Back to resultsDigital Patient Journey Solution for Patients Undergoing Elective Hip and Knee Arthroplasty Dueto Primary Osteoarthritis
Primary Purpose
Primary Elective Hip Arthroplasty (THA), Primary Elective Total Knee Arthroplasty (TKA)
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Digital Patient Journey Solution
Sponsored by
About this trial
This is an interventional supportive care trial for Primary Elective Hip Arthroplasty (THA)
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
Sites / Locations
- Oulu University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Digital Patient Journey Solution
Conventional care group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
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
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.
Technological self-efficacy
Technological self-efficacy is measured with the Healthcare Technology Self-Efficacy (HTSE) -instrument adapted to the context of digital health services.
Self-efficacy regarding preoperative preparation
Self-efficacy is measured using a self-reported survey item developed for the purposes of this study.
Self-efficacy regarding postoperative preparation
Self-efficacy is measured using a self-reported survey item developed for the purposes of this study.
Self-efficacy during postoperative rehabilitation
Self-efficacy during rehabilitation is measured using self-reported survey items developed for the purposes of this study.
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.
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.
Preoperative adherence
Percentage of completed instruction sheets (denominator is the number of all instruction sheets provided to the patient through the application)
Postoperative adherence
The proportion of completed exercises (denominator is the number of all exercises provided to the patient through the application)
Full Information
NCT ID
NCT04083326
First Posted
August 29, 2019
Last Updated
November 30, 2021
Sponsor
VTT Technical Research Centre of Finland
Collaborators
University of Oulu, Oulu University Hospital, Tampere University, Buddy Healthcare Ltd, Solteq Ltd, Near Real Ltd
1. Study Identification
Unique Protocol Identification Number
NCT04083326
Brief Title
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
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
September 4, 2019 (Actual)
Primary Completion Date
May 4, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VTT Technical Research Centre of Finland
Collaborators
University of Oulu, Oulu University Hospital, Tampere University, Buddy Healthcare Ltd, Solteq Ltd, Near Real Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Elective Hip Arthroplasty (THA), Primary Elective Total Knee Arthroplasty (TKA)
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
The group allocation is masked for the surgeon and for the outcome assessors
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Digital Patient Journey Solution
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional care group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Digital Patient Journey Solution
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Health-related quality of life measured with EuroQol EQ-5D-5L
Description
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.
Time Frame
Change from baseline up to 6-8 weeks after TKA or at 8-12 weeks after THA
Secondary Outcome Measure Information:
Title
Change in the Western Ontario and McMaster Osteoarthritis Index (WOMAC)
Description
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.
Time Frame
Change from baseline up to 6-8 weeks after TKA or at 8-12 weeks after THA
Title
Patient experience post surgery
Description
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
Time Frame
At discharge (1-3 days after the surgery)
Title
Patient experience post intervention
Description
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
Time Frame
6-8 weeks after TKA or at 8-12 weeks after THA
Title
Application user experience
Description
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.
Time Frame
6-8 weeks after TKA or at 8-12 weeks after THA
Title
Technological self-efficacy
Description
Technological self-efficacy is measured with the Healthcare Technology Self-Efficacy (HTSE) -instrument adapted to the context of digital health services.
Time Frame
At baseline, and 6-8 weeks after TKA or at 8-12 weeks after THA
Title
Self-efficacy regarding preoperative preparation
Description
Self-efficacy is measured using a self-reported survey item developed for the purposes of this study.
Time Frame
At baseline
Title
Self-efficacy regarding postoperative preparation
Description
Self-efficacy is measured using a self-reported survey item developed for the purposes of this study.
Time Frame
At discharge (1-3 days after the surgery)
Title
Self-efficacy during postoperative rehabilitation
Description
Self-efficacy during rehabilitation is measured using self-reported survey items developed for the purposes of this study.
Time Frame
At 1, 3, and 5 weeks after THA/TKA for the intervention group only
Title
Change in Oxford Hip Score (OHS)
Description
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.
Time Frame
60 days prior surgery and 120 days after the surgery
Title
Change Oxford Knee Score (OKS)
Description
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.
Time Frame
60 days prior surgery and 120 days after the surgery
Title
Preoperative adherence
Description
Percentage of completed instruction sheets (denominator is the number of all instruction sheets provided to the patient through the application)
Time Frame
From baseline until the date of the surgery for the intervention group only
Title
Postoperative adherence
Description
The proportion of completed exercises (denominator is the number of all exercises provided to the patient through the application)
Time Frame
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 Pre-specified Outcome Measures:
Title
Presurgical outpatient visits
Description
The number of presurgical outpatient visits
Time Frame
From baseline until the date of the surgery. The data are collected post study from the existing medical records
Title
Cancellation of surgery
Description
Cancellation or postponement of surgery (yes/no)
Time Frame
From baseline until the date of the surgery. The data are collected post study from the existing medical records
Title
Cancellation of postoperative follow-up visit
Description
Cancellation or postponement of the postoperative follow-up visit (yes/no)
Time Frame
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
Title
Hospital length of stay
Description
Hospital length of stay after TKA or THA (days)
Time Frame
From the date of surgery until hospital discharge (after the surgery). The data are collected post study from the existing medical records
Title
Hospital readmission
Description
The number and date(s) for readmission(s) to the hospital
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Minna Pikkarainen, PhD
Organizational Affiliation
University of Oulu
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oulu University Hospital
City
Oulu
ZIP/Postal Code
90220
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Digital Patient Journey Solution for Patients Undergoing Elective Hip and Knee Arthroplasty Dueto Primary Osteoarthritis
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