- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Ohio
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Cleveland, Ohio, Stati Uniti, 44106
- Seidman Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
Receive 2 minute video-assisted intervention on the risk and prevention of falls with tailored hand-outs depending on participant answers about fall risks
|
|
Comparatore attivo: 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.
|
Patient are given a generic handout on falling and receive standard care by nurses comprising of a fall risk assessment and verbal education
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Perceived risk for falls grouped according to the nurses assessment of risk using the University Hospitals (UH) Falls Assessment Tool
Lasso di tempo: Up to 8 weeks
|
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.
|
Up to 8 weeks
|
|
Confidence to minimize falls assessed using the UH Falls Assessment Tool and the investigator-constructed Perceived Risk Survey (Nurse version)
Lasso di tempo: Up to 8 weeks
|
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.
|
Up to 8 weeks
|
|
Willingness to call for assistance
Lasso di tempo: Up to 8 weeks
|
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.
|
Up to 8 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Relationship between patients perceived risk for falls and nurses risk assessments
Lasso di tempo: Up to 8 weeks
|
Descriptive statistics will be used to compare scores self-perceived risks of falling with a nurse's assessment of a patient falling
|
Up to 8 weeks
|
|
Patient's satisfaction of the intervention using the final questions on the Perceived Risk Post-Survey
Lasso di tempo: Up to 8 weeks
|
Descriptive statistics will be used by the distribution of pre vs post perceived risk values.
|
Up to 8 weeks
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Megan Kuhlenschmidt, Case Comprehensive Cancer Center
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CASE18Z13
- P30CA043703 (Sovvenzione/contratto NIH degli Stati Uniti)
- NCI-2014-00388 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
- CASE 18Z13 (Altro identificatore: Case Comprehensive Cancer Center)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .