Development and Measurement of the Effects of a Digital Education Solution for Patients Undergoing Total Hip or Knee Arthroplasty

Обзор

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 Participation is voluntary and can be withdrawn at any time.

Подробное описание

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.

Вмешательства

• Поведенческое Digital Preoperative Education with CHUVeduc@home
  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: * Educational modules covering postoperative recovery, pain management, rehabilitation, and discharge planning. * Quizzes and knowledge tests to reinforce patient understanding. * Practical advice sheets for concrete preparation. * Indiv
• Поведенческое Standard Care Pathway
  The main steps include: * Consultation with the surgeon * Group information session * Preoperative consultation * Hospital stay for surgery * Discharge and return home * Telemonitoring with CHUV@home after surgery * Postoperative follow-up visit at 6 weeks 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.

Первичные конечные точки

• Number of patient calls to the remote care center (CTS) [Срок оценки: During the intervention period (from inclusion until surgery, up to 6 weeks)]
• Reason for contacts, the severity of alerts [Срок оценки: During the intervention period (from inclusion until surgery, up to 6 weeks)]

Вторичные конечные точки (12)

• Patient-reported health status and quality of life (EQ-5D-5L) [Срок оценки: At preadmission (3 days before surgery), and 6 weeks postoperatively]
• Patient satisfaction (ANQ questionnaire) [Срок оценки: 1 week after hospital discharge]
• Patient engagement (Patient Activation Measure [PAM-13] [Срок оценки: At baseline during the intervention period , at preadmission (3 days before surgery) and 6 weeks postoperatively]
• Physical activity (International Physical Activity Questionnaire [IPAQ]) [Срок оценки: At baseline during the intervention period and 6 weeks postoperatively]
• Fear and anxiety related to surgery (Survey of Surgical Fear [SSF]) [Срок оценки: At baseline during the intervention period and at preadmission (3 days before surgery)]
• Pain (Numeric Rating Scale for pain) [Срок оценки: At hospital discharge (Day 3-5) and at 6 weeks postoperatively]
• Patients' expectations regarding surgery outcomes (Hospital for Special Surgery Knee/Hip Expectations Survey [HSS Knee or Hip]) [Срок оценки: At baseline (prior to surgery) during the intervention period]
• Qualitative analysis of patient messages to the remote care team (CTS) [Срок оценки: During the intervention period (from inclusion until surgery, up to 12 weeks)]
• Patient-reported Oxford Knee Score [OKS] or Oxford Hip Score [OHS]) [Срок оценки: At preadmission (3 days before surgery) and 6 weeks postoperatively]
• Patient satisfaction with mobile application (uMARS scale) [Срок оценки: At preadmission (3 days before surgery)]
• Health literacy, French eHealth Literacy Scale [F-eHEALS]) [Срок оценки: At baseline during the intervention period and 6 weeks postoperatively]
• Postoperative complications (clinical assessment) [Срок оценки: At hospital discharge (Day 3-5) and at 6 weeks postoperatively]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Швейцария · 1 центр

• University Hospital of Lausanne CHUV — Lausanne

Публикации

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• 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. PMID 25051597
• 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. PMID 29453605
• 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. PMID 27287964
• 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. PMID 31663402

Идентификаторы

NCT: NCT07345299 · CHUVeduc@home

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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