Prevedel: Software-guided Cognitive Stimulation to Prevents Delirium

• Sponsor: University of Chile (Other)
• Overall Status: Completed
• CT.gov ID: NCT03573843
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 16.5
• Patients Per Site Per Month: 3.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Delirium in Old Age	Other: Prevention software; Other: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Cognitive Stimulation Guided by a Software to Prevent Delirium in Older Patients
• Actual Study Start Date: Jun 15, 2018
• Actual Primary Completion Date: Aug 31, 2018
• Actual Study Completion Date: Oct 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control 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).	Other: Placebo; All patients will have a tablet without the software PREVEDEL between 09:00-19:00 hrs.
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).	Other: Prevention software; All patients will have a tablet with the software PREVEDEL between 09:00-19:00 hrs.

Outcome Measures

Primary Outcome Measures

1. Difference in delirium incidence between both groups [5 days]

   Delirium will be assessed with CAM (the confusion assessment method) twice a day.

Secondary Outcome Measures

1. Length of stay [5 days]

   The days of total hospital stay of the patients will be recorded

2. Severity of delirium [5 days]

   Delirium will be evaluated with CAM-S (the confusion assessment method Severity) whenever appropriate.

3. Time of use of electronic device [5 days]

   The usage time on the mobile device (with internal device registration) will be recorded.

4. Functionality at discharge. [5 days]

   Functionality at discharge will be assessed with Barthel Index test at discharge.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Clínico Universidad de Chile	Santiago	International	Chile	6677

Sponsors and Collaborators

• University of Chile

Investigators

• Study Director: Eduardo A Tobar, MD, University of Chile

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eduardo Tobar, Associated professor, University of Chile
• ClinicalTrials.gov Identifier: NCT03573843
• Other Study ID Numbers: UCHID16AM0080
• First Posted: Jun 29, 2018
• Last Update Posted: Jan 14, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Eduardo Tobar, Associated professor, University of Chile: Delirium; Prevention; Cognitive stimulation
• Additional relevant MeSH terms: Delirium

Study Results

No Results Posted as of Jan 14, 2020