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

NCT ID: NCT04083326

Last Updated: 2021-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-04

Study Completion Date

2021-06-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors
The group allocation is masked for the surgeon and for the outcome assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Digital Patient Journey Solution

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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 Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oulu

OTHER

Sponsor Role collaborator

Oulu University Hospital

OTHER

Sponsor Role collaborator

Tampere University

OTHER

Sponsor Role collaborator

Buddy Healthcare Ltd

UNKNOWN

Sponsor Role collaborator

Solteq Ltd

UNKNOWN

Sponsor Role collaborator

Near Real Ltd

UNKNOWN

Sponsor Role collaborator

VTT Technical Research Centre of Finland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Minna Pikkarainen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oulu

Locations

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Oulu University Hospital

Oulu, , Finland

Site Status

Countries

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Finland

Other Identifiers

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Icory

Identifier Type: -

Identifier Source: org_study_id