Digitalization of Osteoarthritis Care

Study Overview
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Brief Summary
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The overall aim of this study is to compare three different care models for patients with hip- and knee osteoarthritis. The primary aim is to evaluate whether an app-based care model is more beneficial for improving function in daily life than a web-based care model and standard care for patients with hip and / or knee osteoarthritis

Detailed Description
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The primary aim of this study is to evaluate whether an app-based care model is more beneficial for improving function in daily life than a web-based care model and standard care for patients with hip and / or knee osteoarthritis. The secondary aims are to evaluate how 1) patient-related outcome measures regarding the ability of the patient to forget about their problematic joint after treatment, quality of life, pain-related self-efficacy, and level of physical activity and 2) care consumption, cost-effectiveness, and carbon footprint differ between the three care models in a short-term (three months) and long-term perspective (one and three years respectively). Further aims are to evaluate how patient experience of the benefits provided by the two digital care models differs and how patient experience with respect to work alliance differs between the three care models. The primary hypothesis is that patients who are randomized to an app-based care model will improve significantly more in terms of function in daily life from baseline to one year compared with patients who are randomized to a web-based model and usual care. The secondary hypothesis is that patients randomized to the app-based care model change equivalently from baseline to one year in terms of patient-reported measures, but that the app-based care model is more cost-effective compared with the other two care models at one and three years, respectively.

Official Title
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Digitalization of the Care for Patients With Hip and Knee Osteoarthritis

Conditions
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Osteoarthritis, Knee, Osteoarthritis, Hip

Intervention / Treatment
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* Other: Patient information
* Other: Smartphone application based exercises
* Other: Web based exercises
* Other: Group based information
* Other: Supervised rehabilitation
* Other: Self-monitoring
* Behavioral: Motivational notifications
* Other: Home based rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The participant: has given their written consent to participate in the study has been referred to the orthopaedic clinic at Sahlgrenska University Hospital /Mölndal for primary hip- and or knee osteoarthritis has a positive attitude in using digital tools has access to a smartphone / tablet has been assessed not to be in need of hip or knee surgery Exclusion Criteria: Patients: with secondary osteoarthritis (due to previous injury or necrosis) referred to a specific orthopaedic surgeon with impaired mental ability, reluctance or language difficulties that make it difficult to understand the meaning of participating in the study who undergo treatment, have disability or illness that according to the research group can affect the treatment or the study result

