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Digital Rehabilitation Environment Augmenting Medical System (DREAMS)

Primary Purpose

Delirium

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Technology based guided meditation and relaxation
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delirium focused on measuring Delirium Prevention, Virtual Reality, VR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients ≥ 18 years admitted to University of Florida (UF) Health Shands Hospital who do not have a positive Confusion Assessment Method (CAM) score, including ICU patients.

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

Sites / Locations

  • UF HealthRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mediation and Relaxation Intervention

Arm Description

Patients will undergo a technology based guided meditation and relaxation exercise through use of an application on a tablet or virtual reality headset.

Outcomes

Primary Outcome Measures

Assessment of anxiety measured by Hospital Anxiety and Depression Scale (HADS) questionnaire
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)
Blood Pressure -Systolic
Alterations to vital signs allow for Non-Verbal Pain assessments
Heart Rate
Alterations to vital signs allow for Non-Verbal Pain assessments

Secondary Outcome Measures

Respiratory Rate
Alterations to vital signs allow for Non-Verbal Pain assessments
Patient pain perception
Defense and Veterans Pain Rating Scale (DVPRS) Likert Scale 0 - 10, with 10 = severe pain (as bad as it could be. nothing else matters)
Amount of sedatives requested by subjects
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.
Amount of sedatives subjects receive
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.
Subject's quality of sleep
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.
DREAMS usability and acceptability questionnaire
A qualitative assessment of the usability and efficacy of the system Likert Scale 1-5, with 5 = strongly disagree.

Full Information

First Posted
December 20, 2017
Last Updated
August 9, 2023
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT03385993
Brief Title
Digital Rehabilitation Environment Augmenting Medical System
Acronym
DREAMS
Official Title
Digital Rehabilitation Environment Augmenting Medical System
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 16, 2018 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium
Keywords
Delirium Prevention, Virtual Reality, VR

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mediation and Relaxation Intervention
Arm Type
Experimental
Arm Description
Patients will undergo a technology based guided meditation and relaxation exercise through use of an application on a tablet or virtual reality headset.
Intervention Type
Device
Intervention Name(s)
Technology based guided meditation and relaxation
Intervention Description
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 Measure Information:
Title
Assessment of anxiety measured by Hospital Anxiety and Depression Scale (HADS) questionnaire
Description
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)
Time Frame
Immediately before and after each intervention Up to 7 days
Title
Blood Pressure -Systolic
Description
Alterations to vital signs allow for Non-Verbal Pain assessments
Time Frame
Immediately before and after each intervention up to 7 days
Title
Heart Rate
Description
Alterations to vital signs allow for Non-Verbal Pain assessments
Time Frame
Immediately before and after each intervention up to 7 days
Secondary Outcome Measure Information:
Title
Respiratory Rate
Description
Alterations to vital signs allow for Non-Verbal Pain assessments
Time Frame
Entire ICU stay up to 7 days
Title
Patient pain perception
Description
Defense and Veterans Pain Rating Scale (DVPRS) Likert Scale 0 - 10, with 10 = severe pain (as bad as it could be. nothing else matters)
Time Frame
Immediately before and after each intervention up to 7 days
Title
Amount of sedatives requested by subjects
Description
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.
Time Frame
Entire ICU stay up to 7 days
Title
Amount of sedatives subjects receive
Description
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.
Time Frame
Entire ICU stay up to 7 days
Title
Subject's quality of sleep
Description
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.
Time Frame
Daily up to 14 days
Title
DREAMS usability and acceptability questionnaire
Description
A qualitative assessment of the usability and efficacy of the system Likert Scale 1-5, with 5 = strongly disagree.
Time Frame
After each intervention up to 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients ≥ 18 years admitted to University of Florida (UF) Health Shands Hospital who do not have a positive Confusion Assessment Method (CAM) score, including ICU patients. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Davidson, BS
Phone
352-294-8723
Email
adavidson@ufl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Brooke Armfield, PhD
Phone
352-294-8723
Email
barmfield@ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Azra Bihorac, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
UF Health
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Davidson, BS
Phone
352-294-8723
Email
adavidson@ufl.edu
First Name & Middle Initial & Last Name & Degree
Brooke Armfield, PhD
Phone
352-294-8723
Email
barmfield@ufl.edu
First Name & Middle Initial & Last Name & Degree
Tezcan Ozrazgat Baslanti, PhD
First Name & Middle Initial & Last Name & Degree
Azra Bihorac, MD
First Name & Middle Initial & Last Name & Degree
Marko Suvajdzic, PhD
First Name & Middle Initial & Last Name & Degree
Parisa Rashidi, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Digital Rehabilitation Environment Augmenting Medical System

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