- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT03032068
Home Monitoring After Primary Total Knee Arthroplasty
Feasibility of Home Monitoring After Primary Total Knee Arthroplasty
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
Ohio
-
Cleveland, Ohio, Stany Zjednoczone, 44195
- Cleveland Clinic Foundation
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Unilateral primary TKA
- Surgery is performed at Cleveland Clinic Main Campus or at Lutheran Hospital
- Patient must reside within 75 miles (driving distance) from Cleveland Clinic Main Campus
- Patient expected to utilize Cleveland Clinic Home Care Services after surgery
Exclusion Criteria:
- Revision or simultaneous bilateral TKA
- English is not the patient's preferred language for healthcare discussions
- Currently participating in any other research study
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Badania usług zdrowotnych
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
---|---|
Eksperymentalny: At-Home Monitoring
Patients will follow-up in clinic postoperatively at 4, 8, and 12 weeks and their recovery will also be monitored using sensors and communication devices while they are at home after surgery.
|
Patient reported outcomes, functional measures such as the maximum attainable range of motion (AROM) and the number of steps taken will be tracked using sensors worn by the patient.
The AROM sensor values will be verified with range of motion measurements taken using a goniometer during therapy and MD visits.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Overall Reliability of Monitoring Technology, Measured as Proportion of Actual Data Received From the Patient's Home Compared to the Amount of Data Expected (Based on Activities That Were Reported as Completed by Patients) Over the 12 Week Study Period.
Ramy czasowe: daily, from the date of discharge until the 12 week postoperative follow-up appointment has occurred
|
The investigators will determine the reliability of the at-home monitoring technology for recording and transmitting data from the patient's home to the healthcare provider. This will be measured for each patient individually and then combined to form an aggregate measurement. Reliability of the technology to collect data was calculated for each patient individually by counting the number of times data (range of motion, TUG test results, VAS Pain score, etc) was received and dividing that number by the number of times data was expected (activities reported as complete by patients). This was then converted into a percentage. Additionally, this number was aggregated by combining the numerators (activities received) for all patients and denominators (activities complete) for all patients and determining the overall reliability of the technology. |
daily, from the date of discharge until the 12 week postoperative follow-up appointment has occurred
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Rehab Compliance
Ramy czasowe: Percentage of exercises completed 2-3 times daily, from the date of discharge up to approximately 4 weeks postoperatively when outpatient physical therapy begins
|
Percentage of required at-home therapy exercises completed each session, as well as the total percentage completed during all home therapy sessions
|
Percentage of exercises completed 2-3 times daily, from the date of discharge up to approximately 4 weeks postoperatively when outpatient physical therapy begins
|
Change From Preoperative to Postoperative Knee Range of Motion
Ramy czasowe: Once preoperatively then postoperatively 2-3 times daily from the date of discharge until the 12 week postoperative follow-up appointment has occurred
|
Change from Preoperative to Postoperative Knee Range of Motion, Knee range of motion is recorded daily using sensors above and below the knee.
Please note: only data from sensors is being reported
|
Once preoperatively then postoperatively 2-3 times daily from the date of discharge until the 12 week postoperative follow-up appointment has occurred
|
Change From Preoperative to Postoperative Timed Up and Go Test
Ramy czasowe: Once preoperatively then postoperatively 2-3 times daily from the date of discharge until the 12 week postoperative follow-up appointment has occurred
|
Change from Preoperative to Postoperative Timed Up and Go Test.
The time that a patient takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
This time was recorded electronically by the patient at home using the tablet.
|
Once preoperatively then postoperatively 2-3 times daily from the date of discharge until the 12 week postoperative follow-up appointment has occurred
|
Visual Analog Scale for Pain (Knee-related Pain at Its Worst Over a 24 Hour Period)
Ramy czasowe: Once preoperatively then postoperatively 2-3 times daily from the date of discharge until the 12 week postoperative follow-up appointment has occurred
|
Knee-related pain was measured using a visual analog scale with numeric values added to the line.
Zero (0) is the minimum value and 10 is the maximum value.
A score of 0 indicates no pain and a score of 10 indicates the worst pain imaginable.
|
Once preoperatively then postoperatively 2-3 times daily from the date of discharge until the 12 week postoperative follow-up appointment has occurred
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS Pain
Ramy czasowe: Once preoperatively then postoperatively once weekly from the date of discharge until the 12 week follow-up appointment has occurred
|
We will assess KOOS Pain using 9 questions, each response given a point value from 0 to 4. The sum of these points will total between 0 and 36 points.
This score will be normalized to a 100 point scale where 100 means no pain and 0 is extreme pain.
|
Once preoperatively then postoperatively once weekly from the date of discharge until the 12 week follow-up appointment has occurred
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS PS (Physical Function Short Form)
Ramy czasowe: Once preoperatively then postoperatively once weekly from the date of discharge until the 12 week follow-up appointment has occurred
|
We will assess KOOS Function using 7 questions, each response given a point value from 0 to 4. The sum of these points will total between 0 and 28 points.
This total will be normalized to a 100 point scale where 100 means no functional difficulty and 0 is extreme difficulty.
|
Once preoperatively then postoperatively once weekly from the date of discharge until the 12 week follow-up appointment has occurred
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS QOL
Ramy czasowe: Once preoperatively then postoperatively once weekly from the date of discharge until the 12 week follow-up appointment has occurred
|
We will assess KOOS QOL using 4 questions, each response given a point value from 0 to 4. The sum of these points will total between 0 and 16 points, which will then be normalized to a 100 point scale.
One hundred (100) means the knee does not affect quality of life and 0 indicates that the knee is a constant problem affecting quality of life.
|
Once preoperatively then postoperatively once weekly from the date of discharge until the 12 week follow-up appointment has occurred
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Carlos Higuera, MD, Staff Surgeon
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 15-1051
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
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 .
Badania kliniczne na Choroba zwyrodnieniowa stawów, kolano
-
Smith & Nephew, Inc.Nor Consult, LLCZakończonyJourney II XR Total Knee SystemStany Zjednoczone
-
Smith & Nephew, Inc.ZakończonyJourney II BCS Total Knee SystemStany Zjednoczone, Belgia, Nowa Zelandia
-
Smith & Nephew, Inc.Nor ConsultZakończonyJourney II CR Total Knee SystemStany Zjednoczone
Badania kliniczne na At-Home Monitoring
-
University Hospital, LimogesRekrutacyjnyChoroby HematologiczneFrancja
-
Biotronik FranceBiotronik SE & Co. KGZakończonyCzęstoskurcz | DefibrylatoryFrancja
-
NYU Langone HealthZakończony
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Zakończony
-
University Health Network, TorontoSunnybrook Health Sciences Centre; University of TorontoAktywny, nie rekrutujący
-
University of North Carolina, Chapel HillNational Institute of Nursing Research (NINR)ZakończonySłabość | Starzenie się | Opiekunowie | Opieka przejściowa | Wypis pacjentaStany Zjednoczone
-
Centre Hospitalier Régional Metz-ThionvilleRekrutacyjnyZaćma | Implant soczewki wewnątrzgałkowejFrancja
-
University Health Network, TorontoRekrutacyjnyChłoniak | Zaburzenia limfoproliferacyjne | Rak Piersi Stopień I | Rak Piersi Etap II | Rak jelita grubego, stadium II | Rak jelita grubego Stadium III | Rak Piersi Stadium III | Rak jelita grubego Stadium I | Rak Głowy i Szyi Stopień III | Rak piersi, stadium 0 | Rak Głowy i Szyi Stopień I | Rak głowy i szyi w stadium...Kanada
-
Alberto PilottoZakończonyWielochorobowe i wielochorobowe osoby starszeWłochy