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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
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, how patient experience with respect to work alliance differs between the three care models, describe the adherence to using the app in the app-based care model and to describe what patient characteristics are associated with clinically meaningful improvements in function in daily life among patients recieving app-based care. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| App-based model of care | Experimental | 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 osteoarthritis 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. |
|
| Web-based model of care | Active Comparator | The patient will get access to information about osteoarthritis and generic osteoarthritis exercises program from a web-based 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 platform or at a physical 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. |
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| Standard care | Active Comparator | Patients who are randomized to standard care receive osteoarthritis 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient information | Other | Patient education according to national guidelines, with information about e.g. disease progression, symptoms, treatment, exercise, self-care techniques and dietary information |
| 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 |
| 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). |
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Inclusion Criteria:
The participant:
Exclusion Criteria:
Patients:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Susanne Beischer, PhD | Contact | +46 (709) 941983 | susanne.beischer@gu.se | |
| Maziar Mohaddes, Assoc Prof | Contact | +46 (730) 701147 | maziar.mohaddes_ardebili@vgregion.se |
| Name | Affiliation | Role |
|---|---|---|
| Jan Kilhamn, PhD | Research, Education, Development & Innovation, Primary Health Care, Region Västra Götaland, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University Hospital | Recruiting | Gothenburg | Västra Götaland County | Sweden |
all IPD that underlie results in a publication
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Data will become available after publication of results
Analyses and additional data are available upon request
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D015207 | Osteoarthritis, Hip |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D003219 | Confidentiality |
| D015190 | Blood Glucose Self-Monitoring |
| ID | Term |
|---|---|
| D005555 | Forensic Psychiatry |
| D011570 | Psychiatry |
| D001525 | Behavioral Sciences |
| D004191 | Behavioral Disciplines and Activities |
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| Smart phone application based exercises | Other | Individually based exercise programs individualized exercises where instructions are given through real-time video or pictures in combination with written descriptions. |
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| Web based exercises | Other | Generic osteoarthritis exercise, including about 20 different exercises, provided by real-time videos and written description |
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| Group based information | Other | Osteoarthritis 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). |
|
| Supervised rehabilitation | Other | The patient is offered to regularly exercise at the clinic, individually or in a group under supervision from a physiotherapist. |
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| Self-monitoring | Other | 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 |
|
| Motivational notifications | Behavioral | Automatic and daily reminders and / or motivational notifications |
|
| Home based rehabilitation | Other | Individualized exercises that the patient performs on their own, i.e. at home or at a gym. |
|
| 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 respondents 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 respondents 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 respondents 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 respondents 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 questionnaire 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 questionnaire 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 questionnaire 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 questionnaire 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 carbon dioxide (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 user data from app | 3 months after inclusion |
| D028701 | Patient Rights |
| D006806 | Human Rights |
| D012926 | Social Control, Formal |
| D004472 | Health Care Economics and Organizations |
| D007603 | Jurisprudence |
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D000085263 | Self-Testing |
| D012648 | Self Care |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |