- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07345299
Development and Measurement of the Effects of a Digital Education Solution for Patients Undergoing Total Hip or Knee Arthroplasty (CHUVeduc@home)
This study aims to evaluate the effectiveness of a digital patient education solution, CHUVeduc@home, in improving preoperative preparation for patients undergoing total hip or knee arthroplasty. In Switzerland, many patients receive joint replacements each year to relieve osteoarthritis-related pain. With shorter hospital stays, adequate preparation before surgery has become increasingly important.
A total of 160 patients will be randomized into two groups:
Intervention group: access to CHUVeduc@home before surgery. Control group: standard preoperative preparation (group information session and consultation).
All participants will complete questionnaires through the application. No additional visits are required. The intervention lasts approximately 12 weeks.
The primary goal is to determine whether digital education increases patient knowledge, confidence, and satisfaction, and facilitates recovery and return home after surgery. Participation is voluntary and can be withdrawn at any time.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Purpose:
The purpose of this study is to improve preparation for hip or knee surgery. Each year in Switzerland, a large number of individuals receive a hip or knee prosthesis to relieve pain caused by osteoarthritis. Through enhanced perioperative care programs such as the one implemented at CHUV, the length of hospital stay has decreased, making preoperative preparation increasingly important.
Current Practice:
Current practice includes participation in a group information session and a preoperative consultation. However, retaining all provided information can be challenging. To support more effective preparation, the investigators will evaluate a digital application called CHUVeduc@home, integrated within CHUV@home, which is already used during postoperative recovery.
Features of the Application:
The application provides the possibility to:
Review information at an individualized pace. Improve understanding of the surgical and recovery processes. Access quizzes and practical information sheets for training purposes.
Submit questions directly to the Telemonitoring Center team.
Study Design:
The study plans to include 160 participants. Participants will be randomly assigned to one of two groups:
A group using the application before surgery. A group following the usual preoperative preparation process.
All participants will use the application to complete study questionnaires. No additional appointments are required. The study duration is approximately 12 weeks. Participation is voluntary and can be discontinued at any time.
Expected Benefits:
The investigators anticipate that this digital approach to preoperative preparation may help participants feel more confident, better informed, and better supported during their return home after surgery.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Claude Pichonnaz, Ph.D
- Phone Number: +41213168126
- Email: claude.pichonnaz@hesav.ch
Study Contact Backup
- Name: Claude Lessert, PT MSc
- Phone Number: +41787746839
- Email: claudia.lessert@hesav.ch
Study Locations
-
-
Canton of Vaud
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Lausanne, Canton of Vaud, Switzerland, 1011
- University Hospital of Lausanne CHUV
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Contact:
- Julien Wegrzyn, Professor
- Phone Number: +4121 314 03 44
- Email: julien.wegrzyn@chuv.ch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- male and female patients admitted to the CHUV musculoskeletal department during the study period
- primary total hip replacement or primary total knee replacement
- a Risk Assessment and Prediction Tool (RAPT) score >6
Exclusion Criteria:
- a RAPT score <6,
- knee/hip arthroplasty revision surgery
- inability to give informed consent or answer questionnaires knowledgeably due to language or cognitive impairment as reported in the medical record
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group: access to CHUVeduc@home before surgery
Intervention Group - Pathway with CHUVeduc@home This group follows the standard preoperative pathway, complemented by personalized digital preparation through the CHUVeduc@home application, available 2 to 6 weeks before surgery.
|
The intervention consists of a personalized digital education program delivered through the CHUVeduc@home mobile application, integrated within the existing CHUV@home platform. The application is available to patients 2 to 6 weeks prior to surgery and provides:
The goal of the intervention is to improve patient health literacy, reduce preoperative anxiety, increase confidence, and facilitate recovery and return home after total hip or knee arthroplasty. |
|
Active Comparator: Control Group - Standard Care Pathway
Control Group - Standard Care Pathway This group follows the standard clinical care pathway established at CHUV for patients undergoing total hip or knee arthroplasty. The main steps include:
Participants in this group also use the CHUV@home application to complete study-specific questionnaires; however, they do not receive any additional educational content prior to surgery. |
The main steps include:
Participants in this group also use the CHUV@home application to complete study-specific questionnaires; however, they do not receive any additional educational content prior to surgery. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of patient calls to the remote care center (CTS)
Time Frame: During the intervention period (from inclusion until surgery, up to 6 weeks)
|
The primary outcome is the total number of calls initiated by patients to the remote care support center (CTS) during the intervention period.
This measure will assess the impact of the digital education tool on patient autonomy and the need for additional support.
A lower number of calls is expected to reflect improved patient preparation and self-management.
|
During the intervention period (from inclusion until surgery, up to 6 weeks)
|
|
Reason for contacts, the severity of alerts
Time Frame: During the intervention period (from inclusion until surgery, up to 6 weeks)
|
This secondary objective aims to analyze the specific reasons for patient contacts, assess the severity of alerts generated, and evaluate the potential financial benefits associated with a decrease in the number of contacts, thereby providing a comprehensive understanding of the impact of the telemonitoring intervention.
|
During the intervention period (from inclusion until surgery, up to 6 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient-reported health status and quality of life (EQ-5D-5L)
Time Frame: At preadmission (3 days before surgery), and 6 weeks postoperatively
|
Generic health-related quality-of-life measure including five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and a visual analogue scale (VAS). Range: Index score: typically ranges from <0 (health states worse than death) to 1 (perfect health). VAS: 0 to 100, where 100 indicates the best imaginable health. Direction: Higher scores reflect better health status. |
At preadmission (3 days before surgery), and 6 weeks postoperatively
|
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Patient satisfaction (ANQ questionnaire)
Time Frame: 1 week after hospital discharge
|
Patient satisfaction with hospital care will be evaluated using the Association Nationale pour la Qualité (ANQ) patient satisfaction questionnaire. The ANQ questionnaire includes multiple items each rated on a Likert scale from 1 to 5, where higher scores indicate greater satisfaction. Depending on the domain structure used locally, total scores typically range from 1 (lowest satisfaction) to 5 (highest satisfaction) per item; domain or global scores are expressed as mean values, with higher values reflecting better satisfaction with care. |
1 week after hospital discharge
|
|
Patient engagement (Patient Activation Measure [PAM-13]
Time Frame: At baseline during the intervention period , at preadmission (3 days before surgery) and 6 weeks postoperatively
|
Patient engagement in disease management and surgical preparation will be assessed using the Patient Activation Measure-13 (PAM-13). The PAM-13 contains 13 items, each scored from 1 (strongly disagree) to 4 (strongly agree). Raw scores are converted to a standardized activation score ranging from 0 to 100. Higher scores indicate greater patient activation, confidence, and involvement in their own health management. Scores classify patients into four activation levels, with Level 1 = lowest activation and Level 4 = highest activation. |
At baseline during the intervention period , at preadmission (3 days before surgery) and 6 weeks postoperatively
|
|
Physical activity (International Physical Activity Questionnaire [IPAQ])
Time Frame: At baseline during the intervention period and 6 weeks postoperatively
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Physical activity levels will be assessed using the International Physical Activity Questionnaire (IPAQ - Short Form). The IPAQ evaluates physical activity performed in the last 7 days across four domains: walking, moderate-intensity activity, vigorous-intensity activity, and sedentary time. Scores are expressed as Metabolic Equivalent of Task (MET)-minutes per week. Total physical activity score typically ranges from 0 MET-min/week (no reported activity) to > 3,000 MET-min/week (very high activity levels). Higher MET-min/week scores indicate higher levels of physical activity. Participants will also be classified into the IPAQ categories: Low physical activity, Moderate physical activity, High physical activity, based on standard IPAQ scoring guidelines. |
At baseline during the intervention period and 6 weeks postoperatively
|
|
Fear and anxiety related to surgery (Survey of Surgical Fear [SSF])
Time Frame: At baseline during the intervention period and at preadmission (3 days before surgery)
|
Fear and anxiety associated with the upcoming surgery will be measured using the Survey of Surgical Fear (SSF). The SSF includes 8 items, each rated from 0 (not at all fearful) to 10 (extremely fearful). Total score range: 0 to 80. The questionnaire provides two subscale scores:
Higher scores indicate higher levels of fear and anxiety related to surgery. |
At baseline during the intervention period and at preadmission (3 days before surgery)
|
|
Pain (Numeric Rating Scale for pain)
Time Frame: At hospital discharge (Day 3-5) and at 6 weeks postoperatively
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Patients will report pain intensity using the Numeric Rating Scale (EVA), during routine follow-up visits.
|
At hospital discharge (Day 3-5) and at 6 weeks postoperatively
|
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Patients' expectations regarding surgery outcomes (Hospital for Special Surgery Knee/Hip Expectations Survey [HSS Knee or Hip])
Time Frame: At baseline (prior to surgery) during the intervention period
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Patient expectations concerning pain relief, mobility, essential daily activities, psychological benefits, and non-essential activities (e.g., sport/leisure) will be measured using the Hospital for Special Surgery (HSS) Knee or Hip Expectations Survey, depending on the type of surgery.
|
At baseline (prior to surgery) during the intervention period
|
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Qualitative analysis of patient messages to the remote care team (CTS)
Time Frame: During the intervention period (from inclusion until surgery, up to 12 weeks)
|
A qualitative review of the messages sent by patients to the remote care support team (CTS) will be performed to identify difficulties encountered during the intervention and the solutions provided.
|
During the intervention period (from inclusion until surgery, up to 12 weeks)
|
|
Patient-reported Oxford Knee Score [OKS] or Oxford Hip Score [OHS])
Time Frame: At preadmission (3 days before surgery) and 6 weeks postoperatively
|
Joint-specific questionnaire assessing knee or hip pain and functional ability after knee or hip surgery. Range: 0 to 48, based on 12 items (0-4 per item). Direction: Higher scores indicate better knee or hip function and less pain. |
At preadmission (3 days before surgery) and 6 weeks postoperatively
|
|
Patient satisfaction with mobile application (uMARS scale)
Time Frame: At preadmission (3 days before surgery)
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Satisfaction with the mobile application will be assessed using the User Version of the Mobile Application Rating Scale (uMARS). The uMARS consists of 20 items rated from 1 to 5, grouped into four objective quality subscales (engagement, functionality, aesthetics, information) and one subjective quality subscale. Subscale and total scores range from 1 (poor quality) to 5 (excellent quality). Higher uMARS scores reflect greater perceived app quality and satisfaction. |
At preadmission (3 days before surgery)
|
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Health literacy, French eHealth Literacy Scale [F-eHEALS])
Time Frame: At baseline during the intervention period and 6 weeks postoperatively
|
Health literacy will be evaluated using the French version of the eHealth Literacy Scale (F-eHEALS). The F-eHEALS contains 8 items, each rated from 1 (strongly disagree) to 5 (strongly agree). Total score range: 8 to 40. Higher scores indicate better perceived eHealth literacy, including ability to find, appraise, and use online health information. |
At baseline during the intervention period and 6 weeks postoperatively
|
|
Postoperative complications (clinical assessment)
Time Frame: At hospital discharge (Day 3-5) and at 6 weeks postoperatively
|
Postoperative complications will be recorded by clinical staff according to routine medical documentation. Outcomes include the presence or absence of complications and the type of complication (e.g., infection, thromboembolic event, wound complication, cardiovascular or respiratory event). This is a categorical clinical outcome (no scoring scale). |
At hospital discharge (Day 3-5) and at 6 weeks postoperatively
|
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Length of stay (days of hospitalization)
Time Frame: At hospital discharge
|
Length of hospital stay, expressed in days, with higher values indicating longer hospitalization.
|
At hospital discharge
|
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Hospital readmission (yes/no)
Time Frame: At 6 weeks postoperatively
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Hospital readmissions within the follow-up period will be recorded by clinical staff. Reported as yes/no, with reason for readmission documented when applicable. This is a binary clinical outcome (no scoring scale). |
At 6 weeks postoperatively
|
|
Stratified analysis of intervention effectiveness by patient characteristics
Time Frame: At the end of the intervention period (up to 12 weeks after inclusion)
|
A stratified analysis will be conducted to evaluate whether the impact of the digital education intervention varies across patient subgroups (e.g., age, education level, comorbidity profile).
This will help identify clusters of patients who benefit most from digital education.
|
At the end of the intervention period (up to 12 weeks after inclusion)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Claude Pichonnaz, Ph.D, Haute Ecole de Santé Vaud
Publications and helpful links
General Publications
- Wainwright TW, Gill M, McDonald DA, Middleton RG, Reed M, Sahota O, Yates P, Ljungqvist O. Consensus statement for perioperative care in total hip replacement and total knee replacement surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Acta Orthop. 2020 Feb;91(1):3-19. doi: 10.1080/17453674.2019.1683790. Epub 2019 Oct 30.
- Stoyanov SR, Hides L, Kavanagh DJ, Wilson H. Development and Validation of the User Version of the Mobile Application Rating Scale (uMARS). JMIR Mhealth Uhealth. 2016 Jun 10;4(2):e72. doi: 10.2196/mhealth.5849.
- Ljungqvist O, Hubner M. Enhanced recovery after surgery-ERAS-principles, practice and feasibility in the elderly. Aging Clin Exp Res. 2018 Mar;30(3):249-252. doi: 10.1007/s40520-018-0905-1. Epub 2018 Feb 16.
- Agri F, Hahnloser D, Demartines N, Hubner M. Gains and limitations of a connected tracking solution in the perioperative follow-up of colorectal surgery patients. Colorectal Dis. 2020 Aug;22(8):959-966. doi: 10.1111/codi.14998. Epub 2020 Feb 27.
- Roulin D, Blanc C, Demartines N, Hubner M. [Enhanced Recovery After Surgery--optimal management of the surgical patient]. Rev Med Suisse. 2014 Jun 18;10(435):1343-7. French.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CHUVeduc@home
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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