- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02081794
Tailoring Patient Education to Perceived Risk for Falls in Hospitalized Oncology Patients
Tailoring Patient Education to Perceived Risk for Falls in Hospitalized Oncology Patients: A Pilot Study
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
PRIMARY OBJECTIVES:
I. To evaluate the effect of a tailored, nurse-delivered intervention, as compared to the control group, on perceived risk for falls in hospitalized hematology-oncology patients.
II. To evaluate the effect of a tailored, nurse-delivered intervention, as compared to the control group, on confidence to minimize falls in hospitalized hematology-oncology patients.
III. To evaluate the relationship between patients' perceived risk for falling and their willingness to call for assistance with ambulation.
SECONDARY OBJECTIVES:
I. To evaluate the relationship between patients' perceived risk for falls and nursing risk assessments when using the standard hospital assessment tool and the investigator-designed perceived risk survey.
II. To evaluate the relationship between a patients' perceived risk for falls and sustaining a fall.
III. To evaluate patient satisfaction with the intervention.
OUTLINE:
All participants complete the Perceived Risk Survey comprising the participants' perceived risk for falls, their confidence to prevent a fall, and their willingness to ask for assistance at baseline and at 24 and 72 hours (or at discharge if stay is less than 72 hours) post-intervention. Patients are then randomized to 1 of 2 arms.
ARM I: Participants receive tailored education comprising one of four two-minute videos determined by which educational group the participant is placed in: high risk/high perception, high risk/low perception, low risk/high perception, or low risk/low perception. Participants also receive printed education sheets based on the participants' answers given on the Perceived Risk Survey and are tailored to the participants' perception of falls risk.
ARM II: Participants receive a generic educational instruction sheet on falls prevention and receive standard care by nurses comprising a falls risk assessment and verbal education.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Ohio
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Cleveland, Ohio, Stany Zjednoczone, 44106
- Seidman Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Diagnosis of cancer
- Admitted to the third floor of Seidman Cancer Center (SCC)
- Cognitively intact (alert, oriented to self, place, and time, and able to participate in the intervention)
- Ability to speak, read, and comprehend English
Exclusion Criteria:
- Nonmalignant diagnosis
- Actively dying
- Patients with a physician order for bed rest
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Arm I (Tailored education intervention)
Participants receive a tailored educational intervention on the risk of falls comprising one of four two-minute videos determined by which educational group the participant is placed in: high risk/high perception, high risk/low perception, low risk/high perception, or low risk/low perception.
Participants also receive tailored printed educational information concerning hospital falls based on the participants' answers given on the Perceived Risk Survey and are tailored to the participants' perception of falls risk.
Participants also complete an investigator-constructed satisfaction survey at 24 and 72 hours post-intervention.
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Receive 2 minute video-assisted intervention on the risk and prevention of falls with tailored hand-outs depending on participant answers about fall risks
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Aktywny komparator: Arm II (standard fall care)
Participants receive standard care by nurses comprising a falls risk assessment and verbal education and receive an educational instruction sheet on falls prevention.
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Patient are given a generic handout on falling and receive standard care by nurses comprising of a fall risk assessment and verbal education
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Perceived risk for falls grouped according to the nurses assessment of risk using the University Hospitals (UH) Falls Assessment Tool
Ramy czasowe: Up to 8 weeks
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Changes in pre vs post survey for the High Risk/Low Perception group will be compared to all others using a paired McNemar's test for both those receiving the intervention and controls.
Pre and post scores will be compared between those receiving the intervention and controls using chi square tests.
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Up to 8 weeks
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Confidence to minimize falls assessed using the UH Falls Assessment Tool and the investigator-constructed Perceived Risk Survey (Nurse version)
Ramy czasowe: Up to 8 weeks
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Pre vs post survey changes will be compared in confidence group using a paired McNemar's test for both those receiving the intervention and controls.
Pre and post scores will be compared between those receiving the intervention and controls using chi square tests.
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Up to 8 weeks
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Willingness to call for assistance
Ramy czasowe: Up to 8 weeks
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An eight-point Likert scale will be used.
Pre vs post survey changes in willingness group will be compared using a paired McNemars test.
Relationship between Risk/Perception group status and Willingness group will be assessed using a chi-square test stratified by pre or post survey results for both those receiving the intervention and controls.
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Up to 8 weeks
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Relationship between patients perceived risk for falls and nurses risk assessments
Ramy czasowe: Up to 8 weeks
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Descriptive statistics will be used to compare scores self-perceived risks of falling with a nurse's assessment of a patient falling
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Up to 8 weeks
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Patient's satisfaction of the intervention using the final questions on the Perceived Risk Post-Survey
Ramy czasowe: Up to 8 weeks
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Descriptive statistics will be used by the distribution of pre vs post perceived risk values.
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Up to 8 weeks
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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Megan Kuhlenschmidt, Case Comprehensive Cancer Center
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 (Oszacować)
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
- CASE18Z13
- P30CA043703 (Grant/umowa NIH USA)
- NCI-2014-00388 (Identyfikator rejestru: CTRP (Clinical Trial Reporting Program))
- CASE 18Z13 (Inny identyfikator: Case Comprehensive Cancer Center)
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