Clinical trial NCT04083326: Digital Patient Journey Solution for Patients Undergoing Elective Hip and Knee Arthroplasty Dueto Primary Osteoarthritis
Official title: Digital Patient Journey Solution for Patients Undergoing Elective Hip and Knee Arthroplasty Due to Primary Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Elective Hip Arthroplasty (THA)
Primary Elective Total Knee Arthroplasty (TKA)
Lead sponsor: VTT Technical Research Centre of Finland
Sponsor class: OTHER
Collaborators: name: University of Oulu
name: Oulu University Hospital
name: Tampere University
name: Buddy Healthcare Ltd
name: Solteq Ltd
name: Near Real Ltd
First posted: 2019-09-10
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is an interventional study which aims at assessing the effects of a digital patient journey solution in patients undergoing elective hip and knee arthroplasty due to primary osteoarthritis.

Detailed description: Traditionally, pre- and postoperative education has been provided face-to-face by paper-based methods for patients undergoing total hip arthroplasty (THA) and total knee arthroplasty (TKA). Digital patient journey solution has potential to enhance adherence to preoperative preparation and postoperative rehabilitation, and further improve patient experience, while reducing potential adverse events.

The purpose of this study is to assess a digital patient journey solution developed for patients undergoing elective hip and knee arthroplasty. The digital solution aims to support patient's preparation to and recovery from a hip and knee arthroplasty through provision of timely information and support related to preoperative preparation and postoperative rehabilitation. The information on the application is aligned with the patient's individual needs and requirements, and contains exercises to be completed daily for the duration of the program.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Undergoing primary elective total hip or knee arthroplasty
* Diagnosis of primary osteoarthritis of hip or knee (M16.0, M16.1, M17.0, M17.1)
* Ability to speak, read and understand Finnish
* Access to a web-based device

Exclusion Criteria:

* Undergoing a total hip or knee arthroplasty revision
* A bilateral total hip or knee arthroplasty
* Total hip or knee arthroplasty following a rheumatoid arthritis
* Inability to walk with use of walking aids
* Unable to see or hear that impede the use of the digital patient journey solution

Primary outcomes:
measure: Change in Health-related quality of life measured with EuroQol EQ-5D-5L
timeFrame: Change from baseline up to 6-8 weeks after TKA or at 8-12 weeks after THA
Secondary outcomes:
measure: Change in the Western Ontario and McMaster Osteoarthritis Index (WOMAC)
timeFrame: Change from baseline up to 6-8 weeks after TKA or at 8-12 weeks after THA
measure: Patient experience post surgery
timeFrame: At discharge (1-3 days after the surgery)
measure: Patient experience post intervention
timeFrame: 6-8 weeks after TKA or at 8-12 weeks after THA
measure: Application user experience
timeFrame: 6-8 weeks after TKA or at 8-12 weeks after THA
measure: Technological self-efficacy
timeFrame: At baseline, and 6-8 weeks after TKA or at 8-12 weeks after THA
measure: Self-efficacy regarding preoperative preparation
timeFrame: At baseline
measure: Self-efficacy regarding postoperative preparation
timeFrame: At discharge (1-3 days after the surgery)
measure: Self-efficacy during postoperative rehabilitation
timeFrame: At 1, 3, and 5 weeks after THA/TKA for the intervention group only
measure: Change in Oxford Hip Score (OHS)
timeFrame: 60 days prior surgery and 120 days after the surgery
measure: Change Oxford Knee Score (OKS)
timeFrame: 60 days prior surgery and 120 days after the surgery
measure: Preoperative adherence
timeFrame: From baseline until the date of the surgery for the intervention group only
measure: Postoperative adherence
timeFrame: From discharge (1-3 days after the surgery) until 6-8 weeks after TKA or at 8-12 weeks after THA for the intervention group only
Other outcomes:
measure: Presurgical outpatient visits
timeFrame: From baseline until the date of the surgery. The data are collected post study from the existing medical records
measure: Cancellation of surgery
timeFrame: From baseline until the date of the surgery. The data are collected post study from the existing medical records
measure: Cancellation of postoperative follow-up visit
timeFrame: From the date of surgery until 6-8 weeks after TKA or at 8-12 weeks after THA. The data are collected post study from the existing medical records
measure: Hospital length of stay
timeFrame: From the date of surgery until hospital discharge (after the surgery). The data are collected post study from the existing medical records
measure: Hospital readmission
timeFrame: From discharge (1-3 days after the surgery) until 6-8 weeks after TKA or at 8-12 weeks after THA. The data are collected post study from the existing medical records
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
affiliation: University of Oulu
name: Minna Pikkarainen, PhD
role: PRINCIPAL_INVESTIGATOR
References: