Primary Elective Hip Arthroplasty (THA)NCT04083326
Digital Patient Journey Solution for Patients Undergoing Elective Hip and Knee Arthroplasty Dueto Primary Osteoarthritis
A study testing Digital Patient Journey Solution in people with Primary Elective Hip Arthroplasty (THA) and Primary Elective Total Knee Arthroplasty (TKA), run by VTT Technical Research Centre of Finland at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Elective Hip Arthroplasty (THA), Primary Elective Total Knee Arthroplasty (TKA)
- What is being tested?
- Digital Patient Journey Solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteFinland
- Study dates
- 4 Sep 2019to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Digital Patient Journey Solution for Patients Undergoing Elective Hip and Knee Arthroplasty Due to 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.
Read the 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.
- Being tested
- Digital Patient Journey Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Patient Journey SolutionDevice
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 group | Role | What they receive |
|---|---|---|
| Digital Patient Journey Solution | Experimental | 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. Receives: Device: Digital Patient Journey Solution |
| Conventional care group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline up to 6-8 weeks after TKA or at 8-12 weeks after THA
Secondary outcomes (12)
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.
Measured: Change from baseline up to 6-8 weeks after TKA or at 8-12 weeks after THA
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
Measured: At discharge (1-3 days after the surgery)
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
Measured: 6-8 weeks after TKA or at 8-12 weeks after THA
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.
Measured: 6-8 weeks after TKA or at 8-12 weeks after THA
Technological self-efficacy
Technological self-efficacy is measured with the Healthcare Technology Self-Efficacy (HTSE) -instrument adapted to the context of digital health services.
Measured: At baseline, and 6-8 weeks after TKA or at 8-12 weeks after THA
Self-efficacy regarding preoperative preparation
Self-efficacy is measured using a self-reported survey item developed for the purposes of this study.
Measured: At baseline
Self-efficacy regarding postoperative preparation
Self-efficacy is measured using a self-reported survey item developed for the purposes of this study.
Measured: At discharge (1-3 days after the surgery)
Self-efficacy during postoperative rehabilitation
Self-efficacy during rehabilitation is measured using self-reported survey items developed for the purposes of this study.
Measured: At 1, 3, and 5 weeks after THA/TKA for the intervention group only
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.
Measured: 60 days prior surgery and 120 days after the surgery
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.
Measured: 60 days prior surgery and 120 days after the surgery
Preoperative adherence
Percentage of completed instruction sheets (denominator is the number of all instruction sheets provided to the patient through the application)
Measured: From baseline until the date of the surgery for the intervention group only
Postoperative adherence
The proportion of completed exercises (denominator is the number of all exercises provided to the patient through the application)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start4 Sep 2019
- Primary completion4 May 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Elective Hip Arthroplasty (THA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- VTT Technical Research Centre of Finland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oulu, Oulu University Hospital, Tampere University, Buddy Healthcare Ltd, Solteq Ltd, Near Real Ltd
- Responsible party
- Sponsor
- Investigators
- Minna Pikkarainen, PhD, Principal investigator, University of Oulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04083326
- Sponsor's protocol ID
- Icory
- Status last verified
- Nov 2021
- First submitted
- 29 Aug 2019
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Patient Journey Solution for Patients Undergoing Elective Hip and Knee Arthroplasty Due to Primary Osteoarthritis
- ClinicalTrials.gov ID
- NCT04083326
- Acronym / sponsor ID
- Icory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- VTT Technical Research Centre of FinlandUniversity, hospital or other
- Collaborators
- University of Oulu, Oulu University Hospital, Tampere University, Buddy Healthcare Ltd, Solteq Ltd, Near Real Ltd
- Study start
- 4 Sep 2019 (actual)
- Primary completion
- 4 May 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 10 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Patient Journey Solution | Experimental | Device: Digital Patient Journey SolutionPatients 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 | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Patient Journey SolutionPatients 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. | Device | Digital Patient Journey Solution |
Primary outcome
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.
12 secondary outcomes
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
Patient experience post surgery
Time frame: At discharge (1-3 days after the surgery)
Patient experience post intervention
Time frame: 6-8 weeks after TKA or at 8-12 weeks after THA
Application user experience
Time frame: 6-8 weeks after TKA or at 8-12 weeks after THA
Technological self-efficacy
Time frame: At baseline, and 6-8 weeks after TKA or at 8-12 weeks after THA
Self-efficacy regarding preoperative preparation
Time frame: At baseline
Self-efficacy regarding postoperative preparation
Time frame: At discharge (1-3 days after the surgery)
Self-efficacy during postoperative rehabilitation
Time frame: At 1, 3, and 5 weeks after THA/TKA for the intervention group only
Change in Oxford Hip Score (OHS)
Time frame: 60 days prior surgery and 120 days after the surgery
Change Oxford Knee Score (OKS)
Time frame: 60 days prior surgery and 120 days after the surgery
Preoperative adherence
Time frame: From baseline until the date of the surgery for the intervention group only
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Individual participant dataSharing planned: No
Related trials for Primary Elective Hip Arthroplasty (THA)
RecruitingObservational study
Molecular Mechanisms Underlying Hip and Knee Osteoarthritis in Patients Undergoing Primary Elective Arthroplasty
Total Hip Arthroplasty (THA), Total Knee Arthroplasty (TKA)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Minna Pikkarainen, PhD principal investigator
University of Oulu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Patient Journey Solution in people with Primary Elective Hip Arthroplasty (THA) and Primary Elective Total Knee Arthroplasty (TKA), run by VTT Technical Research Centre of Finland at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2021.