DeliriumMAPDINCT01356810
Prophylactic Environmental Management of Delirium
A study testing Environmental Intervention in people with Delirium and Falls, run by Universidad de Valparaiso at 1 site in Chile.
Trial summary
Delirium is a complex neuropsychiatric syndrome with an acute onset and fluctuating course which is presented in 15 to 20% of patients admitted to general wards. It is a potentially life - threatening complication which can be prevented. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- What is being tested?
- Environmental Intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 287 participants
- Where
- 1 siteChile
- Study dates
- Sep 2009to Jun 2010
- 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Above 65 years of age and one of the following:
- Age above 70 years.
- Alcoholism
- Cognitive deficit (Mini mental state examination <24 points)
- Metabolic disturbance (Hyponatremia, Hypernatremia, Hyperkalemia, Hypokalemia Hyperglycemia or Hypoglycemia)
Who cannot join
- Delirium at admission.
- Admittance to a ward other than general internal medicine.
- Lack of family support.
- Informed consent refusal.
- Hospitalization in a room with more than two beds.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Manejo Ambiental Profilactico Del Delirium Intrahospitalario
Delirium is a complex neuropsychiatric syndrome with an acute onset and fluctuating course which is presented in 15 to 20% of patients admitted to general wards. It is a potentially life - threatening complication which can be prevented. It is the objective of this randomized controlled trial to evaluate whether a multicomponent environmental intervention could reduce the incidence of delirium in a general medical ward.
Read the detailed description
A total of 287 patients 65 years of age or older who had been admitted to a general medicine ward and who were at risk of delirium were studied. Eligible patients were randomized to a multicomponent environmental intervention or standard care. Both groups were well balanced in patients characteristics and followed during the full hospital stay by a group trained in the application of the confusion assessment method to detect incident delirium.
- Being tested
- Environmental Intervention, Standard Care
- Keywords
- Delirium, Primary Prevention, Elderly
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Environmental InterventionOther
The environmental intervention consisted of daily reorientation, avoidance of sensorial deprivation, longer visiting hours, the availability of a clock, a calendar and the presence of familiar objects in the room.
Standard CareOther
Delirium management by the attending physician's preferences.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Placebo comparator | Delirium management defined by the attending physician. Receives: Other: Standard Care |
| Environmental Intervention | Experimental | Not described Receives: Other: Environmental Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Delirium
New episodes of delirium during the hospital stay
Measured: Daily during the entire hospital stay (Average: 10 days, Maximum: 42 days)
Secondary outcomes (1)
Incidence of Falls
New episodes of Falls
Measured: Daily during the entire hospital stay (Average: 10 days, Maximum: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2011 (estimated)
- Study startSep 2009
- Primary completionJun 2010
- Study completionJun 2010
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
- Investigator
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Valparaiso
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felipe Martinez, Universidad de Valparaiso
- Investigators
- Felipe T Martinez, MD, Principal investigator, Universidad de Valparaiso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01356810
- Sponsor's protocol ID
- P06/11
- Acronym
- MAPDI
- Status last verified
- Jan 2019
- First submitted
- 16 May 2011
- Last updated
- 29 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manejo Ambiental Profilactico Del Delirium Intrahospitalario
- ClinicalTrials.gov ID
- NCT01356810
- Acronym / sponsor ID
- MAPDI / P06/11
- Keywords
- Delirium, Primary Prevention, Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Universidad de ValparaisoUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 20 May 2011 (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.
Delirium is a complex neuropsychiatric syndrome with an acute onset and fluctuating course which is presented in 15 to 20% of patients admitted to general wards. It is a potentially life - threatening complication which can be prevented. It is the objective of this randomized controlled trial to evaluate whether a multicomponent environmental intervention could reduce the incidence of delirium in a general medical ward.
Detailed description
A total of 287 patients 65 years of age or older who had been admitted to a general medicine ward and who were at risk of delirium were studied. Eligible patients were randomized to a multicomponent environmental intervention or standard care. Both groups were well balanced in patients characteristics and followed during the full hospital stay by a group trained in the application of the confusion assessment method to detect incident delirium.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Placebo comparator | Other: Standard CareDelirium management defined by the attending physician. |
| Environmental Intervention | Experimental | Other: Environmental Intervention |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Above 65 years of age and one of the following:
- Age above 70 years.
- Alcoholism
- Cognitive deficit (Mini mental state examination <24 points)
- Metabolic disturbance (Hyponatremia, Hypernatremia, Hyperkalemia, Hypokalemia Hyperglycemia or Hypoglycemia)
Key exclusion criteria (5 listed)
- Delirium at admission.
- Admittance to a ward other than general internal medicine.
- Lack of family support.
- Informed consent refusal.
- Hospitalization in a room with more than two beds.
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 |
|---|---|---|
| Environmental InterventionThe environmental intervention consisted of daily reorientation, avoidance of sensorial deprivation, longer visiting hours, the availability of a clock, a calendar and the presence of familiar objects in the room. | Other | Environmental Intervention |
| Standard CareDelirium management by the attending physician's preferences. | Other | Standard Care |
Primary outcome
Incidence of Delirium
Time frame: Daily during the entire hospital stay (Average: 10 days, Maximum: 42 days)
New episodes of delirium during the hospital stay
1 secondary outcome
Incidence of Falls
Time frame: Daily during the entire hospital stay (Average: 10 days, Maximum: 42 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 29 Jan 2019.
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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.
Felipe T Martinez, MD principal investigator
Universidad de Valparaiso
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Environmental Intervention in people with Delirium and Falls, run by Universidad de Valparaiso 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 5 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 29 Jan 2019. 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?
Incidence of Delirium (time frame: Daily during the entire hospital stay (Average: 10 days, Maximum: 42 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 29 Jan 2019.