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Digital Rehabilitation Environment Augmenting Medical System (DREAMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03385993
Recruitment Status : Recruiting
First Posted : December 29, 2017
Last Update Posted : January 6, 2020
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief Summary:
D.R.E.A.M.S. will assess an immersive digital reality-augmenting system in reducing the occurrence of cognitive, behavioral, and emotional consequences of critical illness and environmental exposures that are risk factors for the development of delirium.

Condition or disease Intervention/treatment Phase
Delirium Device: Technology based guided meditation and relaxation Not Applicable

Detailed Description:
The purpose of Digital Rehabilitation Environment Augmenting Medical System (D.R.E.A.M.S.) is to research the feasibility and clinical potential of an immersive digital reality-augmenting system in reducing the occurrence of cognitive, behavioral, and emotional consequences of critical illness (e.g. pain, anxiety and insomnia) and environmental exposures (noise & light) that are risk factors for the development of delirium, a common and devastating complication in the intensive care unit (ICU).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Digital Rehabilitation Environment Augmenting Medical System
Actual Study Start Date : January 16, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mediation and Relaxation Intervention
Patients will undergo a technology based guided meditation and relaxation exercise through use of an application on a tablet or virtual reality headset.
Device: Technology based guided meditation and relaxation
Subjects will be guided through a mediation and relaxation exercise on a tablet or virtual reality headset for up to an hour each day.




Primary Outcome Measures :
  1. Assessment of anxiety measured by Hospital Anxiety and Depression Scale (HADS) questionnaire [ Time Frame: Immediately before and after each intervention Up to 7 days ]
    The assessment is used to gauge the subject's level of anxiety and depression 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)

  2. Blood Pressure -Systolic [ Time Frame: Immediately before and after each intervention up to 7 days ]
    Alterations to vital signs allow for Non-Verbal Pain assessments

  3. Heart Rate [ Time Frame: Immediately before and after each intervention up to 7 days ]
    Alterations to vital signs allow for Non-Verbal Pain assessments


Secondary Outcome Measures :
  1. Respiratory Rate [ Time Frame: Entire ICU stay up to 7 days ]
    Alterations to vital signs allow for Non-Verbal Pain assessments

  2. Patient pain perception [ Time Frame: Immediately before and after each intervention up to 7 days ]
    Defense and Veterans Pain Rating Scale (DVPRS) Likert Scale 0 - 10, with 10 = severe pain (as bad as it could be. nothing else matters)

  3. Amount of sedatives requested by subjects [ Time Frame: Entire ICU stay up to 7 days ]
    Richmond Agitation-Sedation Scale (RASS)- Patients with a RASS of -3 or less should have their sedation decreased or modified in order to achieve a RASS of -2 to 0. Patients with a RASS of 2 to 4 are not sedated enough and should be assessed for pain, anxiety, or delirium. The underlying etiology of the agitation should be investigated and appropriately treated to achieve a RASS of -2 to 0.

  4. Amount of sedatives subjects receive [ Time Frame: Entire ICU stay up to 7 days ]
    Richmond Agitation-Sedation Scale (RASS)- Patients with a RASS of -3 or less should have their sedation decreased or modified in order to achieve a RASS of -2 to 0. Patients with a RASS of 2 to 4 are not sedated enough and should be assessed for pain, anxiety, or delirium. The underlying etiology of the agitation should be investigated and appropriately treated to achieve a RASS of -2 to 0.

  5. Subject's quality of sleep [ Time Frame: Daily up to 14 days ]
    Richards-Campbell Sleep Questionnaire (RCSQ) five-item, visual analogue scale was designed as an outcome measure for assessing the perception of sleep in critically ill patients. The scale evaluates perceptions of depth of sleep, sleep onset latency, number of awakenings, time spent awake, and overall sleep quality.

  6. DREAMS usability and acceptability questionnaire [ Time Frame: After each intervention up to 14 days ]
    A qualitative assessment of the usability and efficacy of the system Likert Scale 1-5, with 5 = strongly disagree.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All ICU patients ≥ 18 years admitted to the intensive care units (ICUs) of University of Florida (UF) Health Shands Hospital
  • who do not have a positive Confusion Assessment Method (CAM) score

Exclusion Criteria: The study team will exclude patients if:

  • Their anticipated ICU stay is less than one day
  • Patient is intubated and cannot communicate.
  • Age: < 18 years
  • Patient with recent (within 6 months) neuro-vascular event, intra-cranial surgery, and/or acute neurological condition as primary ICU admission reason
  • Baseline cognitive impairment (e.g., advanced dementia)
  • Patients who are unable to wear or use the DREAMS equipment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03385993


Contacts
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Contact: Sandhya A Chheda, JD 352-273-8820 sandhya.chheda@medicine.ufl.edu
Contact: Azra Bihorac, MD 352-273-8821 Azra.Bihorac@medicine.ufl.edu

Locations
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United States, Florida
UF Health Recruiting
Gainesville, Florida, United States, 32610
Contact: Sandhya A Chheda, JD    352-273-8820    sandhya.chheda@medicine.ufl.edu   
Contact: Azra Bihorac, MD    52-273-8821    Azra.Bihorac@medicine.ufl.edu   
Sub-Investigator: Tezcan Ozrazgat Baslanti, PhD         
Principal Investigator: Azra Bihorac, PhD         
Principal Investigator: Marko Suvajdzic, PhD         
Principal Investigator: Parisa Rashidi, PhD         
Sub-Investigator: Triton Ong, MA         
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Azra Bihorac, MD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03385993    
Other Study ID Numbers: IRB201703107
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: January 6, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by University of Florida:
Delirium Prevention
Virtual Reality
VR
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders