DeliriumNCT01555996
Early Occupational Therapy for Delirium Prevention in Older Patients Admitted to Critical Care Unit
A study testing Early and Intensive Occupational Therapy and Standard non-pharmacological delirium prevention in people with Delirium and Alteration of Cognitive Function, run by University of Chile at 1 site in Chile.
Trial summary
This is a randomized, controlled trial to compare the efficacy of two strategies of non-pharmacological prevention of delirium in critically non-ventilated older patients: standard non-pharmacological prevention intensive nonpharmacological prevention (standard non-pharmacological prevention plus early and intensive… Read more about this study
- Who is it for?
- Ages 60 to 95 years
- Conditions the study is for
- Delirium, Alteration of Cognitive Function, Incompetence, Functional
- What is being tested?
- Early and Intensive Occupational Therapy and Standard non-pharmacological delirium prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteChile
- Study dates
- Apr 2011to Dec 2012
- 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 60 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 60 years.
- Admission to CCU for monitoring by acute or chronic illness, expected more than 24 hours
- Informed consent of patient or family related.
Who cannot join
- Cognitive impairment before to admission (measured by Test Reporter-TIN).
- Severe disorder of communication and cultural constraint of language (inhability of properly communicating in Spanish)
- Delirium at CCU admission or at the beginning of the intervention
- Need for mechanical ventilation
- Early limitation of therapeutic efforts and greater comorbidity with expected mortality within 90 days (in the opinion of the treating team).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Occupational Therapy (OT) for Delirium Prevention in Older Patients Admitted to Critical Care Unit (CCU)
This is a randomized, controlled trial to compare the efficacy of two strategies of non-pharmacological prevention of delirium in critically non-ventilated older patients:
- standard non-pharmacological prevention
- intensive nonpharmacological prevention (standard non-pharmacological prevention plus early and intensive occupational therapy).
Read the detailed description
Delirium is a complication in older, with incidences 70-87% in CCU. This increases mortality, hospital stay, hospital cost, and cognitive impairment. Occupational Therapy (OT) improves independence at discharge, and reduction in delirium in patients undergoing mechanical ventilation. This study compares the efficacy of non pharmacological standard prevention (control group) versus intensive nonpharmacological prevention (experimental group) in the delirium duration in older admitted CCU.
- Being tested
- Early and Intensive Occupational Therapy, Standard non-pharmacological delirium prevention
- Keywords
- older, delirium, cognitive status, occupational therapy, critically ill patients
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early and Intensive Occupational TherapyBehavioural
Also called Active hospital routine
Intervention group:Standard non-pharmacological prevention plus early and intensive OT. Begin in the first 24 hours in CCU admission. OT areas:1)Multi-sensory stimulation:Intense external stimulation, increase alertness,2)Positioning: Fixtures like dorxi-flexion splints, devices for preventing edema,etc,3)Cognitive Stimulation: Awareness, orientation, attention, memory, calculation, praxis and language,4)Training Activities of Daily Living (ADL): Keep a daily routine and independence in hygiene, grooming and feeding,5)Upper Limb Motor Stimulation (ULMS): Activate functional movement and strength ,6)Family involvement.
General Guidelines for intervention: Visit of an OT twice a day, 40 minutes each time, for 5 days; meeting of family training for promote strategies during the daily visit.
Standard non-pharmacological delirium preventionBehavioural
Also called Recommended non-pharmacological treatment
Non-pharmacological strategies are the first line of approach in the prevention of delirium. It is recommended to implement some of these strategies, which are: Reorientation protocol, including information 4 times a day about time, date, place and reason for hospitalization; early mobilization by physical therapist 3 times a day, corrected sensory impairment (use such as eyeglasses, hearing aids); environment management, use clock and calendar in the patient´s room, promote supervision of a professional or family to avoid physical restraints; sleep protocol, like lower light, noise and nighttime drug administration and finally, reduction of any anticholinergic drugs and minimize the use of benzodiazepines.
| Study group | Role | What they receive |
|---|---|---|
| Early and intensive OT | Experimental | Not described Receives: Behavioral: Early and Intensive Occupational Therapy |
| Standard non-pharmacological prevention | Active comparator | Not described Receives: Behavioral: Standard non-pharmacological delirium prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate Delirium duration
Twice a day evaluation for delirium with CAM instrument, for 5 days from enrollment
Measured: From second until sixth days hospitalization
Secondary outcomes (4)
Delirium incidence
Proportion of patients in each arm, to developed delirium during daily evaluation
Measured: From second until sixth days hospitalization
Functional independence
Comparing performance of Activity Daily Living (ADL) at hospital discharge compared to baseline, using FIM (Functional Independence Measure) instrument
Measured: To seventh day of hospitalization and 72 hours before discharge
Strenght of Grip evaluation
Strength of grip by Jamar Dynamometer, is evaluated to hospitalary discharge
Measured: To seventh day of hospitalization and 72 hours before discharge
Cognitive State
MMSE (Mini-Mental State Examination), evaluates cognitive state at hospital discharge
Measured: To seventh day of hospitalization and 72 hours before discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2012 (estimated)
- Study startApr 2011
- Primary completionJul 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Fondo Nacional de Desarrollo Científico y Tecnológico, Chile, National Fund for Research and Development in Health, Chile
- Responsible party
- Principal investigator, Evelyn Alvarez Espinoza, OT, Principal Investigator, University of Chile
- Investigators
- Evelyn Alvarez, Principal investigator, University of ChileMaricel Garrido, Study chair, University of ChileEduardo Tobar, Study chair, University of ChileRolando Aranda, Study chair, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01555996
- Sponsor's protocol ID
- SA10I20015
- Status last verified
- May 2014
- First submitted
- 10 Jan 2012
- Last updated
- 21 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Occupational Therapy (OT) for Delirium Prevention in Older Patients Admitted to Critical Care Unit (CCU)
- ClinicalTrials.gov ID
- NCT01555996
- Acronym / sponsor ID
- SA10I20015
- Keywords
- older, delirium, cognitive status, occupational therapy, critically ill patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Collaborators
- Fondo Nacional de Desarrollo Científico y Tecnológico, Chile, National Fund for Research and Development in Health, Chile
- Study start
- Apr 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 16 Mar 2012 (estimated)
- 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 is a randomized, controlled trial to compare the efficacy of two strategies of non-pharmacological prevention of delirium in critically non-ventilated older patients:
- standard non-pharmacological prevention
- intensive nonpharmacological prevention (standard non-pharmacological prevention plus early and intensive occupational therapy).
Detailed description
Delirium is a complication in older, with incidences 70-87% in CCU. This increases mortality, hospital stay, hospital cost, and cognitive impairment. Occupational Therapy (OT) improves independence at discharge, and reduction in delirium in patients undergoing mechanical ventilation. This study compares the efficacy of non pharmacological standard prevention (control group) versus intensive nonpharmacological prevention (experimental group) in the delirium duration in older admitted CCU.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early and intensive OT | Experimental | Behavioral: Early and Intensive Occupational Therapy |
| Standard non-pharmacological prevention | Active comparator | Behavioral: Standard non-pharmacological delirium prevention |
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age over 60 years.
- Admission to CCU for monitoring by acute or chronic illness, expected more than 24 hours
- Informed consent of patient or family related.
Key exclusion criteria (5 listed)
- Cognitive impairment before to admission (measured by Test Reporter-TIN).
- Severe disorder of communication and cultural constraint of language (inhability of properly communicating in Spanish)
- Delirium at CCU admission or at the beginning of the intervention
- Need for mechanical ventilation
- Early limitation of therapeutic efforts and greater comorbidity with expected mortality within 90 days (in the opinion of the treating team).
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 |
|---|---|---|
| Early and Intensive Occupational TherapyAlso: Active hospital routineIntervention group:Standard non-pharmacological prevention plus early and intensive OT. Begin in the first 24 hours in CCU admission. OT areas:1)Multi-sensory stimulation:Intense external stimulation, increase alertness,2)Positioning: Fixtures like dorxi-flexion splints, devices for preventing edema,etc,3)Cognitive Stimulation: Awareness, orientation, attention, memory, calculation, praxis and language,4)Training Activities of Daily Living (ADL): Keep a daily routine and independence in hygiene, grooming and feeding,5)Upper Limb Motor Stimulation (ULMS): Activate functional movement and strength ,6)Family involvement. General Guidelines for intervention: Visit of an OT twice a day, 40 minutes each time, for 5 days; meeting of family training for promote strategies during the daily visit. | Behavioural | Early and intensive OT |
| Standard non-pharmacological delirium preventionAlso: Recommended non-pharmacological treatmentNon-pharmacological strategies are the first line of approach in the prevention of delirium. It is recommended to implement some of these strategies, which are: Reorientation protocol, including information 4 times a day about time, date, place and reason for hospitalization; early mobilization by physical therapist 3 times a day, corrected sensory impairment (use such as eyeglasses, hearing aids); environment management, use clock and calendar in the patient´s room, promote supervision of a professional or family to avoid physical restraints; sleep protocol, like lower light, noise and nighttime drug administration and finally, reduction of any anticholinergic drugs and minimize the use of benzodiazepines. | Behavioural | Standard non-pharmacological prevention |
Primary outcome
To evaluate Delirium duration
Time frame: From second until sixth days hospitalization
Twice a day evaluation for delirium with CAM instrument, for 5 days from enrollment
4 secondary outcomes
Delirium incidence
Time frame: From second until sixth days hospitalization
Functional independence
Time frame: To seventh day of hospitalization and 72 hours before discharge
Strenght of Grip evaluation
Time frame: To seventh day of hospitalization and 72 hours before discharge
Cognitive State
Time frame: To seventh day of hospitalization and 72 hours before discharge
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 21 May 2014.
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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.
Evelyn Alvarez principal investigator
University of Chile
Maricel Garrido study chair
University of Chile
Eduardo Tobar study chair
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 Early and Intensive Occupational Therapy and Standard non-pharmacological delirium prevention in people with Delirium and Alteration of Cognitive Function, 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 3 inclusion and 5 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 21 May 2014. 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. 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?
To evaluate Delirium duration (time frame: From second until sixth days hospitalization). 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 21 May 2014.