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Digitalization of Osteoarthritis Care

Primary Purpose

Osteoarthritis, Knee, Osteoarthritis, Hip

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Patient information
Smartphone application based exercises
Web based exercises
Group based information
Supervised rehabilitation
Self-monitoring
Motivational notifications
Home based rehabilitation
Sponsored by
Vastra Gotaland Region
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring physiotherapy, osteoarthritis, digital care

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sahlgrenska University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

App-based model of care

Web-based model of care

Standard care

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

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).
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)
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Assessment of CO2 equivalent emissions in kg - travelling
Travelling to/from health care visits based on travel data reported in a questionnaire
Assessment of CO2 equivalent emissions in kg - electronical devices
Use of electronical devices in a lifecycle perspective based on userdata from app

Full Information

First Posted
September 19, 2022
Last Updated
December 20, 2022
Sponsor
Vastra Gotaland Region
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1. Study Identification

Unique Protocol Identification Number
NCT05584410
Brief Title
Digitalization of Osteoarthritis Care
Official Title
Digitalization of the Care for Patients With Hip and Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 5, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vastra Gotaland Region

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Osteoarthritis, Hip
Keywords
physiotherapy, osteoarthritis, digital care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
315 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
App-based model of care
Arm Type
Experimental
Arm Description
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.
Arm Title
Web-based model of care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Patient information
Intervention Description
Patient education according to national guidelines, with information about e.g. disease progression, symptoms, treatment, exercise, self-care techniques and dietary information
Intervention Type
Other
Intervention Name(s)
Smartphone application based exercises
Intervention Description
Individually based exercise programs individualized exercises where instructions are given through real-time video or pictures in combination with written descriptions.
Intervention Type
Other
Intervention Name(s)
Web based exercises
Intervention Description
Generic OA exercise, including about 20 different exercises, provided by real-time videos and written description
Intervention Type
Other
Intervention Name(s)
Group based information
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Supervised rehabilitation
Intervention Description
The patient is offered to regularly exercise at the clinic, individually or in a group under supervision from a physiotherapist.
Intervention Type
Other
Intervention Name(s)
Self-monitoring
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Motivational notifications
Intervention Description
Automatic and daily reminders and / or motivational notifications
Intervention Type
Other
Intervention Name(s)
Home based rehabilitation
Intervention Description
Individualized exercises that the patient performs on their own, i.e. at home or at a gym.
Primary Outcome Measure Information:
Title
Hip dysfunction/Knee Osteoarthritis Outcome Score (HOOS/KOOS) subscale Function in daily living (ADL)
Description
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).
Time Frame
baseline to 12 months after inclusion
Title
Hip dysfunction/Knee Osteoarthritis Outcome Score (HOOS/KOOS) subscale Function in daily living (ADL)
Description
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).
Time Frame
baseline to 36 months after inclusion
Secondary Outcome Measure Information:
Title
Hip dysfunction/Knee Osteoarthritis Outcome Score (HOOS/KOOS) subscale pain, symptoms, function in sport and recreation, and knee/hip related quality of life
Description
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).
Time Frame
baseline
Title
Hip dysfunction/Knee Osteoarthritis Outcome Score (HOOS/KOOS) subscale pain, symptoms, function in sport and recreation, and knee/hip related quality of life
Description
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)
Time Frame
3 months after inclusion
Title
Hip dysfunction/Knee Osteoarthritis Outcome Score (HOOS/KOOS) subscale pain, symptoms, function in sport and recreation, and knee/hip related quality of life
Description
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).
Time Frame
12 months after inclusion
Title
Hip dysfunction/Knee Osteoarthritis Outcome Score (HOOS/KOOS) subscale pain, symptoms, function in sport and recreation, and knee/hip related quality of life
Description
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).
Time Frame
36 months after inclusion
Title
The Forgotten joint score (hip/knee) (FJS)
Description
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.
Time Frame
baseline
Title
The Forgotten joint score (hip/knee) (FJS)
Description
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.
Time Frame
3 months after inclusion
Title
The Forgotten joint score (hip/knee) (FJS)
Description
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.
Time Frame
12 months after inclusion
Title
The Forgotten joint score (hip/knee) (FJS)
Description
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.
Time Frame
36 months after inclusion
Title
Swedish National Board of Health and Welfare questions about physical activity
Description
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.
Time Frame
baseline
Title
Swedish National Board of Health and Welfare questions about physical activity
Description
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.
Time Frame
3 months after inclusion
Title
Swedish National Board of Health and Welfare questions about physical activity
Description
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.
Time Frame
12 months after inclusion
Title
Swedish National Board of Health and Welfare questions about physical activity
Description
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.
Time Frame
36 months after inclusion
Title
Heath-related quality of life - EuroQol (EQ5-D)
Description
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.
Time Frame
baseline
Title
Heath-related quality of life - EuroQol (EQ5-D)
Description
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.
Time Frame
3 months after inclusion
Title
Heath-related quality of life - EuroQol (EQ5-D)
Description
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.
Time Frame
12 months after inclusion
Title
Heath-related quality of life - EuroQol (EQ5-D)
Description
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.
Time Frame
36 months after inclusion
Title
Medtech20
Description
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.
Time Frame
3 months after inclusion
Title
Working Alliance Inventory-Short Revised
Description
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.
Time Frame
3 months after inclusion
Title
Pain Self-Efficacy Scale - 2 item
Description
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.
Time Frame
baseline
Title
Pain Self-Efficacy Scale - 2 item
Description
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.
Time Frame
3 months after inclusion
Title
Pain Self-Efficacy Scale - 2 item
Description
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.
Time Frame
12 months after inclusion
Title
Pain Self-Efficacy Scale - 2 item
Description
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.
Time Frame
36 months after inclusion
Title
Cost Effectiveness
Description
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.
Time Frame
3 months after inclusion
Title
Cost Effectiveness
Description
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.
Time Frame
12 months after inclusion
Title
Cost Effectiveness
Description
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.
Time Frame
36 months after inclusion
Title
Assessment of CO2 equivalent emissions in kg - travelling
Description
Travelling to/from health care visits based on travel data reported in a questionnaire
Time Frame
Baseline
Title
Assessment of CO2 equivalent emissions in kg - electronical devices
Description
Use of electronical devices in a lifecycle perspective based on userdata from app
Time Frame
3 months after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susanne Beischer, PhD
Phone
+46709941983
Email
susanne.beischer@gu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Maziar Mohaddes, Assoc Prof
Phone
+46 (730) 701147
Email
maziar.mohaddes_ardebili@vgregion.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Kilhamn, PhD
Organizational Affiliation
Research, Education, Development & Innovation, Primary Health Care, Region Västra Götaland, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
State/Province
Västra Götaland
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susanne Beischer, PhD
Email
susanne.beischer@gu.se
First Name & Middle Initial & Last Name & Degree
Maziar Mohaddes, PhD, Dr

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
all IPD that underlie results in a publication
IPD Sharing Time Frame
Data will become available after publication of results
IPD Sharing Access Criteria
Analyses and additional data are available upon request

Learn more about this trial

Digitalization of Osteoarthritis Care

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