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

Primary Elective Hip Arthroplasty (THA) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04083326
• Other study ID #: Icory
• Status: Completed
• Phase: N/A
• Start date: September 4, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: November 2021
• Source: VTT Technical Research Centre of Finland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: June 30, 2021
• Est. primary completion date: May 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Primary Elective Hip Arthroplasty (THA)
• Primary Elective Total Knee Arthroplasty (TKA)

Intervention

Device:
• Digital Patient Journey Solution
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.

Locations

Country	Name	City	State
Finland	Oulu University Hospital	Oulu

Sponsors (7)

Lead Sponsor	Collaborator
VTT Technical Research Centre of Finland	Buddy Healthcare Ltd, Near Real Ltd, Oulu University Hospital, Solteq Ltd, Tampere University, University of Oulu

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Presurgical outpatient visits	The number of presurgical outpatient visits	From baseline until the date of the surgery. The data are collected post study from the existing medical records
Other	Cancellation of surgery	Cancellation or postponement of surgery (yes/no)	From baseline until the date of the surgery. The data are collected post study from the existing medical records
Other	Cancellation of postoperative follow-up visit	Cancellation or postponement of the postoperative follow-up visit (yes/no)	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
Other	Hospital length of stay	Hospital length of stay after TKA or THA (days)	From the date of surgery until hospital discharge (after the surgery). The data are collected post study from the existing medical records
Other	Hospital readmission	The number and date(s) for readmission(s) to the hospital	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
Primary	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	Change in the Western Ontario and McMaster Osteoarthritis Index (WOMAC)	WOMAC is a disease-specific, self-administered health status instrument assessing pain, stiffness, and function in patients with osteoarthritis. Three subscale summary scores are used in the analysis: Pain (range:0-20), Stiffness (range: 0-8), Physical function (range 0-68) with lower scores indicating better health.	Change from baseline up to 6-8 weeks after TKA or at 8-12 weeks after THA
Secondary	Patient experience post surgery	An 18-item questionnaire developed for the purposes of this study. The questionnaire entails 17 statements answered on a Likert scale and one open question for additional feedback. The questionnaire is compiled based on the following questionnaires: 11-scale by National Institute for Health and Welfare of Finland, NORPEQ, GS-PEQ and PPE- 15	At discharge (1-3 days after the surgery)
Secondary	Patient experience post intervention	An 18-item questionnaire developed for the purposes of this study. The questionnaire entails 17 statements answered on a Likert scale and one open question for additional feedback. The questionnaire is compiled based on the following questionnaires: 11-scale by National Institute for Health and Welfare of Finland, NORPEQ, GS-PEQ and PPE- 15	6-8 weeks after TKA or at 8-12 weeks after THA
Secondary	Application user experience	A 28-item questionnaire developed for the purposes of the study. The questionnaire includes questions with regard to, e.g., perceived usefulness, ease of use, ease of taking into use, and trust. The questions are drawn from Technology Acceptance Model for Mobile Services (TAMM). The questionnaire is asked from the intervention group only.	6-8 weeks after TKA or at 8-12 weeks after THA
Secondary	Technological self-efficacy	Technological self-efficacy is measured with the Healthcare Technology Self-Efficacy (HTSE) -instrument adapted to the context of digital health services.	At baseline, and 6-8 weeks after TKA or at 8-12 weeks after THA
Secondary	Self-efficacy regarding preoperative preparation	Self-efficacy is measured using a self-reported survey item developed for the purposes of this study.	At baseline
Secondary	Self-efficacy regarding postoperative preparation	Self-efficacy is measured using a self-reported survey item developed for the purposes of this study.	At discharge (1-3 days after the surgery)
Secondary	Self-efficacy during postoperative rehabilitation	Self-efficacy during rehabilitation is measured using self-reported survey items developed for the purposes of this study.	At 1, 3, and 5 weeks after THA/TKA for the intervention group only
Secondary	Change in Oxford Hip Score (OHS)	OHS is a patient-reported outcome measure tool designed to assess disability in patients undergoing total hip replacement. The summary score (range: 12-60) is used in the analyses with higher scores indicating most difficulty. OHS is collected routinely as a part of the care path. For the study purposes these data are obtained post study from the existing medical records.	60 days prior surgery and 120 days after the surgery
Secondary	Change Oxford Knee Score (OKS)	OKS is a patient-reported outcome measure tool designed to assess disability in patients undergoing total knee replacement. The summary score (range: 12-60) is used in the analyses with higher scores indicating most difficulty. OKS is collected routinely as a part of the care path. For the study purposes, these data are obtained post study from the existing medical records.	60 days prior surgery and 120 days after the surgery
Secondary	Preoperative adherence	Percentage of completed instruction sheets (denominator is the number of all instruction sheets provided to the patient through the application)	From baseline until the date of the surgery for the intervention group only
Secondary	Postoperative adherence	The proportion of completed exercises (denominator is the number of all exercises provided to the patient through the application)	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