Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a pilot randomized controlled trial, comparing a group of older patients with standardized non-pharmacological delirium prevention plus a basic tablet versus a group with standardized non-pharmacological delirium prevention plus a tablet with a software of cognitive stimulation (PREVEDEL).
Software:It is a local development, including a interprofessional team of delirium healthcare experts, older patients and a team og engineers. The software was developed during the first year of this project and was inscribed for author rights.
Inclusion criteria: Older patients > 65 y.o. Admitted to medicine room or intermediate care unit > 48 hrs, and informed consent to participate.
Exclusion Criteria:Delirium positive, neuroleptic use, dementia, and non-spanish speakers.
The study was approved by ethical committee of Hospital Clinico University of Chile Standardized Non-pharmacological intervention: Health workers were previously educated in delirium, and environmental issues were implemented. This intervention coverage in nine different domains: orientation, early mobilization, environmental noise and light, sensorial deficit, sleep, hydratation, drug reduction, and family participation.
Intervention: All patients will have a tablet with or without the software PREVEDEL between 09:00-19:00 hrs.
Measures: delirium will be monitoring with CAM (Confusion Assessment Method) twice a day for 5 days.
Primary outcome: Delirium rate between both groups Secondary outcomes:Long of stay, severity od delirium, time of use of electronic device, and Barthel to discharge.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Patients who meet the inclusion / exclusion criteria will be randomly assigned to the Control group: They will continue to receive the standard prevention measures: delirium detection, treatment health team education and the patient's family, sleep hygiene plan, early mobilization , resolve sensorial deterioration, and delivery of information of temporal-spatial reorientation in a continuous manner, plus the use of a mobile device without installed delirium prevention software (placebo). |
|
| Experimental | Experimental | Patients who meet the inclusion / exclusion criteria will be randomly assigned to the experimental group:They will continue to receive standard prevention measures: Detection of delirium, education of health care team and the patient's family, sleep hygiene plan, early mobilization, resolve sensory impairments, and delivery of information of temporal-spatial reorientation in continuously, plus the use of software installed on a mobile device designed to support the prevention of delirium (Prevention software). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prevention software | Other | All patients will have a tablet with the software PREVEDEL between 09:00-19:00 hrs. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in delirium incidence between both groups | Delirium will be assessed with CAM (the confusion assessment method) twice a day. | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay | The days of total hospital stay of the patients will be recorded | 5 days |
| Severity of delirium | Delirium will be evaluated with CAM-S (the confusion assessment method Severity) whenever appropriate. |
Not provided
Inclusion Criteria:
Older patients > 65 y.o. Admitted to medicine room or intermediate care unit > 48 hrs, and informed consent to participate.
Exclusion Criteria:
Delirium positive, neuroleptic use, dementia, and non-spanish speakers.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eduardo A Tobar, MD | University of Chile | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnico Universidad de Chile | Santiago | International | 6677 | Chile |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | All patients will have a tablet without the software PREVEDEL between 09:00-19:00 hrs. |
|
| 5 days |
| Time of use of electronic device | The usage time on the mobile device (with internal device registration) will be recorded. | 5 days |
| Functionality at discharge. | Functionality at discharge will be assessed with Barthel Index test at discharge. | 5 days |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |