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Modified Environment for Agitation in Patients With TBI (ABS)

Primary Purpose

Traumatic Brain Injury (TBI), Agitated Behaviour

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Multifactorial circadian concept

About this trial

This is an interventional supportive care trial for Traumatic Brain Injury (TBI)

Eligibility Criteria

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

Inclusion Criteria:

Patients with moderate and severe Traumatic Brain Injury (TBI)
Diagnosed with Glasgow Coma Score (GCS) lower than 13-

Exclusion Criteria:

Patients with psychiatric diagnose and not speaking danish -

Sites / Locations

Leanne Langhorn

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Intervention: Circadian lighting, systematic information, music, foreclosure of the individual patient

Outcomes

Primary Outcome Measures

Agitation on Agitated Behaviour Scale (ABS)

Functional abilities on the Early Functional Abilities Scale (EFA)

Functional abilities on the Glasgow Outcome Extend Scale

Secondary Outcome Measures

Orientation and duration of post-traumatic amnesia on the Galveston Orientation and Amnesia Scale (GOAT)

Full Information

NCT ID

NCT02524067

First Posted

July 8, 2015

Last Updated

May 4, 2018

Sponsor

University of Aarhus

Collaborators

Aarhus University Hospital, Regionshospitalet Hammel Neurocenter, Rigshospitalet, Denmark, Glostrup University Hospital, Copenhagen

1. Study Identification

Unique Protocol Identification Number

NCT02524067

Brief Title

Modified Environment for Agitation in Patients With TBI

Acronym

ABS

Official Title

Modified Environment for Agitation in Patients With Traumatic Brain Injury: a Controlled Multicenter

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

September 2015 (undefined)

Primary Completion Date

May 2018 (Actual)

Study Completion Date

May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Aarhus

Collaborators

Aarhus University Hospital, Regionshospitalet Hammel Neurocenter, Rigshospitalet, Denmark, Glostrup University Hospital, Copenhagen

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study examines the effect of an intervention consisting of dynamic circadian light and sound therapy, as well as systematic information on sleep pattern, agitated behavior and functioning level.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Traumatic Brain Injury (TBI), Agitated Behaviour

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Intervention: Circadian lighting, systematic information, music, foreclosure of the individual patient

Intervention Type

Behavioral

Intervention Name(s)

Multifactorial circadian concept

Intervention Description

Circadian light, systematic information, music, individual foreclosure

Primary Outcome Measure Information:

Title

Agitation on Agitated Behaviour Scale (ABS)

Time Frame

One year

Title

Functional abilities on the Early Functional Abilities Scale (EFA)

Time Frame

One year

Title

Functional abilities on the Glasgow Outcome Extend Scale

Time Frame

12 month after admission

Secondary Outcome Measure Information:

Title

Orientation and duration of post-traumatic amnesia on the Galveston Orientation and Amnesia Scale (GOAT)

Time Frame

One year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with moderate and severe Traumatic Brain Injury (TBI) Diagnosed with Glasgow Coma Score (GCS) lower than 13- Exclusion Criteria: Patients with psychiatric diagnose and not speaking danish -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jens Christian H Sorensen, Professor

Organizational Affiliation

Aarhus University Hoapital

Official's Role

Study Chair

Facility Information:

Facility Name

Leanne Langhorn

City

Aarhus

State/Province

Region Midt

ZIP/Postal Code

8000

Country

Denmark

12. IPD Sharing Statement

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Modified Environment for Agitation in Patients With TBI

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