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Digitally Supported Short-Term Prehabilitation Before Total Knee Replacement (P2R-KneeTEP)

13 lipca 2026 zaktualizowane przez: Ludwig Boltzmann Institute for Digital Health and Prevention

Prehab2Rehab: Digitally Supported Short-Term Prehabilitation Before Total Knee Replacement - A Randomized Controlled Feasibility Trial

This study evaluates the feasibility of a short-term, digitally supported prehabilitation program for patients scheduled for elective total knee replacement (TKR). Osteoarthritis is a leading cause of disability, and recovery following TKR remains heterogeneous, with a substantial proportion of patients experiencing delayed functional recovery. Prehabilitation may improve perioperative outcomes, but its implementation is often limited by short preoperative time windows.

The Prehab2Rehab-KneeTEP trial is a single-center, two-arm, randomized controlled feasibility study conducted in Austria. Patients will be randomized (1:1) to either a multimodal video-supported prehabilitation program or usual care. The intervention consists of a 10 to 14-day preoperative exercise program including strength, endurance, coordination, and gait training, supported by a digital application, and is complemented by a digitally supported transition phase after hospital discharge until the start of inpatient rehabilitation.

The primary objective is to assess feasibility in terms of recruitment, retention, adherence, fidelity, acceptability, and safety. Secondary exploratory outcomes include clinical recovery indicators, functional performance, and patient-reported outcomes assessed across the perioperative pathway.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

Total knee replacement (TKR) is an effective treatment for advanced knee osteoarthritis, yet postoperative recovery remains heterogeneous, with a substantial proportion of patients experiencing persistent functional limitations. Prehabilitation has the potential to optimize patients' physical and psychological readiness before surgery. However, in clinical practice, prehabilitation is often constrained by limited time between surgical indication and procedure. Digitally supported interventions may offer a feasible solution to deliver structured programs within short timeframes while supporting continuity of care across the perioperative pathway.

The Prehab2Rehab-KneeTEP trial is a single-center, randomized, two-arm feasibility study conducted at the Medizinisches Zentrum Bad Vigaun, Austria. The study aims to evaluate the feasibility, acceptability, and safety of a short-term, digitally supported prehabilitation intervention in patients scheduled for elective TKR.

Eligible patients with advanced knee osteoarthritis will be randomized in a 1:1 ratio following baseline assessment (PRE1) to either (i) a multimodal video-supported prehabilitation intervention with an additional digitally supported transition phase or (ii) usual care. Randomization will be performed using computer-generated permuted blocks with stratification for sex and baseline functional capacity assessed by the 6-minute walk test.

The intervention consists of a 10 to 14-day prehabilitation phase prior to surgery, including endurance, resistance, coordination, and gait training. The program is delivered through a combination of in-person instruction and home-based training supported by a digital application (aktivplan), which provides structured exercise guidance and enables documentation of adherence. A teleconsultation via a secure video platform (CAATS) is conducted to ensure exercise safety, provide feedback, and support progression. Sensor-based systems may be used for documentation and research-related measurements but are not used for clinical decision-making.

Following surgery and hospital discharge, participants in the intervention group enter a digitally supported transition phase lasting approximately 10 to 14 days until the start of inpatient rehabilitation (REH1). During this period, patients receive low-threshold exercise guidance and educational content via the digital application to support early recovery, maintain mobility, and promote self-efficacy. Participants in both groups receive standard surgical care and standardized inpatient rehabilitation according to institutional and national guidelines.

The total study participation duration is approximately 47 to 61 days, covering prehabilitation, hospital stay, transition, and rehabilitation phases. Outcomes are assessed at predefined time points along the perioperative pathway, including baseline (PRE1), end of prehabilitation (PRE2), hospital discharge, start of rehabilitation (REH1), and end of rehabilitation (REH2).

The primary objective is to assess feasibility across multiple domains, including recruitment, retention, adherence, fidelity, acceptability, usability of digital tools, and safety. Feasibility outcomes will be evaluated descriptively across process, resource, management, and participant engagement domains.

Secondary objectives are exploratory and include the assessment of clinical recovery indicators such as length of hospital stay, complication rate, and readmission rate, as well as patient-reported outcomes, anthropometric and body composition parameters, and functional performance measures. Given the feasibility nature of the trial, analyses will be descriptive and hypothesis-generating, without confirmatory statistical testing.

The findings of this study will inform the design and implementation of a future adequately powered randomized controlled trial evaluating the effectiveness of digitally supported prehabilitation in patients undergoing total knee replacement

Typ studiów

Interwencyjne

Zapisy (Szacowany)

60

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Austria
    • State of Salzburg
      • Hallein, State of Salzburg, Austria, 5424
        • Medizinisches Zentrum Bad Vigaun GmbH & Co. KG
        • Kontakt:
        • Kontakt:
        • Główny śledczy:
          • Hildebert Hutt, Prim. Dr.
        • Główny śledczy:
          • Thomas Hofstädter, Prim. Dr.
        • Pod-śledczy:
          • Josef Sturm, Dr.

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

Eligibility will be determined during the outpatient consultations at the Medical

Center in Bad Vigaun. Patients will be screened against the following criteria:

  • Age ≥18 years at the time of enrolment.
  • Clinically diagnosed with advanced osteoarthritis and with a medical indication for elective TKR.
  • Either a scheduled surgery or a documented intention to undergo TKR within the recruitment period.
  • Elective surgery is scheduled for at least 14 days after enrolment to allow completion of the 10 to 14-day prehabilitation intervention.
  • Physical ability to safely perform the prescribed exercise program, as confirmed by the treating physician.
  • Willingness to participate in a digitally supported training intervention at either the center or home-based.
  • Sufficient digital literacy and access to internet-enabled devices (smartphone, tablet, or computer).
  • Adequate German language proficiency to follow exercise instructions and study procedures.

Exclusion Criteria:

Patients will be excluded if any of the following apply:

  • Pregnancy at the time of enrolment.
  • Emergency, revisional, or non-elective surgery.
  • Surgery scheduled less than 14 days after enrolment.
  • Severe physical impairment or medical contraindication to exercise training (e.g., unstable cardiovascular disease, uncontrolled hypertension, acute musculoskeletal injury).
  • Patients with contraindications outlined in the Medizinisches Leistungsprofil (MLP) 2.0 that preclude rehabilitation and/or surgery.
  • Participation in another clinical study that could interfere with the intervention or study outcomes.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Inny: Usual care
Usual Care (Control). Participants receive standard preoperative, surgical, and postoperative care including standard inpatient rehabilitation without prehabilitation or digital support.
Inny: Usual Care Group
Participants allocated to the usual care group will receive the standard perioperative treatment provided at the study site. This includes preoperative consultation, elective total knee replacement surgery according to institutional standards, and routine postoperative care. After hospital discharge, participants return home until the start of standardized inpatient rehabilitation (Phase II), including interdisciplinary care such as physiotherapy, occupational therapy, medical supervision, and health education. No structured prehabilitation or digitally supported intervention will be provided.
Inne nazwy:
  • Usual Care Control Group
Eksperymentalny: Multimodal Video-Supported Prehabilitation
Multimodal Video-Supported Prehabilitation plus Digitally Supported Transition. Participants receive a 10 to 14-day multimodal prehabilitation program including endurance, resistance, coordination, and gait training, supported by the aktivplan application, one teleconsultation via CAATS, and research sensors for documentation. Digital support continues during the early post-discharge transition phase with low-threshold exercises and educational content until inpatient rehabilitation begins.
Behawioralne: EXERCISE TRAINING WITH OR WITHOUT MEDICATION
A short-term multimodal, video-supported prehabilitation program delivered over 10 to 14 days before surgery, including endurance, resistance, coordination, and gait training with crutches. The intervention is introduced during an in-person session and subsequently performed at home using a digital application to provide structured exercise guidance and support adherence. A single teleconsultation is conducted to ensure safety, provide feedback, and allow individualized progression. In addition, digital support is extended into the early post-discharge transition phase, providing low-threshold exercise guidance and educational content to support mobility, self-efficacy, and continuity of care until the start of inpatient rehabilitation.
Inne nazwy:
  • Multimodal Prehabilitation Program

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Recruitment rate
Ramy czasowe: Continuous throughout the recruitment period (12 months recruitment period)
The recruitment rate will be calculated as the percentage of eligible patients who consent to participate in the study. The reported value will be: (number of enrolled participants / number of eligible patients) × 100%.
Continuous throughout the recruitment period (12 months recruitment period)
Retention Rate
Ramy czasowe: Continuous throughout the data collection period (14 months data collection period)
Retention will be measured as the percentage of enrolled participants who complete all required study procedures. The reported value will be: (number of participants completing the study / number of enrolled participants) × 100%.
Continuous throughout the data collection period (14 months data collection period)
Adherence to the Intervention
Ramy czasowe: During the intervention period (typically 2-4 weeks prior to surgery).
Adherence will be defined as the proportion of prescribed prehabilitation sessions that participants complete. The reported value will be: (number of completed sessions / number of prescribed sessions) × 100%.
During the intervention period (typically 2-4 weeks prior to surgery).
Completeness of Outcome Data
Ramy czasowe: Continuous throughout data collection period (14 months)
Completeness of data will be assessed as the percentage of planned outcome assessments that are successfully completed and available for analysis. The reported value will be: (number of completed assessments / number of planned assessments) × 100%.
Continuous throughout data collection period (14 months)
Acceptability of the Intervention
Ramy czasowe: At discharge from inpatient rehabilitation (REH2, approximately 6 to 8 weeks after surgery)
Acceptability and usability of the digital intervention will be assessed using the mHealth App Usability Questionnaire (MAUQ). The MAUQ evaluates usability, satisfaction, ease of use, and perceived usefulness of mobile health applications. Items are rated on a 7-point Likert scale, ranging from 1 = strongly disagree to 7 = strongly agree. The outcome will be reported as the mean MAUQ score across completed questionnaires, with higher scores indicating greater perceived usability and acceptability.
At discharge from inpatient rehabilitation (REH2, approximately 6 to 8 weeks after surgery)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Health Assessment Questionnaire (HAQ)
Ramy czasowe: Baseline, prehabilitation discharge (10-14 days after baseline, before surgery), rehabilitation admission (3-4 weeks after surgery), rehabilitation discharge (6-8 weeks after surgery).
Patient-reported outcome assessing functional ability in activities of daily living using the HAQ score. The instrument captures disability across multiple domains including dressing, arising, eating, walking, hygiene, reach, grip, and common daily activities. Total HAQ scores range from 0 to 3, with higher scores indicating greater functional impairment and lower functional status. The HAQ is used to evaluate changes in patient-reported functional status across the perioperative pathway.
Baseline, prehabilitation discharge (10-14 days after baseline, before surgery), rehabilitation admission (3-4 weeks after surgery), rehabilitation discharge (6-8 weeks after surgery).
Barthel-Index (BI)
Ramy czasowe: Baseline (prior to intervention), admission to inpatient rehabilitation (3-4 weeks post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery)
Observer-based outcome assessing functional independence in activities of daily living using the Barthel Index (BI). The instrument evaluates performance in domains including feeding, bathing, grooming, dressing, bowel and bladder control, toilet use, transfers, mobility, and stair use. Total BI scores range from 0 to 100, with higher scores indicating greater functional independence and lower dependency. The BI is used to evaluate changes in functional independence across the perioperative pathway.
Baseline (prior to intervention), admission to inpatient rehabilitation (3-4 weeks post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery)
Oxford Knee Score (OKS)
Ramy czasowe: Baseline (prior to intervention) and discharge from inpatient rehabilitation (6-8 weeks post-surgery)
Patient-reported outcome assessing knee-specific pain and functional status using the OKS score. The instrument captures difficulties in activities such as walking, standing, and rising from a seated position. Scores are calculated according to standard OKS procedures, with higher values indicating better knee function and lower symptom burden. The OKS is used to evaluate changes in knee-related symptoms and function across the perioperative pathway.
Baseline (prior to intervention) and discharge from inpatient rehabilitation (6-8 weeks post-surgery)
Patient Health Questionnaire-4 (PHQ-4)
Ramy czasowe: Baseline (prior to intervention), after completion of prehabilitation (10-14 days after baseline, prior to surgery), admission to inpatient rehabilitation (3-4 weeks post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery)
Patient-reported outcome assessing symptoms of anxiety and depression (PHQ-4). Total score ranges from 0 to 12, with higher values indicating greater psychological distress. Used to monitor changes in psychological well-being across the perioperative pathway.
Baseline (prior to intervention), after completion of prehabilitation (10-14 days after baseline, prior to surgery), admission to inpatient rehabilitation (3-4 weeks post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Ramy czasowe: Baseline (prior to intervention), admission to inpatient rehabilitation (3-4 weeks post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Patient-reported outcome assessing knee pain, stiffness, and physical function (WOMAC). Higher scores indicate worse symptoms and functional limitations. Used to evaluate changes across the perioperative rehabilitation pathway.
Baseline (prior to intervention), admission to inpatient rehabilitation (3-4 weeks post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery).
EuroQol-5 Dimensions-5 Levels (EQ- 5D-5L)
Ramy czasowe: Baseline (prior to intervention), after prehab intervention (10-14 days post-baseline)), discharge (6-12 days post-surgery), admission to inpatient rehabilitation (3-4 weeks post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery).
The EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) is a standardized, patient-reported outcome measure assessing health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on five levels of severity. Responses are converted into a health utility index score, with higher values indicating better health status. The instrument also includes a visual analogue scale (EQ-VAS), ranging from 0 to 100, with higher scores indicating better self-rated health.
Baseline (prior to intervention), after prehab intervention (10-14 days post-baseline)), discharge (6-12 days post-surgery), admission to inpatient rehabilitation (3-4 weeks post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Rapid Assessment of Physical Activity (RAPA)
Ramy czasowe: Baseline (prior to intervention), and discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Self-reported questionnaire assessing level of physical activity (RAPA). Scores reflect engagement in aerobic and strength-based physical activity, with higher scores indicating higher activity levels. Used to evaluate changes in physical activity behavior across the perioperative pathway.
Baseline (prior to intervention), and discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Exercise Self-Efficacy Scale (ESES)
Ramy czasowe: Baseline (prior to intervention), after prehab intervention (10-14 days post-baseline), discharge (6-12 days post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Exercise Self-Efficacy Scale (ESES). Self-reported measure assessing confidence in the ability to perform and maintain physical activity. Total scores range from 10 to 40, with higher scores indicating greater exercise self-efficacy and therefore a better outcome. Used to evaluate changes in exercise-related confidence across the perioperative pathway.
Baseline (prior to intervention), after prehab intervention (10-14 days post-baseline), discharge (6-12 days post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Body Fat Mass
Ramy czasowe: Baseline (prior to intervention) and discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Body fat mass measured using bioelectrical impedance analysis (BIA). Body fat mass represents the total amount of body fat and will be reported in kilograms (kg).
Baseline (prior to intervention) and discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Body Lean Mass
Ramy czasowe: Baseline (prior to intervention) and discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Body Lean Mass measured using bioelectrical impedance analysis (BIA). Body Lean Mass represents the total amount of non-fat body tissue and will be reported in kilograms (kg).
Baseline (prior to intervention) and discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Phase Angle
Ramy czasowe: Baseline (prior to intervention) and discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Phase angle measured using bioelectrical impedance analysis (BIA). Phase angle is a marker of cellular integrity and body cell mass and will be reported in degrees (°).
Baseline (prior to intervention) and discharge from inpatient rehabilitation (6-8 weeks post-surgery).
6-Minute Walk Test (6MWT)
Ramy czasowe: Baseline (prior to intervention), admission to inpatient rehabilitation (3-4 weeks post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery).
The 6-Minute Walk Test (6MWT) is used to assess functional exercise capacity. Participants are instructed to walk as far as possible for six minutes along a standardized corridor, with distance covered recorded in meters. Standardized instructions and encouragement are provided according to established guidelines.
Baseline (prior to intervention), admission to inpatient rehabilitation (3-4 weeks post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Timed Up and Go Test (TUG)
Ramy czasowe: Baseline (prior to intervention), after prehab intervention (10-14 days post-baseline), admission to inpatient rehabilitation (3-4 weeks post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery).
The Timed Up and Go Test (TUG) assesses functional mobility. Participants are instructed to stand up from a seated position, walk a short distance, turn, return, and sit down, with the total time recorded in seconds under standardized conditions.
Baseline (prior to intervention), after prehab intervention (10-14 days post-baseline), admission to inpatient rehabilitation (3-4 weeks post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Single-Leg Stance (SLS)
Ramy czasowe: Baseline (prior to intervention), after prehab intervention (10-14 days after baseline), admission to inpatient rehabilitation (3-4 weeks post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery).
The Single-Leg Stance (SLS) test assesses static balance. Participants are instructed to stand on one leg for as long as possible under standardized conditions, with time recorded in seconds.
Baseline (prior to intervention), after prehab intervention (10-14 days after baseline), admission to inpatient rehabilitation (3-4 weeks post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Fifteen-meter Gait Analysis with crutches (15-mGA+)
Ramy czasowe: Baseline (prior to intervention), after prehab intervention (10-14 days post-baseline), admission to inpatient rehabilitation (3-4 weeks post-surgery).
The Fifteen-meter Gait Analysis with crutches (15-mGA+) assesses gait performance under assisted walking conditions. Participants walk a standardized distance of 15 meters using crutches, with performance recorded under standardized conditions.
Baseline (prior to intervention), after prehab intervention (10-14 days post-baseline), admission to inpatient rehabilitation (3-4 weeks post-surgery).
Ten-meter Walk Test without crutches (10-mWT)
Ramy czasowe: Baseline (prior to intervention), after prehab intervention (10-14 days after baseline), discharge from inpatient rehabilitation (6-8 weeks post-surgery).
The Ten-meter Walk Test without crutches (10-mWT) assesses gait speed. Participants are instructed to walk a standardized distance of 10 meters without assistive devices, with time recorded under standardized conditions.
Baseline (prior to intervention), after prehab intervention (10-14 days after baseline), discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Knee Range of Motion (ROM)
Ramy czasowe: Baseline (prior to intervention), discharge (6-12 days post-surgery), admission to inpatient rehabilitation (3-4 weeks post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Knee Range of Motion (ROM) assesses joint mobility. Range of motion of the knee joint is measured in degrees under standardized conditions.
Baseline (prior to intervention), discharge (6-12 days post-surgery), admission to inpatient rehabilitation (3-4 weeks post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Lower limb strength (LLS)
Ramy czasowe: Baseline (prior to intervention), after prehab intervention (10-14 days after baseline), admission to inpatient rehabilitation (3-4 weeks post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Lower limb strength (LLS) assesses muscular strength of the lower extremities. Strength is measured using an isokinetic dynamometer (Biodex) under standardized conditions.
Baseline (prior to intervention), after prehab intervention (10-14 days after baseline), admission to inpatient rehabilitation (3-4 weeks post-surgery), discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Handgrip strength (HG)
Ramy czasowe: Baseline (prior to intervention) and discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Handgrip strength (HG) assesses upper limb muscle strength using a handheld dynamometer under standardized conditions.
Baseline (prior to intervention) and discharge from inpatient rehabilitation (6-8 weeks post-surgery).

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Unified Theory of Acceptance and Use of Technology (UTAUT-2)
Ramy czasowe: At the discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Assesses user acceptance and behavioral intention to use digital health technologies, including perceived usefulness, ease of use, and facilitating conditions.
At the discharge from inpatient rehabilitation (6-8 weeks post-surgery).
mHealth App Usability Questionnaire (MAUQ)
Ramy czasowe: At the discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Usability of the digital intervention will be assessed MAUQ, a validated instrument designed to evaluate usability, ease of use, and satisfaction with mobile health applications. Items are rated on a 7-point Likert scale ranging from 1 = strongly disagree to 7 = strongly agree. Responses are aggregated according to standard scoring procedures to calculate a mean total score, with higher scores indicating greater perceived usability.
At the discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Mobile App Rating Scale (MARS)
Ramy czasowe: At the discharge from inpatient rehabilitation (6-8 weeks post-surgery).
The quality of the mobile health application will be assessed using the Mobile App Rating Scale (MARS). The instrument includes four domains (engagement, functionality, aesthetics, and information quality), but the outcome will be reported as a single composite score calculated as the mean of all MARS items, each rated on a 5-point Likert scale. Total scores range from 1 to 5, with higher scores indicating better perceived app quality.
At the discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Perceived hedonic and pragmatic quality (AttrakDiff)
Ramy czasowe: At the discharge from inpatient rehabilitation (6-8 weeks post-surgery).
The AttrakDiff questionnaire assesses user experience of the digital intervention, including pragmatic quality (usability), hedonic quality (stimulation and identification), and overall attractiveness. Items are rated on a 7-point semantic differential scale ranging from -3 to +3. Scores are aggregated according to standard procedures to calculate overall and subscale scores, with higher values indicating more positive user experience.
At the discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Affinity for Technology Interaction (ATI)
Ramy czasowe: At the discharge from inpatient rehabilitation (6-8 weeks post-surgery).
The Affinity for Technology Interaction (ATI) Scale will be used to measure individuals' tendency to interact with and use technology in daily life. The scale consists of multiple items rated on a 6-point Likert scale (1 = completely disagree to 6 = completely agree). A mean total score will be calculated as the outcome measure. Higher scores indicate greater affinity for technology interaction.
At the discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Structured interviews
Ramy czasowe: At the discharge from inpatient rehabilitation (6-8 weeks post-surgery).
Structured interviews will be conducted to qualitatively explore patient experiences, acceptability, usability, and perceived usefulness of the digitally supported intervention throughout the perioperative pathway. Interview responses will be analyzed descriptively to identify common themes related to patient experiences with the intervention. No numerical score will be calculated.
At the discharge from inpatient rehabilitation (6-8 weeks post-surgery).

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Ludwig Boltzmann Institute for Digital Health and Prevention

Współpracownicy

Paracelsus Medical University
Medizinische Zentrum Bad Vigaun GmbH & Co. KG

Śledczy

  • Dyrektor Studium: Daniela Wurhofer, Dr., Ludwig Boltzmann Institute for Digital Health and Prevention

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

15 lipca 2026

Zakończenie podstawowe (Szacowany)

1 kwietnia 2027

Ukończenie studiów (Szacowany)

1 maja 2027

Daty rejestracji na studia

Pierwszy przesłany

16 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

29 maja 2026

Pierwszy wysłany (Rzeczywisty)

2 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

14 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

13 lipca 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • Prehab2Rehab-KneeTEP
  • Nr.1163/2025 (Inny identyfikator: Ethics Committee of the State of Salzburg)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

Individual participant data (IPD) will not be shared in order to protect participant confidentiality and in accordance with applicable data protection regulations, including the General Data Protection Regulation (GDPR). Only aggregated and fully anonymized data will be reported in scientific publications and presentations. No individual-level data will be made publicly available. Access to underlying data may be considered upon reasonable request and subject to institutional, ethical, and legal approval.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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