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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04083326
Recruitment Status : Active, not recruiting
First Posted : September 10, 2019
Last Update Posted : February 10, 2020
Sponsor:
Collaborators:
University of Oulu
Oulu University Hospital
Tampere University
Buddy Healthcare Ltd
Solteq Ltd
Near Real Ltd
Information provided by (Responsible Party):
VTT Technical Research Centre of Finland

Tracking Information
First Submitted Date  ICMJE August 29, 2019
First Posted Date  ICMJE September 10, 2019
Last Update Posted Date February 10, 2020
Actual Study Start Date  ICMJE September 4, 2019
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2019)
  • 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.
  • 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
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 5, 2019)
  • 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
  • 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)
  • 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)
  • 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)
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Digital Patient Journey Solution for Patients Undergoing Elective Hip and Knee Arthroplasty Dueto Primary Osteoarthritis
Official Title  ICMJE Digital Patient Journey Solution for Patients Undergoing Elective Hip and Knee Arthroplasty Due to Primary Osteoarthritis
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description:
The group allocation is masked for the surgeon and for the outcome assessors
Primary Purpose: Supportive Care
Condition  ICMJE
  • Primary Elective Hip Arthroplasty (THA)
  • Primary Elective Total Knee Arthroplasty (TKA)
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Device: Digital Patient Journey Solution
  • No Intervention: Conventional care group
    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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 7, 2020)
69
Original Estimated Enrollment  ICMJE
 (submitted: September 5, 2019)
66
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04083326
Other Study ID Numbers  ICMJE Icory
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VTT Technical Research Centre of Finland
Study Sponsor  ICMJE VTT Technical Research Centre of Finland
Collaborators  ICMJE
  • University of Oulu
  • Oulu University Hospital
  • Tampere University
  • Buddy Healthcare Ltd
  • Solteq Ltd
  • Near Real Ltd
Investigators  ICMJE
Principal Investigator: Minna Pikkarainen, PhD University of Oulu
PRS Account VTT Technical Research Centre of Finland
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP