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Trial record 1 of 2 for:    11754849 [PUBMED-IDS]
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Prevention of Delirium After Bone Marrow Transplantation

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ClinicalTrials.gov Identifier: NCT01700816
Recruitment Status : Terminated (Low incidence of delirium.)
First Posted : October 4, 2012
Results First Posted : June 28, 2017
Last Update Posted : June 28, 2017
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
Carlos Fernandez-Robles, Massachusetts General Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Delirium
Interventions: Device: Bright light therapy
Device: Sham light

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Bright Light Therapy

2500 Lux gaze directed every morning from 8 am until 8:30 am

Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am.

Sham Light

<1000 Lux gaze directed every morning from 8 am until 8:30 am

Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.


Participant Flow:   Overall Study
    Bright Light Therapy   Sham Light
STARTED   21   19 
COMPLETED   21   19 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Bright Light Therapy

2500 Lux gaze directed every morning from 8 am until 8:30 am

Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am.

Sham Light

<1000 Lux gaze directed every morning from 8 am until 8:30 am

Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.

Total Total of all reporting groups

Baseline Measures
   Bright Light Therapy   Sham Light   Total 
Overall Participants Analyzed 
[Units: Participants]
 21   19   40 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 21   19   40 
   53.3  (12.84)   53.1  (14.15)   53.2  (13.49) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 21   19   40 
Female      3  14.3%      9  47.4%      12  30.0% 
Male      18  85.7%      10  52.6%      28  70.0% 
Race/Ethnicity, Customized [1] 
[Units: Participants]
Count of Participants
     
Non Hispanic White       
Participants Analyzed 
[Units: Participants]
 18   17   35 
Non Hispanic White   16   17   33 
Hispanic or Latino       
Participants Analyzed 
[Units: Participants]
 18   17   35 
Hispanic or Latino   1   0   1 
Asian       
Participants Analyzed 
[Units: Participants]
 18   17   35 
Asian   1   0   1 
[1] Information not provided during interviews by all participants
Marital Status [1] 
[Units: Participants]
Count of Participants
     
Married/Partnered       
Participants Analyzed 
[Units: Participants]
 17   17   34 
Married/Partnered   12   13   25 
Single/Divorced/Widowed       
Participants Analyzed 
[Units: Participants]
 17   17   34 
Single/Divorced/Widowed   5   4   9 
[1] Information not provided during interviews by all participants
Highest Education Level [1] 
[Units: Participants]
Count of Participants
     
11th grade or less       
Participants Analyzed 
[Units: Participants]
 17   15   32 
11th grade or less   1   0   1 
High School degree/GED       
Participants Analyzed 
[Units: Participants]
 21   19   40 
High School degree/GED   2   6   8 
Some College       
Participants Analyzed 
[Units: Participants]
 21   19   40 
Some College   2   2   4 
Completed College       
Participants Analyzed 
[Units: Participants]
 21   19   40 
Completed College   12   7   19 
[1] Information not provided during interviews by all participants


  Outcome Measures

1.  Primary:   Number of Participants Who Developed Delirium Based on Meeting Criteria on the Delirium Rating Scale and/or Memorial Delirium Assessment Scale   [ Time Frame: From hospital admission until the date of first documented delirium, assessed up to 28 days post-transplant ]

2.  Secondary:   Severity of Delirium Episodes: Memorial Delirium Assessment Scale (MDAS)   [ Time Frame: From first documented episode of delirium until discharge from the hospital, assessed up to 28 days post-transplant ]

3.  Secondary:   Average Dose of Antipsychotic Medications Required to Manage Delirium   [ Time Frame: From admission to hospital to discharge, an expected average of 28 days post-transplant ]

4.  Secondary:   Hospital Length of Stay   [ Time Frame: From admission to hospital to discharge, an expected average of 28 days post-transplant ]

5.  Secondary:   Sodium (Na), Potassium (K), Chloride (Cl), and Carbon Dioxide (CO2)   [ Time Frame: From admission to hospital to discharge, an expected average of 28 days post-transplant ]

6.  Secondary:   Serum Creatinine and Blood Urea Nitrogen (BUN)   [ Time Frame: From admission to hospital to discharge, an expected average of 28 days post-transplant ]

7.  Secondary:   Red Blood Cells (RBC)   [ Time Frame: From admission to hospital to discharge, an expected average of 28 days post-transplant ]

8.  Secondary:   White Blood Cells (WBC)   [ Time Frame: From admission to hospital to discharge, an expected average of 28 days post-transplant ]

9.  Secondary:   Hemoglobin (HGB)   [ Time Frame: From admission to hospital to discharge, an expected average of 28 days post-transplant ]

10.  Secondary:   Hematocrit (HCT)   [ Time Frame: From admission to hospital to discharge, an expected average of 28 days post-transplant ]

11.  Secondary:   Platelet Count   [ Time Frame: From admission to hospital to discharge, an expected average of 28 days post-transplant ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Carlos Fernandez Robles MD
Organization: Massachusetts General Hospital
phone: 6176432410
e-mail: cfernandez-robles@mgh.harvard.edu


Publications:
Reitan RM. Validity of the Trail Making test as an indicator of organic brain damage. Perceptual and Motor Skills 8: 271-276, 1958.
Derogatis LR, Savitz, KL. The SCL-90-R and the Brief Symptom Inventory (BSI) in Primary Care In: M.E.Maruish, ed. Handbook of psychological assessment in primary care settings 236: 297,334, 2000. Mahwah, NJ: Lawrence Erlbaum Associates.


Responsible Party: Carlos Fernandez-Robles, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01700816     History of Changes
Other Study ID Numbers: 2010P002801
First Submitted: October 1, 2012
First Posted: October 4, 2012
Results First Submitted: October 27, 2016
Results First Posted: June 28, 2017
Last Update Posted: June 28, 2017