Trial Outcomes & Findings for Prevention of Delirium After Bone Marrow Transplantation (NCT NCT01700816)
NCT ID: NCT01700816
Last Updated: 2017-06-28
Results Overview
Monday, Wednesday, and Friday assessments will begin after beginning light therapy and include the Delirium Rating Scale-Revised-98 (DRS-98)and Memorial Delirium Assessment Scale (MDAS)
TERMINATED
NA
40 participants
From hospital admission until the date of first documented delirium, assessed up to 28 days post-transplant
2017-06-28
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
19
|
|
Overall Study
COMPLETED
|
21
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Information not provided during interviews by all participants
Baseline characteristics by cohort
| Measure |
Bright Light Therapy
n=21 Participants
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
n=19 Participants
\<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
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.3 years
STANDARD_DEVIATION 12.84 • n=21 Participants
|
53.1 years
STANDARD_DEVIATION 14.15 • n=19 Participants
|
53.2 years
STANDARD_DEVIATION 13.49 • n=40 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=21 Participants
|
9 Participants
n=19 Participants
|
12 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=21 Participants
|
10 Participants
n=19 Participants
|
28 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Non Hispanic White
|
16 Participants
n=18 Participants • Information not provided during interviews by all participants
|
17 Participants
n=17 Participants • Information not provided during interviews by all participants
|
33 Participants
n=35 Participants • Information not provided during interviews by all participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=18 Participants • Information not provided during interviews by all participants
|
0 Participants
n=17 Participants • Information not provided during interviews by all participants
|
1 Participants
n=35 Participants • Information not provided during interviews by all participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=18 Participants • Information not provided during interviews by all participants
|
0 Participants
n=17 Participants • Information not provided during interviews by all participants
|
1 Participants
n=35 Participants • Information not provided during interviews by all participants
|
|
Marital Status
Married/Partnered
|
12 Participants
n=17 Participants • Information not provided during interviews by all participants
|
13 Participants
n=17 Participants • Information not provided during interviews by all participants
|
25 Participants
n=34 Participants • Information not provided during interviews by all participants
|
|
Marital Status
Single/Divorced/Widowed
|
5 Participants
n=17 Participants • Information not provided during interviews by all participants
|
4 Participants
n=17 Participants • Information not provided during interviews by all participants
|
9 Participants
n=34 Participants • Information not provided during interviews by all participants
|
|
Highest Education Level
11th grade or less
|
1 Participants
n=17 Participants • Information not provided during interviews by all participants
|
0 Participants
n=15 Participants • Information not provided during interviews by all participants
|
1 Participants
n=32 Participants • Information not provided during interviews by all participants
|
|
Highest Education Level
High School degree/GED
|
2 Participants
n=21 Participants • Information not provided during interviews by all participants
|
6 Participants
n=19 Participants • Information not provided during interviews by all participants
|
8 Participants
n=40 Participants • Information not provided during interviews by all participants
|
|
Highest Education Level
Some College
|
2 Participants
n=21 Participants • Information not provided during interviews by all participants
|
2 Participants
n=19 Participants • Information not provided during interviews by all participants
|
4 Participants
n=40 Participants • Information not provided during interviews by all participants
|
|
Highest Education Level
Completed College
|
12 Participants
n=21 Participants • Information not provided during interviews by all participants
|
7 Participants
n=19 Participants • Information not provided during interviews by all participants
|
19 Participants
n=40 Participants • Information not provided during interviews by all participants
|
PRIMARY outcome
Timeframe: From hospital admission until the date of first documented delirium, assessed up to 28 days post-transplantPopulation: Only 20 bright light therapy and 18 sham light participants were analyzed because 2 participants (one from each arm) only had one assessment. Consequently, no change could be documented to analyze change of delirium scales. They did not drop out; they just completed their transplant before more data could be gathered.
Monday, Wednesday, and Friday assessments will begin after beginning light therapy and include the Delirium Rating Scale-Revised-98 (DRS-98)and Memorial Delirium Assessment Scale (MDAS)
Outcome measures
| Measure |
Bright Light Therapy
n=20 Participants
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
n=18 Participants
\<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.
|
|---|---|---|
|
Number of Participants Who Developed Delirium Based on Meeting Criteria on the Delirium Rating Scale and/or Memorial Delirium Assessment Scale
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first documented episode of delirium until discharge from the hospital, assessed up to 28 days post-transplantPopulation: Only one case of delirium developed, and only an MDAS score was collected for this participant.
Monday, Wednesday, and Friday assessments of the Memorial Delirium Assessment Scale (MDAS); Patients will receive assessments after beginning light therapy until day 28 post-transplant or discharge, whichever comes first. 10 item scale Items are rated on a four-point scale from 0 (none) to 3 (severe) depending on the level of impairment, rendering a maximum possible score of 30. A score of 13 has been recommended as a cut-off for establishing the diagnosis of delirium
Outcome measures
| Measure |
Bright Light Therapy
n=1 Participants
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.
|
|---|---|---|
|
Severity of Delirium Episodes: Memorial Delirium Assessment Scale (MDAS)
|
18 units on a scale
|
—
|
SECONDARY outcome
Timeframe: From admission to hospital to discharge, an expected average of 28 days post-transplantPopulation: Only one case of delirium developed, and we did not collect data on antipsychotic medication use for this one participant.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From admission to hospital to discharge, an expected average of 28 days post-transplantPopulation: One participant in the sham light arm was missing date of discharge, so only 18 hospital lengths of stay were able to be calculated in that arm.
Outcome measures
| Measure |
Bright Light Therapy
n=21 Participants
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
n=18 Participants
\<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.
|
|---|---|---|
|
Hospital Length of Stay
|
18 days
Interval 17.0 to 21.0
|
18.5 days
Interval 15.0 to 22.0
|
SECONDARY outcome
Timeframe: From admission to hospital to discharge, an expected average of 28 days post-transplantPopulation: 8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group
Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT (Hematopoietic Stem Cell Transplantation).
Outcome measures
| Measure |
Bright Light Therapy
n=13 Participants
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
n=12 Participants
\<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.
|
|---|---|---|
|
Sodium (Na), Potassium (K), Chloride (Cl), and Carbon Dioxide (CO2)
Sodium (Na)
|
139 mmol/L
Interval 137.0 to 139.0
|
138.0 mmol/L
Interval 136.0 to 140.5
|
|
Sodium (Na), Potassium (K), Chloride (Cl), and Carbon Dioxide (CO2)
Potassium (K)
|
3.6 mmol/L
Interval 3.5 to 3.8
|
3.80 mmol/L
Interval 3.45 to 4.3
|
|
Sodium (Na), Potassium (K), Chloride (Cl), and Carbon Dioxide (CO2)
Chloride (Cl)
|
105 mmol/L
Interval 103.0 to 105.0
|
103.0 mmol/L
Interval 102.0 to 106.5
|
|
Sodium (Na), Potassium (K), Chloride (Cl), and Carbon Dioxide (CO2)
Carbon Dioxide (CO2)
|
24.9 mmol/L
Interval 24.6 to 26.6
|
25.10 mmol/L
Interval 23.4 to 26.55
|
SECONDARY outcome
Timeframe: From admission to hospital to discharge, an expected average of 28 days post-transplantPopulation: 8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group
Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.
Outcome measures
| Measure |
Bright Light Therapy
n=13 Participants
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
n=12 Participants
\<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.
|
|---|---|---|
|
Serum Creatinine and Blood Urea Nitrogen (BUN)
Serum Creatinine
|
0.66 mg/dl
Interval 0.54 to 0.84
|
0.75 mg/dl
Interval 0.47 to 0.84
|
|
Serum Creatinine and Blood Urea Nitrogen (BUN)
Blood Urea Nitrogen (BUN)
|
9 mg/dl
Interval 6.0 to 12.0
|
8.5 mg/dl
Interval 4.5 to 10.5
|
SECONDARY outcome
Timeframe: From admission to hospital to discharge, an expected average of 28 days post-transplantPopulation: 8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group
Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.
Outcome measures
| Measure |
Bright Light Therapy
n=13 Participants
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
n=12 Participants
\<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.
|
|---|---|---|
|
Red Blood Cells (RBC)
|
3.21 M/uL
Interval 2.88 to 3.31
|
2.93 M/uL
Interval 2.8 to 3.16
|
SECONDARY outcome
Timeframe: From admission to hospital to discharge, an expected average of 28 days post-transplantPopulation: 8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group
Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.
Outcome measures
| Measure |
Bright Light Therapy
n=13 Participants
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
n=12 Participants
\<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.
|
|---|---|---|
|
White Blood Cells (WBC)
|
2.30 K/uL
Interval 2.1 to 4.0
|
4.75 K/uL
Interval 1.55 to 7.4
|
SECONDARY outcome
Timeframe: From admission to hospital to discharge, an expected average of 28 days post-transplantPopulation: 8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group
Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.
Outcome measures
| Measure |
Bright Light Therapy
n=13 Participants
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
n=12 Participants
\<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.
|
|---|---|---|
|
Hemoglobin (HGB)
|
9.70 g/dl
Interval 8.9 to 10.2
|
9.55 g/dl
Interval 8.85 to 9.9
|
SECONDARY outcome
Timeframe: From admission to hospital to discharge, an expected average of 28 days post-transplantPopulation: 8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group
Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.
Outcome measures
| Measure |
Bright Light Therapy
n=13 Participants
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
n=12 Participants
\<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.
|
|---|---|---|
|
Hematocrit (HCT)
|
28.20 volume percentage (vol%) of red blood ce
Interval 25.2 to 29.9
|
26.70 volume percentage (vol%) of red blood ce
Interval 25.7 to 28.65
|
SECONDARY outcome
Timeframe: From admission to hospital to discharge, an expected average of 28 days post-transplantPopulation: 8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group
Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.
Outcome measures
| Measure |
Bright Light Therapy
n=13 Participants
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
n=12 Participants
\<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.
|
|---|---|---|
|
Platelet Count
|
39 thousand cells/uL
Interval 33.0 to 94.0
|
33.5 thousand cells/uL
Interval 24.5 to 47.5
|
Adverse Events
Bright Light Therapy
Sham Light
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Carlos Fernandez Robles MD
Massachusetts General Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place