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Low incidence of delirium.
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| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
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The purpose of this study is to find out if using bright light sessions during bone marrow transplant can prevent people from developing confusion also known as delirium.
This is a pilot, double blind randomized study conducted in patients scheduled to undergo bone marrow transplant at the Massachusetts General Hospital. The goal of this study is to look at the usefulness of bright light therapy in the prevention of delirium in a population at high risk for developing this condition.
Delirium can develop in up to half of the people that undergo bone marrow transplant. Symptoms include changes in level of alertness, confusion, and temporary problems with memory and attention. In severe cases, it can be accompanied by agitation, paranoia(overly suspicious), and hallucinations(seeing or hearing things that are not really there).
Bright light uses no medication and is often used to treat seasonal affective depression and multiple sleep disorders. The light boxes are portable and are placed in front of individuals for about 30 minutes every day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bright light therapy | Experimental | 2500 Lux gaze directed every morning from 8 am until 8:30 am |
|
| Sham light | Placebo Comparator | <1000 Lux gaze directed every morning from 8 am until 8:30 am |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bright light therapy | Device | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Developed Delirium Based on Meeting Criteria on the Delirium Rating Scale and/or Memorial Delirium Assessment Scale | 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) | From hospital admission until the date of first documented delirium, assessed up to 28 days post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of Delirium Episodes: Memorial Delirium Assessment Scale (MDAS) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Fernandez-Robles, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17999893 | Background | Kirshner HS. Delirium: a focused review. Curr Neurol Neurosci Rep. 2007 Nov;7(6):479-82. doi: 10.1007/s11910-007-0074-7. | |
| 15882768 | Background | Minden SL, Carbone LA, Barsky A, Borus JF, Fife A, Fricchione GL, Orav EJ. Predictors and outcomes of delirium. Gen Hosp Psychiatry. 2005 May-Jun;27(3):209-14. doi: 10.1016/j.genhosppsych.2004.12.004. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Sham Light |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Developed Delirium Based on Meeting Criteria on the Delirium Rating Scale and/or Memorial Delirium Assessment Scale | 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) | 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. | Posted | Count of Participants | Participants | From hospital admission until the date of first documented delirium, assessed up to 28 days post-transplant |
|
28 days post-transplant or discharge, whichever comes first
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carlos Fernandez Robles MD | Massachusetts General Hospital | 6176432410 | cfernandez-robles@mgh.harvard.edu |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D014467 | Ultraviolet Therapy |
| ID | Term |
|---|---|
| D010789 | Phototherapy |
| D013812 | Therapeutics |
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|
| Sham light | Device | 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. |
|
|
| From first documented episode of delirium until discharge from the hospital, assessed up to 28 days post-transplant |
| Average Dose of Antipsychotic Medications Required to Manage Delirium | From admission to hospital to discharge, an expected average of 28 days post-transplant |
| Hospital Length of Stay | From admission to hospital to discharge, an expected average of 28 days post-transplant |
| Sodium (Na), Potassium (K), Chloride (Cl), and Carbon Dioxide (CO2) | 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). | From admission to hospital to discharge, an expected average of 28 days post-transplant |
| Serum Creatinine and Blood Urea Nitrogen (BUN) | Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT. | From admission to hospital to discharge, an expected average of 28 days post-transplant |
| Red Blood Cells (RBC) | Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT. | From admission to hospital to discharge, an expected average of 28 days post-transplant |
| White Blood Cells (WBC) | Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT. | From admission to hospital to discharge, an expected average of 28 days post-transplant |
| Hemoglobin (HGB) | Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT. | From admission to hospital to discharge, an expected average of 28 days post-transplant |
| Hematocrit (HCT) | Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT. | From admission to hospital to discharge, an expected average of 28 days post-transplant |
| Platelet Count | Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT. | From admission to hospital to discharge, an expected average of 28 days post-transplant |
| 10335730 | Background | Inouye SK, Schlesinger MJ, Lydon TJ. Delirium: a symptom of how hospital care is failing older persons and a window to improve quality of hospital care. Am J Med. 1999 May;106(5):565-73. doi: 10.1016/s0002-9343(99)00070-4. |
| 18593786 | Background | Fricchione GL, Nejad SH, Esses JA, Cummings TJ Jr, Querques J, Cassem NH, Murray GB. Postoperative delirium. Am J Psychiatry. 2008 Jul;165(7):803-12. doi: 10.1176/appi.ajp.2008.08020181. No abstract available. |
| 18693233 | Background | Hshieh TT, Fong TG, Marcantonio ER, Inouye SK. Cholinergic deficiency hypothesis in delirium: a synthesis of current evidence. J Gerontol A Biol Sci Med Sci. 2008 Jul;63(7):764-72. doi: 10.1093/gerona/63.7.764. |
| 16181163 | Background | Kalisvaart KJ, de Jonghe JF, Bogaards MJ, Vreeswijk R, Egberts TC, Burger BJ, Eikelenboom P, van Gool WA. Haloperidol prophylaxis for elderly hip-surgery patients at risk for delirium: a randomized placebo-controlled study. J Am Geriatr Soc. 2005 Oct;53(10):1658-66. doi: 10.1111/j.1532-5415.2005.53503.x. |
| 17933157 | Background | Prakanrattana U, Prapaitrakool S. Efficacy of risperidone for prevention of postoperative delirium in cardiac surgery. Anaesth Intensive Care. 2007 Oct;35(5):714-9. doi: 10.1177/0310057X0703500509. |
| 16319303 | Background | Liptzin B, Laki A, Garb JL, Fingeroth R, Krushell R. Donepezil in the prevention and treatment of post-surgical delirium. Am J Geriatr Psychiatry. 2005 Dec;13(12):1100-6. doi: 10.1176/appi.ajgp.13.12.1100. |
| 17006875 | Background | Sampson EL, Raven PR, Ndhlovu PN, Vallance A, Garlick N, Watts J, Blanchard MR, Bruce A, Blizard R, Ritchie CW. A randomized, double-blind, placebo-controlled trial of donepezil hydrochloride (Aricept) for reducing the incidence of postoperative delirium after elective total hip replacement. Int J Geriatr Psychiatry. 2007 Apr;22(4):343-9. doi: 10.1002/gps.1679. |
| 16914695 | Background | Leung JM, Sands LP, Rico M, Petersen KL, Rowbotham MC, Dahl JB, Ames C, Chou D, Weinstein P. Pilot clinical trial of gabapentin to decrease postoperative delirium in older patients. Neurology. 2006 Oct 10;67(7):1251-3. doi: 10.1212/01.wnl.0000233831.87781.a9. Epub 2006 Aug 16. |
| 19460856 | Background | Tabet N, Howard R. Non-pharmacological interventions in the prevention of delirium. Age Ageing. 2009 Jul;38(4):374-9. doi: 10.1093/ageing/afp039. Epub 2009 May 21. |
| 10053175 | Background | Inouye SK, Bogardus ST Jr, Charpentier PA, Leo-Summers L, Acampora D, Holford TR, Cooney LM Jr. A multicomponent intervention to prevent delirium in hospitalized older patients. N Engl J Med. 1999 Mar 4;340(9):669-76. doi: 10.1056/NEJM199903043400901. |
| 3625989 | Background | Lipowski ZJ. Delirium (acute confusional states). JAMA. 1987 Oct 2;258(13):1789-92. |
| 11754849 | Background | Shigeta H, Yasui A, Nimura Y, Machida N, Kageyama M, Miura M, Menjo M, Ikeda K. Postoperative delirium and melatonin levels in elderly patients. Am J Surg. 2001 Nov;182(5):449-54. doi: 10.1016/s0002-9610(01)00761-9. |
| 2915324 | Background | McIntyre IM, Norman TR, Burrows GD, Armstrong SM. Human melatonin suppression by light is intensity dependent. J Pineal Res. 1989;6(2):149-56. doi: 10.1111/j.1600-079x.1989.tb00412.x. |
| 2056432 | Background | Petterborg LJ, Kjellman BF, Thalen BE, Wetterberg L. Effect of a 15 minute light pulse on nocturnal serum melatonin levels in human volunteers. J Pineal Res. 1991 Jan;10(1):9-13. doi: 10.1111/j.1600-079x.1991.tb00003.x. |
| 19698553 | Background | Fortuyn HD, Schoemaker J. Treatment of delirium with phototherapy: a case report. Eur Psychiatry. 1997;12(7):367-8. doi: 10.1016/s0924-9338(97)80007-7. |
| 9380792 | Background | Schmitz M, Frey R, Pichler P, Ropke H, Anderer P, Saletu B, Rudas S. Sleep quality during alcohol withdrawal with bright light therapy. Prog Neuropsychopharmacol Biol Psychiatry. 1997 Aug;21(6):965-77. doi: 10.1016/s0278-5846(97)00092-4. |
| 17692522 | Background | Taguchi T, Yano M, Kido Y. Influence of bright light therapy on postoperative patients: a pilot study. Intensive Crit Care Nurs. 2007 Oct;23(5):289-97. doi: 10.1016/j.iccn.2007.04.004. Epub 2007 Aug 9. |
| 16920558 | Background | Beglinger LJ, Duff K, Van Der Heiden S, Parrott K, Langbehn D, Gingrich R. Incidence of delirium and associated mortality in hematopoietic stem cell transplantation patients. Biol Blood Marrow Transplant. 2006 Sep;12(9):928-35. doi: 10.1016/j.bbmt.2006.05.009. |
| 12404292 | Background | Fann JR, Roth-Roemer S, Burington BE, Katon WJ, Syrjala KL. Delirium in patients undergoing hematopoietic stem cell transplantation. Cancer. 2002 Nov 1;95(9):1971-81. doi: 10.1002/cncr.10889. |
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| Background | Reitan RM. Validity of the Trail Making test as an indicator of organic brain damage. Perceptual and Motor Skills 8: 271-276, 1958. |
| Background | 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. |
| 11449030 | Background | Trzepacz PT, Mittal D, Torres R, Kanary K, Norton J, Jimerson N. Validation of the Delirium Rating Scale-revised-98: comparison with the delirium rating scale and the cognitive test for delirium. J Neuropsychiatry Clin Neurosci. 2001 Spring;13(2):229-42. doi: 10.1176/jnp.13.2.229. |
| 9114631 | Background | Breitbart W, Rosenfeld B, Roth A, Smith MJ, Cohen K, Passik S. The Memorial Delirium Assessment Scale. J Pain Symptom Manage. 1997 Mar;13(3):128-37. doi: 10.1016/s0885-3924(96)00316-8. |
| 7434030 | Background | Lewy AJ, Wehr TA, Goodwin FK, Newsome DA, Markey SP. Light suppresses melatonin secretion in humans. Science. 1980 Dec 12;210(4475):1267-9. doi: 10.1126/science.7434030. |
<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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Information not provided during interviews by all participants | Count of Participants | Participants |
|
| Marital Status | Information not provided during interviews by all participants | Count of Participants | Participants |
|
| Highest Education Level | Information not provided during interviews by all participants | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| Secondary | Severity of Delirium Episodes: Memorial Delirium Assessment Scale (MDAS) | 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 | Only one case of delirium developed, and only an MDAS score was collected for this participant. | Posted | Number | units on a scale | From first documented episode of delirium until discharge from the hospital, assessed up to 28 days post-transplant |
|
|
|
| Secondary | Average Dose of Antipsychotic Medications Required to Manage Delirium | Only one case of delirium developed, and we did not collect data on antipsychotic medication use for this one participant. | Posted | From admission to hospital to discharge, an expected average of 28 days post-transplant |
|
|
| Secondary | Hospital Length of Stay | 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. | Posted | Median | Inter-Quartile Range | days | From admission to hospital to discharge, an expected average of 28 days post-transplant |
|
|
|
| Secondary | Sodium (Na), Potassium (K), Chloride (Cl), and Carbon Dioxide (CO2) | 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). | 8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group | Posted | Median | Inter-Quartile Range | mmol/L | From admission to hospital to discharge, an expected average of 28 days post-transplant |
|
|
|
| Secondary | Serum Creatinine and Blood Urea Nitrogen (BUN) | Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT. | 8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group | Posted | Median | Inter-Quartile Range | mg/dl | From admission to hospital to discharge, an expected average of 28 days post-transplant |
|
|
|
| Secondary | Red Blood Cells (RBC) | Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT. | 8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group | Posted | Median | Inter-Quartile Range | M/uL | From admission to hospital to discharge, an expected average of 28 days post-transplant |
|
|
|
| Secondary | White Blood Cells (WBC) | Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT. | 8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group | Posted | Median | Inter-Quartile Range | K/uL | From admission to hospital to discharge, an expected average of 28 days post-transplant |
|
|
|
| Secondary | Hemoglobin (HGB) | Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT. | 8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group | Posted | Median | Inter-Quartile Range | g/dl | From admission to hospital to discharge, an expected average of 28 days post-transplant |
|
|
|
| Secondary | Hematocrit (HCT) | Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT. | 8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group | Posted | Median | Inter-Quartile Range | volume percentage (vol%) of red blood ce | From admission to hospital to discharge, an expected average of 28 days post-transplant |
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|
| Secondary | Platelet Count | Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT. | 8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group | Posted | Median | Inter-Quartile Range | thousand cells/uL | From admission to hospital to discharge, an expected average of 28 days post-transplant |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | 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. | 0 | 19 | 0 | 19 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| Chloride (Cl) |
|
| Carbon Dioxide (CO2) |
|