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: App-based model of care<br>The app-based model of care includes at least one physical visit at the clinic. The majority of the treatment is provided by the app, containing five different sections: 1) My information: specific information regarding OA and generic lifestyle advice. 2 & 3) My exercise & My plan: individualized exercises where instructions are given through real-time video or pictures and written descriptions. The patient has access to a calendar and an overview of scheduled rehabilitation/exercises and care meetings. 4) My progress: weekly assessment of pain + every six-month with valid patient reported outcome measures and test of function. 5) My messages (asynchronous chat with the responsible physiotherapist). The app sends automatic and daily reminders and / or motivational notifications. | Other: Patient information<br>* Patient education according to national guidelines, with information about e.g. disease progression, symptoms, treatment, exercise, self-care techniques and dietary information<br>Other: Smartphone application based exercises<br>* Individually based exercise programs individualized exercises where instructions are given through real-time video or pictures in combination with written descriptions.<br>Other: Self-monitoring<br>* Patients will be followed by validated questionnaires and function tests (30 sec Chair-to-stand test) every six months until three years after the start of treatment. The patients will get a report of the results and a research coordinator will contact the patients if their symptoms/function has worsen and discuss further treatment<br>Behavioral: Motivational notifications<br>* Automatic and daily reminders and / or motivational notifications<br>|
| Active Comparator: Web-based model of care<br>The patient will get access to information about OA and generic OA exercises program from a webbased platform Individualization of the training can be done by the responsible physiotherapist informing about changes in the training via the message function and / or during physical follow-up visits. An individualized rehabilitation program can be given to the patient, via the plattform or at a physcal visit at the clinic, in form of a document with pictures and descriptive information. As long as the patient is under treatment (approximately three months), he/she can contact their responsible physiotherapist by sending a message from the platform. | Other: Patient information<br>* Patient education according to national guidelines, with information about e.g. disease progression, symptoms, treatment, exercise, self-care techniques and dietary information<br>Other: Web based exercises<br>* Generic OA exercise, including about 20 different exercises, provided by real-time videos and written description<br>Other: Home based rehabilitation<br>* Individualized exercises that the patient performs on their own, i.e. at home or at a gym.<br>|
| Active Comparator: Standard care<br>Patients who are randomized to standard care receive OA specific information at three different group meetings (physical or digital) led by a physiotherapist, an occupational therapist and / or dietitian (each rehab clinic makes its own arrangement). After the theory sessions, the patient is booked for another physical visit to the responsible physiotherapist where an individual training program is tested. The patient is then offered to regularly exercise at the clinic, individually or in a group under supervision from a physiotherapist. | Other: Patient information<br>* Patient education according to national guidelines, with information about e.g. disease progression, symptoms, treatment, exercise, self-care techniques and dietary information<br>Other: Group based information<br>* OA specific information at three different group meeting (physical or digital) led by a physiotherapist, an occupational therapist and / or dietitian (each rehab clinic makes its own arrangement).<br>Other: Supervised rehabilitation<br>* The patient is offered to regularly exercise at the clinic, individually or in a group under supervision from a physiotherapist.<br>Other: Home based rehabilitation<br>* Individualized exercises that the patient performs on their own, i.e. at home or at a gym.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hip dysfunction/Knee Osteoarthritis Outcome Score (HOOS/KOOS) subscale Function in daily living (ADL) | The KOOS/HOOS questionnaires were developed as instruments to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales: Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale (scoring instructions are available in a separate document). | baseline to 12 months after inclusion | 
| Hip dysfunction/Knee Osteoarthritis Outcome Score (HOOS/KOOS) subscale Function in daily living (ADL) | The KOOS/HOOS questionnaires were developed as instruments to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales: Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale (scoring instructions are available in a separate document). | baseline to 36 months after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hip dysfunction/Knee Osteoarthritis Outcome Score (HOOS/KOOS) subscale pain, symptoms, function in sport and recreation, and knee/hip related quality of life | The KOOS/HOOS questionnaires were developed as instruments to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales: Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale (scoring instructions are available in a separate document). | baseline | 
| Hip dysfunction/Knee Osteoarthritis Outcome Score (HOOS/KOOS) subscale pain, symptoms, function in sport and recreation, and knee/hip related quality of life | The KOOS/HOOS questionnaires were developed as instruments to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales: Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale (scoring instructions are available in a separate document) | 3 months after inclusion | 
| Hip dysfunction/Knee Osteoarthritis Outcome Score (HOOS/KOOS) subscale pain, symptoms, function in sport and recreation, and knee/hip related quality of life | The KOOS/HOOS questionnaires were developed as instruments to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales: Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale (scoring instructions are available in a separate document). | 12 months after inclusion | 
| Hip dysfunction/Knee Osteoarthritis Outcome Score (HOOS/KOOS) subscale pain, symptoms, function in sport and recreation, and knee/hip related quality of life | The KOOS/HOOS questionnaires were developed as instruments to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales: Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale (scoring instructions are available in a separate document). | 36 months after inclusion | 
| The Forgotten joint score (hip/knee) (FJS) | A questionnaire that was developed to find subtle differences between patients who grade their hip / knee as very good and excellent. The score is graded from 0 to 100, where a higher score is better. | baseline | 
