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Completed

NCT Number: NCT04083326

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oulu University Hospital

Oulu, 90220, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

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

    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 outcomes

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

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

    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.

  2. Patient experience post surgery

    Time frame: At discharge (1-3 days after the 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

  3. Patient experience post intervention

    Time frame: 6-8 weeks after TKA or at 8-12 weeks after THA

    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

  4. Application user experience

    Time frame: 6-8 weeks after TKA or at 8-12 weeks after THA

    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.

  5. Technological self-efficacy

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

    Technological self-efficacy is measured with the Healthcare Technology Self-Efficacy (HTSE) -instrument adapted to the context of digital health services.

  6. Self-efficacy regarding preoperative preparation

    Time frame: At baseline

    Self-efficacy is measured using a self-reported survey item developed for the purposes of this study.

  7. Self-efficacy regarding postoperative preparation

    Time frame: At discharge (1-3 days after the surgery)

    Self-efficacy is measured using a self-reported survey item developed for the purposes of this study.

  8. Self-efficacy during postoperative rehabilitation

    Time frame: At 1, 3, and 5 weeks after THA/TKA for the intervention group only

    Self-efficacy during rehabilitation is measured using self-reported survey items developed for the purposes of this study.

  9. Change in Oxford Hip Score (OHS)

    Time frame: 60 days prior surgery and 120 days after the surgery

    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.

  10. Change Oxford Knee Score (OKS)

    Time frame: 60 days prior surgery and 120 days after the surgery

    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.

  11. Preoperative adherence

    Time frame: From baseline until the date of the surgery for the intervention group only

    Percentage of completed instruction sheets (denominator is the number of all instruction sheets provided to the patient through the application)

  12. Postoperative adherence

    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

    The proportion of completed exercises (denominator is the number of all exercises provided to the patient through the application)

Other outcomes

  1. Presurgical outpatient visits

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

    The number of presurgical outpatient visits

  2. Cancellation of surgery

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

    Cancellation or postponement of surgery (yes/no)

  3. Cancellation of postoperative follow-up visit

    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

    Cancellation or postponement of the postoperative follow-up visit (yes/no)

  4. Hospital length of stay

    Time frame: From the date of surgery until hospital discharge (after the surgery). The data are collected post study from the existing medical records

    Hospital length of stay after TKA or THA (days)

  5. Hospital readmission

    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

    The number and date(s) for readmission(s) to the hospital

Sponsors and collaborators

Lead sponsor

VTT Technical Research Centre of Finland

Other

Collaborators

  • Buddy Healthcare Ltd
  • Near Real Ltd
  • Oulu University Hospital
  • Solteq Ltd
  • Tampere University
  • University of Oulu

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 10, 2019
Registry last updated
Dec 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.