Digitalization of Osteoarthritis Care

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

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis, Knee; Osteoarthritis, Hip
• Intervention / Treatment: Other: Patient information; Other: Self-monitoring; Behavioral: Motivational notifications; Other: Home based rehabilitation; Other: Supervised rehabilitation; Other: Smart phone application based exercises; Other: Web based exercises; Other: Group based information

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.

• Study Type: Interventional
• Enrollment (Estimated): 315
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Susanne Beischer, PhD; Phone Number: +46709941983; Email: susanne.beischer@gu.se
• Study Contact Backup: Name: Maziar Mohaddes, Assoc Prof; Phone Number: +46 (730) 701147; Email: maziar.mohaddes_ardebili@vgregion.se

Study Locations

• Sweden
  • Västra Götaland
    • Gothenburg, Västra Götaland, Sweden
      • Recruiting
      • Sahlgrenska University Hospital
      • Contact: Susanne Beischer, PhD; Email: susanne.beischer@gu.se
      • Contact: Maziar Mohaddes, PhD, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: App-based model of care; 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.	Other: Patient information; Patient education according to national guidelines, with information about e.g. disease progression, symptoms, treatment, exercise, self-care techniques and dietary information; Other: Self-monitoring; 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; Behavioral: Motivational notifications; Automatic and daily reminders and / or motivational notifications; Other: Smart phone application based exercises; Individually based exercise programs individualized exercises where instructions are given through real-time video or pictures in combination with written descriptions.
Active Comparator: Web-based model of care; 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.	Other: Patient information; Patient education according to national guidelines, with information about e.g. disease progression, symptoms, treatment, exercise, self-care techniques and dietary information; Other: Home based rehabilitation; Individualized exercises that the patient performs on their own, i.e. at home or at a gym.; Other: Web based exercises; Generic osteoarthritis exercise, including about 20 different exercises, provided by real-time videos and written description
Active Comparator: Standard care; 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.	Other: Patient information; Patient education according to national guidelines, with information about e.g. disease progression, symptoms, treatment, exercise, self-care techniques and dietary information; Other: Home based rehabilitation; Individualized exercises that the patient performs on their own, i.e. at home or at a gym.; Other: Supervised rehabilitation; The patient is offered to regularly exercise at the clinic, individually or in a group under supervision from a physiotherapist.; Other: Group based information; 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).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region
• Investigators: Principal Investigator: Jan Kilhamn, PhD, Research, Education, Development & Innovation, Primary Health Care, Region Västra Götaland, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: September 19, 2022
• First Submitted That Met QC Criteria: October 14, 2022
• First Posted (Actual): October 18, 2022

Study Record Updates

• Last Update Posted (Estimated): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: osteoarthritis; physiotherapy; digital care
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip
• Other Study ID Numbers: Digitalization OA care

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No