- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Ohio
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Cleveland, Ohio, Estados Unidos, 44106
- Seidman Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: 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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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Perceived risk for falls grouped according to the nurses assessment of risk using the University Hospitals (UH) Falls Assessment Tool
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Relationship between patients perceived risk for falls and nurses risk assessments
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Megan Kuhlenschmidt, Case Comprehensive Cancer Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CASE18Z13
- P30CA043703 (Subvención/contrato del NIH de EE. UU.)
- NCI-2014-00388 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- CASE 18Z13 (Otro identificador: Case Comprehensive Cancer Center)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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