| The Forgotten joint score (hip/knee) (FJS) | A questionnaire that was developed to find subtle differences between patients who grade their hip / knee as very good and excellent. The score is graded from 0 to 100, where a higher score is better. | 3 months after inclusion | 
| The Forgotten joint score (hip/knee) (FJS) | A questionnaire that was developed to find subtle differences between patients who grade their hip / knee as very good and excellent. The score is graded from 0 to 100, where a higher score is better. | 12 months after inclusion | 
| The Forgotten joint score (hip/knee) (FJS) | A questionnaire that was developed to find subtle differences between patients who grade their hip / knee as very good and excellent. The score is graded from 0 to 100, where a higher score is better. | 36 months after inclusion | 
| Swedish National Board of Health and Welfare questions about physical activity | Questions intended for use in clinical health care to identify people that are insufficiently physically active. The respodents report their total time, in minutes, of moderate and vigorous physical activity, respectively, during a normal week on a categorical scale from a) 0-30 minutes, up to g) >300 minutes. | baseline | 
| Swedish National Board of Health and Welfare questions about physical activity | Questions intended for use in clinical health care to identify people that are insufficiently physically active. The respodents report their total time, in minutes, of moderate and vigorous physical activity, respectively, during a normal week on a categorical scale from a) 0-30 minutes, up to g) >300 minutes. | 3 months after inclusion | 
| Swedish National Board of Health and Welfare questions about physical activity | Questions intended for use in clinical health care to identify people that are insufficiently physically active. The respodents report their total time, in minutes, of moderate and vigorous physical activity, respectively, during a normal week on a categorical scale from a) 0-30 minutes, up to g) >300 minutes. | 12 months after inclusion | 
| Swedish National Board of Health and Welfare questions about physical activity | Questions intended for use in clinical health care to identify people that are insufficiently physically active. The respodents report their total time, in minutes, of moderate and vigorous physical activity, respectively, during a normal week on a categorical scale from a) 0-30 minutes, up to g) >300 minutes. | 36 months after inclusion | 
| Heath-related quality of life - EuroQol (EQ5-D) | Measure of health-related quality of life and consists of 5 items. General health is measured using a visual analog scale (0 to 100) with 100 being the best possible health state. | baseline | 
| Heath-related quality of life - EuroQol (EQ5-D) | Measure of health-related quality of life and consists of 5 items. General health is measured using a visual analog scale (0 to 100) with 100 being the best possible health state. | 3 months after inclusion | 
| Heath-related quality of life - EuroQol (EQ5-D) | Measure of health-related quality of life and consists of 5 items. General health is measured using a visual analog scale (0 to 100) with 100 being the best possible health state. | 12 months after inclusion | 
| Heath-related quality of life - EuroQol (EQ5-D) | Measure of health-related quality of life and consists of 5 items. General health is measured using a visual analog scale (0 to 100) with 100 being the best possible health state. | 36 months after inclusion | 
| Medtech20 | A standardized tool measuring how medical devices affect people's sense of security, integrity, social participation and convenience. Each item is rated on a seven graded Likert-scale from, 0 = disagree to 6 = completely agree. Each item also has a Not applicable response option. A higher score indicates a better effect of the medical device. | 3 months after inclusion | 
| Working Alliance Inventory-Short Revised | A recently refined measure of the therapeutic alliance that assesses three key aspects of the therapeutic alliance: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond. The questionnaire is validated, has acceptable reliability and includes 12 items. The patient rates each item on a seven graded Likert-scale from 1 = not at all to 7 = completely. A higher score indicates a better therapeutic alliance. | 3 months after inclusion | 
| Pain Self-Efficacy Scale - 2 item | The Pain Self-Efficacy Questionnaire (PSEQ) is an established 10-item measure of pain self-efficacy that is widely used in clinical and research settings. In the present study a short form of the original qustionnaire will be used. The two items are graded from 0 = not at all certain to 6 = very certain. | baseline | 
| Pain Self-Efficacy Scale - 2 item | The Pain Self-Efficacy Questionnaire (PSEQ) is an established 10-item measure of pain self-efficacy that is widely used in clinical and research settings. In the present study a short form of the original qustionnaire will be used. The two items are graded from 0 = not at all certain to 6 = very certain. | 3 months after inclusion | 
| Pain Self-Efficacy Scale - 2 item | The Pain Self-Efficacy Questionnaire (PSEQ) is an established 10-item measure of pain self-efficacy that is widely used in clinical and research settings. In the present study a short form of the original qustionnaire will be used. The two items are graded from 0 = not at all certain to 6 = very certain. | 12 months after inclusion | 
| Pain Self-Efficacy Scale - 2 item | The Pain Self-Efficacy Questionnaire (PSEQ) is an established 10-item measure of pain self-efficacy that is widely used in clinical and research settings. In the present study a short form of the original qustionnaire will be used. The two items are graded from 0 = not at all certain to 6 = very certain. | 36 months after inclusion | 
| Cost Effectiveness | Indirect and direct health care costs. Total costs, costs per patient and per visit. Loss of income will be reported as number of days of abscence due to illness. | 3 months after inclusion | 
| Cost Effectiveness | Indirect and direct health care costs. Total costs, costs per patient and per visit. Loss of income will be reported as number of days of abscence due to illness. | 12 months after inclusion | 
| Cost Effectiveness | Indirect and direct health care costs. Total costs, costs per patient and per visit. Loss of income will be reported as number of days of abscence due to illness. | 36 months after inclusion | 
| Assessment of CO2 equivalent emissions in kg - travelling | Travelling to/from health care visits based on travel data reported in a questionnaire | Baseline | 
| Assessment of CO2 equivalent emissions in kg - electronical devices | Use of electronical devices in a lifecycle perspective based on userdata from app | 3 months after inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physiotherapy, osteoarthritis, digital care