Digital Patient Journey Solution for Patients Undergoing Elective Hip and Knee Arthroplasty Dueto Primary Osteoarthritis

NCT04083326 | Completed

• 1 other identifier: Icory
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Elective Hip Arthroplasty (THA); Primary Elective Total Knee Arthroplasty (TKA)

Outcome Measures

Primary Outcomes (1)

• Change in Health-related quality of life measured with EuroQol EQ-5D-5L

  EuroQol EQ-5D-5L is a 5-level 5-dimensional standardized assessment tool. The index score (range 0-1 with 1 indicating perfect health and 0 indicating death) is used in the analyses.

  Change from baseline up to 6-8 weeks after TKA or at 8-12 weeks after THA

Secondary Outcomes (12)

• Change in the Western Ontario and McMaster Osteoarthritis Index (WOMAC)

  Change from baseline up to 6-8 weeks after TKA or at 8-12 weeks after THA

• Patient experience post surgery

  At discharge (1-3 days after the surgery)

• Patient experience post intervention

  6-8 weeks after TKA or at 8-12 weeks after THA

• Application user experience

  6-8 weeks after TKA or at 8-12 weeks after THA

• Technological self-efficacy

  At baseline, and 6-8 weeks after TKA or at 8-12 weeks after THA

Other Outcomes (5)

• Presurgical outpatient visits

  From baseline until the date of the surgery. The data are collected post study from the existing medical records

• Cancellation of surgery

  From baseline until the date of the surgery. The data are collected post study from the existing medical records

• Cancellation of postoperative follow-up visit

  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

Study Arms (2)

Digital Patient Journey Solution

EXPERIMENTAL

Patients in the intervention arm are provided with a digital patient journey solution used on a mobile device. The application is intended to be used during the whole care path. The patient can familiarize him-/herself to the phases of care through visual timeline representation of the care path, get information on how to prepare for a surgery, receive reminders, fill in questionnaire forms, communicate with the care personnel via messaging functionality and video calls, and search information from frequently asked questions. The application contains information about the preparation, forms for anamnesis, anesthesia and treatment follow-up, information videos and pictures, and timely and individually-tailored reminders, e.g., on when to stop eating and drinking before the surgery. In addition, the application provides instructions on how to arrive to the treatment unit and comprehensive guidance for wound care and rehabilitation at home after the operation.

Device: Digital Patient Journey Solution

Conventional care group

NO INTERVENTION

Conventional care consists of specialist assessment in conjunction with pre-operative surgical visits and patient education. Patients in the conventional care group are provided with pre- and postoperative information face-to-face by paper-based method. Patients will be admitted and mobilised on the day of the surgery, and discharged one to three days after surgery. The follow-up visit, conducted by a physiotherapist, is conducted after 6 to 8 weeks post-discharge for patients with TKA and after 8 to 12 weeks for patients with THA.

Interventions

Digital Patient Journey Solution DEVICE

Patients in the intervention arm are provided with a digital patient journey solution used on a mobile device. The application is intended to be used during the whole care path. The patient can familiarize him-/herself to the phases of care through visual timeline representation of the care path, get information on how to prepare for a surgery, receive reminders, fill in questionnaire forms, communicate with the care personnel via messaging functionality and video calls, and search information from frequently asked questions. The application contains information about the preparation, forms for anamnesis, anesthesia and treatment follow-up, information videos and pictures, and timely and individually-tailored reminders, e.g., on when to stop eating and drinking before the surgery. In addition, the application provides instructions on how to arrive to the treatment unit and comprehensive guidance for wound care and rehabilitation at home after the operation.

Digital Patient Journey Solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VTT Technical Research Centre of Finland: lead
• University of Oulu: collaborator
• Oulu University Hospital: collaborator
• Tampere University: collaborator
• Buddy Healthcare Ltd: collaborator
• Solteq Ltd: collaborator
• Near Real Ltd: collaborator

Study Sites (1)

Oulu University Hospital

Oulu, 90220, Finland

Location

Study Officials

• Minna Pikkarainen, PhD

  University of Oulu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The group allocation is masked for the surgeon and for the outcome assessors
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 10, 2019
• Study Start: September 4, 2019
• Primary Completion: May 4, 2021
• Study Completion: June 30, 2021
• Last Updated: December 1, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)