Osteoarthritis, KneeNCT05584410
Digitalization of Osteoarthritis Care
A study testing Patient information, Smart phone application based exercises and Web based exercises in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Osteoarthritis, Knee, Osteoarthritis, Hip
- What is being tested?
- Patient information, Smart phone application based exercises and Web based exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 315 participants
- Where
- 1 siteSweden
- Study dates
- 5 Dec 2022to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 smart phone / tablet
- has been assessed not to be in need of hip or knee surgery trough triage based on a patient reported outcome (the Osteoarthritis Guidelines Instrument)
Who cannot join
- Patients:
- with secondary osteoarthritis (due to osteonecrosis)
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Sahlgrenska University Hospital
Gothenburg, Västra Götaland County
About this study
Official title: Digitalization of the Care for Patients With Hip and Knee Osteoarthritis
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
Read the detailed description
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.
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip
- Being tested
- Patient information, Smart phone application based exercises, Web based exercises, Group based information, Supervised rehabilitation
- Keywords
- physiotherapy, osteoarthritis, digital care
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient informationOther
Patient education according to national guidelines, with information about e.g. disease progression, symptoms, treatment, exercise, self-care techniques and dietary information
Smart phone application based exercisesOther
Individually based exercise programs individualized exercises where instructions are given through real-time video or pictures in combination with written descriptions.
Web based exercisesOther
Generic osteoarthritis exercise, including about 20 different exercises, provided by real-time videos and written description
Group based informationOther
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 rehabilitationOther
The patient is offered to regularly exercise at the clinic, individually or in a group under supervision from a physiotherapist.
Self-monitoringOther
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 notificationsBehavioural
Automatic and daily reminders and / or motivational notifications
Home based rehabilitationOther
Individualized exercises that the patient performs on their own, i.e. at home or at a gym.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Patient information; Other: Smart phone application based exercises; Other: Self-monitoring; Behavioral: 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. Receives: Other: Patient information; Other: Web based exercises; Other: Home based rehabilitation |
| 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. Receives: Other: Patient information; Other: Group based information; Other: Supervised rehabilitation; Other: Home based rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: baseline to 36 months after inclusion
Secondary outcomes (27)
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).
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline
Assessment of CO2 equivalent emissions in kg - electronical devices
Use of electronical devices in a lifecycle perspective based on user data from app
Measured: 3 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start5 Dec 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 315 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jan Kilhamn, PhD, Principal investigator, Research, Education, Development & Innovation, Primary Health Care, Region Västra Götaland, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584410
- Sponsor's protocol ID
- Digitalization OA care
- Status last verified
- Mar 2026
- First submitted
- 19 Sep 2022
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digitalization of the Care for Patients With Hip and Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05584410
- Acronym / sponsor ID
- Digitalization OA care
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip
- Keywords
- physiotherapy, osteoarthritis, digital care
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 315 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 18 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| App-based model of care | Experimental | Other: Patient information, Other: Smart phone application based exercises, Other: Self-monitoring, Behavioral: Motivational notificationsThe 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 | Other: Patient information, Other: Web based exercises, Other: Home based rehabilitationThe 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. |
| Standard care | Active comparator | Other: Patient information, Other: Group based information, Other: Supervised rehabilitation, Other: Home based rehabilitationPatients 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. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 smart phone / tablet
- has been assessed not to be in need of hip or knee surgery trough triage based on a patient reported outcome (the Osteoarthritis Guidelines Instrument)
Key exclusion criteria (5 listed)
- with secondary osteoarthritis (due to osteonecrosis)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient informationPatient education according to national guidelines, with information about e.g. disease progression, symptoms, treatment, exercise, self-care techniques and dietary information | Other | App-based model of care, Standard care, Web-based model of care |
| Smart phone application based exercisesIndividually based exercise programs individualized exercises where instructions are given through real-time video or pictures in combination with written descriptions. | Other | App-based model of care |
| Web based exercisesGeneric osteoarthritis exercise, including about 20 different exercises, provided by real-time videos and written description | Other | Web-based model of care |
| Group based informationOsteoarthritis 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). | Other | Standard care |
| Supervised rehabilitationThe patient is offered to regularly exercise at the clinic, individually or in a group under supervision from a physiotherapist. | Other | Standard care |
| Self-monitoringPatients 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 | Other | App-based model of care |
| Motivational notificationsAutomatic and daily reminders and / or motivational notifications | Behavioural | App-based model of care |
| Home based rehabilitationIndividualized exercises that the patient performs on their own, i.e. at home or at a gym. | Other | Standard care, Web-based model of care |
Primary outcome
Hip dysfunction/Knee Osteoarthritis Outcome Score (HOOS/KOOS) subscale Function in daily living (ADL)
Time frame: baseline to 12 months after inclusion
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).
