives tailored
feedback, based on the principles of graded activity.
Thirdly, exercises are provided through videos. The participant is encouraged
to perform strength exercises twice a week for 20 minutes.
3. Sleep program: The sleep program aims to improve subjective sleep for people
with clinical insomnia in 12 weeks. Insomnia is characterized by having trouble
falling asleep, staying asleep and waking up too early. The sleep program
consists of three parts.
Firstly, there is a weekly educational theme about sleep or sleep hygiene.
Sleep hygiene refers to a set of recommended behaviours a person can engage in
throughout the day or before bedtime to promote good sleep. This includes
abstinence from caffeine, alcohol, and nicotine late in the day, the practice
of relaxation, regular exercise, regular sleep/wake times, modifying the
environment (e.g., reducing impact of noise/light), no daytime napping, and
minimal use of light-emitting devices (e.g., smartphones)14.
Secondly, participants are provided with mindful exercises (progressive muscle
relaxation, mediation/ visualization). Mindfulness-based treatments are
efficacious at reducing symptoms of insomnia and improving sleep quality.
Thirdly, participants are encouraged to adjust sleep behaviours through setting
goals, tailored feedback and prompts.
4. Weight management program: The weight management program is designed to help
participants adopting a healthier diet and achieving a healthier weight if
needed. Based on Body Mass Index (BMI) (kg/m2), age, and ethical background it
is determined whether participants have a healthy weight, under- or overweight,
or extreme under- or overweight. For those with a healthy BMI it is mentioned
that the weight management program can be used to receive advise for a healthy
diet. Individuals who are under- or overweight are advised to work towards a
healthier weight with support of the weight management program. While
individuals who are extreme under- or overweight are recommended to seek
professional assistance, but they are still able to utilize the weight
management program.
Participants are provided with a target weight, which is set at five percent
below their current weight, because this amount can reduce disability in people
with knee osteoarthritis. They are then asked to complete the *Eetscore*, a
short food frequency questionnaire evaluating diet quality across sixteen
different food components. After completing the Eetscore, participants receive
an overview with feedback for each food component, focusing on whether they
consume an appropriate amount.
Throughout the program, six weeks are dedicated to providing tips for eating
more or less from specific food components. Every week will focus on another
food component. After participants received the feedback overview, participants
are asked to select food components for which they want to receive tips. Most
components can be addressed once, some can be addressed twice. The remaining
six weeks focus on providing tips for weight loss. The twelve weeks alternate
between focusing on food components and weight loss. Every day participants are
provided a tip to aid them in their progress.
Additionally, on a weekly basis, participants receive informative texts
covering different topics. Examples of topics include *the relation between
weight and pain from OA* and *the significance of maintaining a healthy diet*.

Please see the protocol for an extensive description of the intervention

The risks for participants are expected to be negligible, since advices follow
the current literature and guidelines and are focussed on selfmanagement and
lifestyle. The burden of the data collection is relatively high, consisting
questionnaires every two weeks during 12 months. Additionally a subset of
participants will be asked to wear a wearable on their wrist during 12 months.