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NCT Number: NCT05584410

Digitalization of Osteoarthritis Care

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

Recruiting

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Key information

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, Sweden

Location status: Recruiting

Location contact

Maziar Mohaddes, PhD, Dr

CONTACT

Susanne Beischer, PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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)

Exclusion criteria

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

Treatment and study plan

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

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.

Web based exercises

Other

Generic osteoarthritis exercise, including about 20 different exercises, provided by real-time videos and written description

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.

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.

Primary outcomes

  1. 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).

  2. 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).

Secondary outcomes

  1. 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

    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).

  2. 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

    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. 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

    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).

  4. 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 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).

  5. The Forgotten joint score (hip/knee) (FJS)

    Time frame: baseline

    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.

  6. The Forgotten joint score (hip/knee) (FJS)

    Time frame: 3 months after inclusion

    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.

  7. The Forgotten joint score (hip/knee) (FJS)

    Time frame: 12 months after inclusion

    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.

  8. The Forgotten joint score (hip/knee) (FJS)

    Time frame: 36 months after inclusion

    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.

  9. Swedish National Board of Health and Welfare questions about physical activity

    Time frame: baseline

    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.

  10. Swedish National Board of Health and Welfare questions about physical activity

    Time frame: 3 months after inclusion

    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.

  11. Swedish National Board of Health and Welfare questions about physical activity

    Time frame: 12 months after inclusion

    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. Swedish National Board of Health and Welfare questions about physical activity

    Time frame: 36 months after inclusion

    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.

  13. Heath-related quality of life - EuroQol (EQ5-D)

    Time frame: baseline

    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.

  14. Heath-related quality of life - EuroQol (EQ5-D)

    Time frame: 3 months after inclusion

    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.

  15. Heath-related quality of life - EuroQol (EQ5-D)

    Time frame: 12 months after inclusion

    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.

  16. Heath-related quality of life - EuroQol (EQ5-D)

    Time frame: 36 months after inclusion

    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.

  17. Medtech20

    Time frame: 3 months after inclusion

    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.

  18. Working Alliance Inventory-Short Revised

    Time frame: 3 months after inclusion

    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.

  19. Pain Self-Efficacy Scale - 2 item

    Time frame: baseline

    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.

  20. Pain Self-Efficacy Scale - 2 item

    Time frame: 3 months after inclusion

    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.

  21. Pain Self-Efficacy Scale - 2 item

    Time frame: 12 months after inclusion

    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.

  22. Pain Self-Efficacy Scale - 2 item

    Time frame: 36 months after inclusion

    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.

  23. Cost Effectiveness

    Time frame: 3 months after inclusion

    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.

  24. Cost Effectiveness

    Time frame: 12 months after inclusion

    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.

  25. Cost Effectiveness

    Time frame: 36 months after inclusion

    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.

  26. Assessment of carbon dioxide (CO2) equivalent emissions in kg - travelling

    Time frame: Baseline

    Travelling to/from health care visits based on travel data reported in a questionnaire

  27. Assessment of CO2 equivalent emissions in kg - electronical devices

    Time frame: 3 months after inclusion

    Use of electronical devices in a lifecycle perspective based on user data from app

Study contacts

Contact information is provided by the study sponsor or research team.

Maziar Mohaddes, Assoc Prof

CONTACT

[email protected]

+46 (730) 701147

Susanne Beischer, PhD

CONTACT

[email protected]

+46 (709) 941983

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Official study title

Digitalization of the Care for Patients With Hip and Knee Osteoarthritis

Important dates

Study start
2022
Primary completion
2025
Study completion
2028
First posted
Oct 18, 2022
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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