Hip dysfunction/Knee Osteoarthritis Outcome Score (HOOS/KOOS) subscale Function in daily living (ADL)
Time frame: baseline to 36 months after inclusion
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).
27 secondary outcomes
Hip dysfunction/Knee Osteoarthritis Outcome Score (HOOS/KOOS) subscale pain, symptoms, function in sport and recreation, and knee/hip related quality of life
Time frame: baseline
Hip dysfunction/Knee Osteoarthritis Outcome Score (HOOS/KOOS) subscale pain, symptoms, function in sport and recreation, and knee/hip related quality of life
Time frame: 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
Time frame: 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
Time frame: 36 months after inclusion
The Forgotten joint score (hip/knee) (FJS)
Time frame: baseline
The Forgotten joint score (hip/knee) (FJS)
Time frame: 3 months after inclusion
The Forgotten joint score (hip/knee) (FJS)
Time frame: 12 months after inclusion
The Forgotten joint score (hip/knee) (FJS)
Time frame: 36 months after inclusion
Swedish National Board of Health and Welfare questions about physical activity
Time frame: baseline
Swedish National Board of Health and Welfare questions about physical activity
Time frame: 3 months after inclusion
Swedish National Board of Health and Welfare questions about physical activity
Time frame: 12 months after inclusion
Swedish National Board of Health and Welfare questions about physical activity
Time frame: 36 months after inclusion
Heath-related quality of life - EuroQol (EQ5-D)
Time frame: baseline
Heath-related quality of life - EuroQol (EQ5-D)
Time frame: 3 months after inclusion
Heath-related quality of life - EuroQol (EQ5-D)
Time frame: 12 months after inclusion
Heath-related quality of life - EuroQol (EQ5-D)
Time frame: 36 months after inclusion
Medtech20
Time frame: 3 months after inclusion
Working Alliance Inventory-Short Revised
Time frame: 3 months after inclusion
Pain Self-Efficacy Scale - 2 item
Time frame: baseline
Pain Self-Efficacy Scale - 2 item
Time frame: 3 months after inclusion
Pain Self-Efficacy Scale - 2 item
Time frame: 12 months after inclusion
Pain Self-Efficacy Scale - 2 item
Time frame: 36 months after inclusion
Cost Effectiveness
Time frame: 3 months after inclusion
Cost Effectiveness
Time frame: 12 months after inclusion
Cost Effectiveness
Time frame: 36 months after inclusion
Assessment of carbon dioxide (CO2) equivalent emissions in kg - travelling
Time frame: Baseline
Assessment of CO2 equivalent emissions in kg - electronical devices
Time frame: 3 months after inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Kilhamn, PhD principal investigator
Research, Education, Development & Innovation, Primary Health Care, Region Västra Götaland, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient information, Smart phone application based exercises and Web based exercises in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hip dysfunction/Knee Osteoarthritis Outcome Score (HOOS/KOOS) subscale Function in daily living (ADL) (time frame: baseline to 12 months after inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.