Delirium in Old AgePrevedelNCT03573843
Software-guided Cognitive Stimulation to Prevents Delirium
A study testing Prevention software in people with Delirium in Old Age, run by University of Chile at 1 site in Chile.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Delirium in Old Age
- What is being tested?
- Prevention software
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChile
- Study dates
- 15 Jun 2018to 30 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Older patients > 65 y.o. Admitted to medicine room or intermediate care unit > 48 hrs, and informed consent to participate.
Who cannot join
- Delirium positive, neuroleptic use, dementia, and non-spanish speakers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Stimulation Guided by a Software to Prevent Delirium in Older Patients
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.
Read more
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.
- Conditions
- Delirium in Old Age
- Being tested
- Prevention software, Placebo
- Keywords
- Delirium, Prevention, Cognitive stimulation
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevention softwareOther
All patients will have a tablet with the software PREVEDEL between 09:00-19:00 hrs.
PlaceboOther
All patients will have a tablet without the software PREVEDEL between 09:00-19:00 hrs.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: 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). Receives: Other: Prevention software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in delirium incidence between both groups
Delirium will be assessed with CAM (the confusion assessment method) twice a day.
Measured: 5 days
Secondary outcomes (4)
Length of stay
The days of total hospital stay of the patients will be recorded
Measured: 5 days
Severity of delirium
Delirium will be evaluated with CAM-S (the confusion assessment method Severity) whenever appropriate.
Measured: 5 days
Time of use of electronic device
The usage time on the mobile device (with internal device registration) will be recorded.
Measured: 5 days
Functionality at discharge.
Functionality at discharge will be assessed with Barthel Index test at discharge.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start15 Jun 2018
- Primary completion31 Aug 2018
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium in Old AgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eduardo Tobar, University of Chile
- Investigators
- Eduardo A Tobar, MD, Study director, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03573843
- Sponsor's protocol ID
- UCHID16AM0080
- Acronym
- Prevedel
- Status last verified
- Jan 2020
- First submitted
- 4 May 2018
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Stimulation Guided by a Software to Prevent Delirium in Older Patients
- ClinicalTrials.gov ID
- NCT03573843
- Acronym / sponsor ID
- Prevedel / UCHID16AM0080
- Conditions
- Delirium in Old Age
- Keywords
- Delirium, Prevention, Cognitive stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 29 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: PlaceboPatients 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 | Other: Prevention softwarePatients 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). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Older patients > 65 y.o. Admitted to medicine room or intermediate care unit > 48 hrs, and informed consent to participate.
Key exclusion criteria (1 listed)
- Delirium positive, neuroleptic use, dementia, and non-spanish speakers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prevention softwareAll patients will have a tablet with the software PREVEDEL between 09:00-19:00 hrs. | Other | Experimental |
| PlaceboAll patients will have a tablet without the software PREVEDEL between 09:00-19:00 hrs. | Other | Control |
Primary outcome
Difference in delirium incidence between both groups
Time frame: 5 days
Delirium will be assessed with CAM (the confusion assessment method) twice a day.
4 secondary outcomes
Length of stay
Time frame: 5 days
Severity of delirium
Time frame: 5 days
Time of use of electronic device
Time frame: 5 days
Functionality at discharge.
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo A Tobar, MD study director
University of Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevention software in people with Delirium in Old Age, run by University of Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in delirium incidence between both groups (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2020.