Clinical trial NCT05584410: Digitalization of Osteoarthritis Care
Official title: Digitalization of the Care for Patients With Hip and Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Osteoarthritis, Hip
Keywords: physiotherapy
osteoarthritis
digital care
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2022-10-18
Enrollment: 315
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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, 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.

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 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

Primary outcomes:
measure: Hip dysfunction/Knee Osteoarthritis Outcome Score (HOOS/KOOS) subscale Function in daily living (ADL)
timeFrame: baseline to 12 months after inclusion
measure: Hip dysfunction/Knee Osteoarthritis Outcome Score (HOOS/KOOS) subscale Function in daily living (ADL)
timeFrame: baseline to 36 months after inclusion
Secondary outcomes:
measure: Hip dysfunction/Knee Osteoarthritis Outcome Score (HOOS/KOOS) subscale pain, symptoms, function in sport and recreation, and knee/hip related quality of life
timeFrame: baseline
measure: Hip dysfunction/Knee Osteoarthritis Outcome Score (HOOS/KOOS) subscale pain, symptoms, function in sport and recreation, and knee/hip related quality of life
timeFrame: 3 months after inclusion
measure: Hip dysfunction/Knee Osteoarthritis Outcome Score (HOOS/KOOS) subscale pain, symptoms, function in sport and recreation, and knee/hip related quality of life
timeFrame: 12 months after inclusion
measure: Hip dysfunction/Knee Osteoarthritis Outcome Score (HOOS/KOOS) subscale pain, symptoms, function in sport and recreation, and knee/hip related quality of life
timeFrame: 36 months after inclusion
measure: The Forgotten joint score (hip/knee) (FJS)
timeFrame: baseline
measure: The Forgotten joint score (hip/knee) (FJS)
timeFrame: 3 months after inclusion
measure: The Forgotten joint score (hip/knee) (FJS)
timeFrame: 12 months after inclusion
measure: The Forgotten joint score (hip/knee) (FJS)
timeFrame: 36 months after inclusion
measure: Swedish National Board of Health and Welfare questions about physical activity
timeFrame: baseline
measure: Swedish National Board of Health and Welfare questions about physical activity
timeFrame: 3 months after inclusion
measure: Swedish National Board of Health and Welfare questions about physical activity
timeFrame: 12 months after inclusion
measure: Swedish National Board of Health and Welfare questions about physical activity
timeFrame: 36 months after inclusion
measure: Heath-related quality of life - EuroQol (EQ5-D)
timeFrame: baseline
measure: Heath-related quality of life - EuroQol (EQ5-D)
timeFrame: 3 months after inclusion
measure: Heath-related quality of life - EuroQol (EQ5-D)
timeFrame: 12 months after inclusion
measure: Heath-related quality of life - EuroQol (EQ5-D)
timeFrame: 36 months after inclusion
measure: Medtech20
timeFrame: 3 months after inclusion
measure: Working Alliance Inventory-Short Revised
timeFrame: 3 months after inclusion
measure: Pain Self-Efficacy Scale - 2 item
timeFrame: baseline
measure: Pain Self-Efficacy Scale - 2 item
timeFrame: 3 months after inclusion
measure: Pain Self-Efficacy Scale - 2 item
timeFrame: 12 months after inclusion
measure: Pain Self-Efficacy Scale - 2 item
timeFrame: 36 months after inclusion
measure: Cost Effectiveness
timeFrame: 3 months after inclusion
measure: Cost Effectiveness
timeFrame: 12 months after inclusion
measure: Cost Effectiveness
timeFrame: 36 months after inclusion
measure: Assessment of carbon dioxide (CO2) equivalent emissions in kg - travelling
timeFrame: Baseline
measure: Assessment of CO2 equivalent emissions in kg - electronical devices
timeFrame: 3 months after inclusion
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
state: Västra Götaland
Study officials:
affiliation: Research, Education, Development &amp; Innovation, Primary Health Care, Region Västra Götaland, Sweden
name: Jan Kilhamn, PhD
role: PRINCIPAL_INVESTIGATOR
References: