Neurocognitive DisordersNCT04081090
Clinical Translational Science Institute (CTSI) Brain HQ Modules vs. Active Controls for Elderly Survivors of ICU
A study testing Brain HQ Cognitive Modules in people with Neurocognitive Disorders, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The purpose of this project is to test whether an online cognitive rehabilitation program or online thinking exercises helps improve memory and thinking in elderly patients who survive a severe infection. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Neurocognitive Disorders
- What is being tested?
- Brain HQ Cognitive Modules
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2019to 26 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Admitted to the Intensive Care Unit (ICU) at Froedtert Memorial Lutheran Hospital (FMLH)
- Diagnosis of Sepsis
- Age 65 years or older
- Required mechanical ventilation or vasopressor therapy while in the ICU
- Had delirium while in the ICU
Who cannot join
- Non-English Speaking
- Severe Dementia that would interfere with the ability to participate in the study activities
- Prior or current structural neurological injury that would confound study results
- Inability to communicate for any reason
- Current chemotherapy or radiation treatment
- Recent history of substance abuse
Show all 9Show fewer
- Life expectancy < 6 months
- Planned discharge to long term acute care facility or nursing home
- Lack reliable access to the internet either through a computer or smart device
Trial locations and contacts
1 site in 1 country.
United States1 site
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, 53226
About this study
Official title: Structured Cognitive Therapy to Improve Neurocognitive Dysfunction in Older Intensive Care Unit Sepsis Survivors
The purpose of this project is to test whether an online cognitive rehabilitation program or online thinking exercises helps improve memory and thinking in elderly patients who survive a severe infection.
Read the detailed description
Currently, over 50% of patients are estimated to develop an Alzheimer's like disease following their hospitalization. This means they might have trouble remembering simple things or doing simple tasks. This can make returning to normal life difficult. This project will test whether online thinking exercises can help speed up patient's recovery.
- Conditions
- Neurocognitive Disorders
- Being tested
- Brain HQ Cognitive Modules
- Medical subject headings
- Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain HQ Cognitive ModulesBehavioural
Online personalized cognitive therapy modules to address and improve neuroplasticity.
| Study group | Role | What they receive |
|---|---|---|
| Brain HQ adaptive Cognitive Therapy Modules | Experimental | Brain HQ licensed modules that adapt to each individuals unique strengths and weaknesses to address deficits and improve neuroplasticity. Receives: Behavioral: Brain HQ Cognitive Modules |
| Brain HQ Active Control Modules | Active comparator | Participants in this arm will complete puzzles such as crossword puzzles, Sudoku, etc. Receives: Behavioral: Brain HQ Cognitive Modules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tailored Online Cognitive Rehabilitation
Older survivors of sepsis will demonstrate > 80% adherence to a tailored cognitive rehabilitation program
Measured: 3 months
Adherence to Online Intervention Modules
In recruited survivors of sepsis investigator will measure adherence to a facilitated structured neurocognitive rehabilitation program (administered as one-hour sessions, three days per week for 3 months) via a computer or smart device/phone.
Measured: 3 months
Secondary outcomes (3)
Improvement in Neurocognitive Function part 1
A structured cognitive rehabilitation program will significantly improve neurocognitive function in older survivors of sepsis as measured by Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) 40 - 160 scale measuring Immediate Memory, Visuospatial/Constructional, Language, Attention and Delayed Memory , Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test.
Measured: 6 months
Improvement in Neurocognitive Function part 2
A structured cognitive rehabilitation program will significantly improve neurocognitive function in older survivors of sepsis as measured by Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test and Symbol-Digit Modality Test measuring the duration it takes to complete the test.
Measured: 6 months
Measure Differences in Cognitive Performance
Investigators will measure differences in cognitive performance at 3 and 6 months using the above mentioned tests in participants with active neurocognitive rehabilitation intervention as compared to controls. Consistent with the National Academy of Medicine recommendations the control group will receive an active intervention. This will include mind stimulating games such as Brain HQ crossword puzzles and Sudoku modules measuring the ability to complete and duration.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start15 Jan 2019
- Primary completion1 Mar 2020
- Study completion26 Aug 2020
Why it stopped: Delay due to COVID. Lost funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (49)Papers the sponsor has linked to this study.
- Other trials for Neurocognitive DisordersStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rahul Nanchal, Medical College of Wisconsin
- Investigators
- Rahul Nanchal, MD, MS, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081090
- Sponsor's protocol ID
- 32542
- Status last verified
- May 2021
- First submitted
- 30 Apr 2019
- Last updated
- 20 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual data collected as part of this project.
Publications
Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.
PubMed 15082703Pandharipande P, Cotton BA, Shintani A, Thompson J, Pun BT, Morris JA Jr, Dittus R, Ely EW. Prevalence and risk factors for development of delirium in surgical and trauma intensive care unit patients. J Trauma. 2008 Jul;65(1):34-41. doi: 10.1097/TA.0b013e31814b2c4d.
PubMed 18580517McPherson JA, Wagner CE, Boehm LM, Hall JD, Johnson DC, Miller LR, Burns KM, Thompson JL, Shintani AK, Ely EW, Pandharipande PP. Delirium in the cardiovascular ICU: exploring modifiable risk factors. Crit Care Med. 2013 Feb;41(2):405-13. doi: 10.1097/CCM.0b013e31826ab49b.
PubMed 23263581McNicoll L, Pisani MA, Zhang Y, Ely EW, Siegel MD, Inouye SK. Delirium in the intensive care unit: occurrence and clinical course in older patients. J Am Geriatr Soc. 2003 May;51(5):591-8. doi: 10.1034/j.1600-0579.2003.00201.x.
PubMed 12752832Pisani MA, Murphy TE, Van Ness PH, Araujo KL, Inouye SK. Characteristics associated with delirium in older patients in a medical intensive care unit. Arch Intern Med. 2007 Aug 13-27;167(15):1629-34. doi: 10.1001/archinte.167.15.1629.
PubMed 17698685Tsuruta R, Oda Y, Shintani A, Nunomiya S, Hashimoto S, Nakagawa T, Oida Y, Miyazaki D, Yabe S; Japanese Epidemiology of Delirium in ICUs (JEDI) Study Investigators. Delirium and coma evaluated in mechanically ventilated patients in the intensive care unit in Japan: a multi-institutional prospective observational study. J Crit Care. 2014 Jun;29(3):472.e1-5. doi: 10.1016/j.jcrc.2014.01.021. Epub 2014 Feb 3.
PubMed 24602999Lat I, McMillian W, Taylor S, Janzen JM, Papadopoulos S, Korth L, Ehtisham A, Nold J, Agarwal S, Azocar R, Burke P. The impact of delirium on clinical outcomes in mechanically ventilated surgical and trauma patients. Crit Care Med. 2009 Jun;37(6):1898-905. doi: 10.1097/CCM.0b013e31819ffe38.
PubMed 19384221Hsieh SJ, Soto GJ, Hope AA, Ponea A, Gong MN. The association between acute respiratory distress syndrome, delirium, and in-hospital mortality in intensive care unit patients. Am J Respir Crit Care Med. 2015 Jan 1;191(1):71-8. doi: 10.1164/rccm.201409-1690OC.
PubMed 25393331Milbrandt EB, Deppen S, Harrison PL, Shintani AK, Speroff T, Stiles RA, Truman B, Bernard GR, Dittus RS, Ely EW. Costs associated with delirium in mechanically ventilated patients. Crit Care Med. 2004 Apr;32(4):955-62. doi: 10.1097/01.ccm.0000119429.16055.92.
PubMed 15071384Almeida IC, Soares M, Bozza FA, Shinotsuka CR, Bujokas R, Souza-Dantas VC, Ely EW, Salluh JI. The impact of acute brain dysfunction in the outcomes of mechanically ventilated cancer patients. PLoS One. 2014 Jan 22;9(1):e85332. doi: 10.1371/journal.pone.0085332. eCollection 2014.
PubMed 24465538Gunther ML, Morandi A, Krauskopf E, Pandharipande P, Girard TD, Jackson JC, Thompson J, Shintani AK, Geevarghese S, Miller RR 3rd, Canonico A, Merkle K, Cannistraci CJ, Rogers BP, Gatenby JC, Heckers S, Gore JC, Hopkins RO, Ely EW; VISIONS Investigation, VISualizing Icu SurvivOrs Neuroradiological Sequelae. The association between brain volumes, delirium duration, and cognitive outcomes in intensive care unit survivors: the VISIONS cohort magnetic resonance imaging study*. Crit Care Med. 2012 Jul;40(7):2022-32. doi: 10.1097/CCM.0b013e318250acc0.
PubMed 22710202Girard TD, Jackson JC, Pandharipande PP, Pun BT, Thompson JL, Shintani AK, Gordon SM, Canonico AE, Dittus RS, Bernard GR, Ely EW. Delirium as a predictor of long-term cognitive impairment in survivors of critical illness. Crit Care Med. 2010 Jul;38(7):1513-20. doi: 10.1097/CCM.0b013e3181e47be1.
PubMed 20473145Girard TD, Thompson JL, Pandharipande PP, Brummel NE, Jackson JC, Patel MB, Hughes CG, Chandrasekhar R, Pun BT, Boehm LM, Elstad MR, Goodman RB, Bernard GR, Dittus RS, Ely EW. Clinical phenotypes of delirium during critical illness and severity of subsequent long-term cognitive impairment: a prospective cohort study. Lancet Respir Med. 2018 Mar;6(3):213-222. doi: 10.1016/S2213-2600(18)30062-6.
PubMed 29508705Wolters AE, van Dijk D, Pasma W, Cremer OL, Looije MF, de Lange DW, Veldhuijzen DS, Slooter AJ. Long-term outcome of delirium during intensive care unit stay in survivors of critical illness: a prospective cohort study. Crit Care. 2014 Jun 18;18(3):R125. doi: 10.1186/cc13929.
PubMed 24942154van den Boogaard M, Schoonhoven L, Evers AW, van der Hoeven JG, van Achterberg T, Pickkers P. Delirium in critically ill patients: impact on long-term health-related quality of life and cognitive functioning. Crit Care Med. 2012 Jan;40(1):112-8. doi: 10.1097/CCM.0b013e31822e9fc9.
PubMed 21926597
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structured Cognitive Therapy to Improve Neurocognitive Dysfunction in Older Intensive Care Unit Sepsis Survivors
- ClinicalTrials.gov ID
- NCT04081090
- Acronym / sponsor ID
- 32542
- Conditions
- Neurocognitive Disorders
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Delay due to COVID. Lost funding.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 26 Aug 2020 (actual)
- First posted
- 9 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this project is to test whether an online cognitive rehabilitation program or online thinking exercises helps improve memory and thinking in elderly patients who survive a severe infection.
Detailed description
Currently, over 50% of patients are estimated to develop an Alzheimer's like disease following their hospitalization. This means they might have trouble remembering simple things or doing simple tasks. This can make returning to normal life difficult. This project will test whether online thinking exercises can help speed up patient's recovery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brain HQ adaptive Cognitive Therapy Modules | Experimental | Behavioral: Brain HQ Cognitive ModulesBrain HQ licensed modules that adapt to each individuals unique strengths and weaknesses to address deficits and improve neuroplasticity. |
| Brain HQ Active Control Modules | Active comparator | Behavioral: Brain HQ Cognitive ModulesParticipants in this arm will complete puzzles such as crossword puzzles, Sudoku, etc. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Admitted to the Intensive Care Unit (ICU) at Froedtert Memorial Lutheran Hospital (FMLH)
- Diagnosis of Sepsis
- Age 65 years or older
- Required mechanical ventilation or vasopressor therapy while in the ICU
- Had delirium while in the ICU
Key exclusion criteria (9 listed)
- Non-English Speaking
- Severe Dementia that would interfere with the ability to participate in the study activities
- Prior or current structural neurological injury that would confound study results
- Inability to communicate for any reason
- Current chemotherapy or radiation treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain HQ Cognitive ModulesOnline personalized cognitive therapy modules to address and improve neuroplasticity. | Behavioural | Brain HQ Active Control Modules, Brain HQ adaptive Cognitive Therapy Modules |
Primary outcome
Tailored Online Cognitive Rehabilitation
Time frame: 3 months
Older survivors of sepsis will demonstrate > 80% adherence to a tailored cognitive rehabilitation program
Adherence to Online Intervention Modules
Time frame: 3 months
In recruited survivors of sepsis investigator will measure adherence to a facilitated structured neurocognitive rehabilitation program (administered as one-hour sessions, three days per week for 3 months) via a computer or smart device/phone.
3 secondary outcomes
Improvement in Neurocognitive Function part 1
Time frame: 6 months
Improvement in Neurocognitive Function part 2
Time frame: 6 months
Measure Differences in Cognitive Performance
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Delay due to COVID. Lost funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2021.
- Background: PubMed 15082703Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.
- Background: PubMed 18580517Pandharipande P, Cotton BA, Shintani A, Thompson J, Pun BT, Morris JA Jr, Dittus R, Ely EW. Prevalence and risk factors for development of delirium in surgical and trauma intensive care unit patients. J Trauma. 2008 Jul;65(1):34-41. doi: 10.1097/TA.0b013e31814b2c4d.
- Background: PubMed 23263581McPherson JA, Wagner CE, Boehm LM, Hall JD, Johnson DC, Miller LR, Burns KM, Thompson JL, Shintani AK, Ely EW, Pandharipande PP. Delirium in the cardiovascular ICU: exploring modifiable risk factors. Crit Care Med. 2013 Feb;41(2):405-13. doi: 10.1097/CCM.0b013e31826ab49b.
- Background: PubMed 12752832McNicoll L, Pisani MA, Zhang Y, Ely EW, Siegel MD, Inouye SK. Delirium in the intensive care unit: occurrence and clinical course in older patients. J Am Geriatr Soc. 2003 May;51(5):591-8. doi: 10.1034/j.1600-0579.2003.00201.x.
- Background: PubMed 17698685Pisani MA, Murphy TE, Van Ness PH, Araujo KL, Inouye SK. Characteristics associated with delirium in older patients in a medical intensive care unit. Arch Intern Med. 2007 Aug 13-27;167(15):1629-34. doi: 10.1001/archinte.167.15.1629.
- Background: PubMed 24602999Tsuruta R, Oda Y, Shintani A, Nunomiya S, Hashimoto S, Nakagawa T, Oida Y, Miyazaki D, Yabe S; Japanese Epidemiology of Delirium in ICUs (JEDI) Study Investigators. Delirium and coma evaluated in mechanically ventilated patients in the intensive care unit in Japan: a multi-institutional prospective observational study. J Crit Care. 2014 Jun;29(3):472.e1-5. doi: 10.1016/j.jcrc.2014.01.021. Epub 2014 Feb 3.
- Background: PubMed 19384221Lat I, McMillian W, Taylor S, Janzen JM, Papadopoulos S, Korth L, Ehtisham A, Nold J, Agarwal S, Azocar R, Burke P. The impact of delirium on clinical outcomes in mechanically ventilated surgical and trauma patients. Crit Care Med. 2009 Jun;37(6):1898-905. doi: 10.1097/CCM.0b013e31819ffe38.
- Background: PubMed 25393331Hsieh SJ, Soto GJ, Hope AA, Ponea A, Gong MN. The association between acute respiratory distress syndrome, delirium, and in-hospital mortality in intensive care unit patients. Am J Respir Crit Care Med. 2015 Jan 1;191(1):71-8. doi: 10.1164/rccm.201409-1690OC.
- Background: PubMed 15071384Milbrandt EB, Deppen S, Harrison PL, Shintani AK, Speroff T, Stiles RA, Truman B, Bernard GR, Dittus RS, Ely EW. Costs associated with delirium in mechanically ventilated patients. Crit Care Med. 2004 Apr;32(4):955-62. doi: 10.1097/01.ccm.0000119429.16055.92.
- Background: PubMed 24465538Almeida IC, Soares M, Bozza FA, Shinotsuka CR, Bujokas R, Souza-Dantas VC, Ely EW, Salluh JI. The impact of acute brain dysfunction in the outcomes of mechanically ventilated cancer patients. PLoS One. 2014 Jan 22;9(1):e85332. doi: 10.1371/journal.pone.0085332. eCollection 2014.
- Background: PubMed 22710202Gunther ML, Morandi A, Krauskopf E, Pandharipande P, Girard TD, Jackson JC, Thompson J, Shintani AK, Geevarghese S, Miller RR 3rd, Canonico A, Merkle K, Cannistraci CJ, Rogers BP, Gatenby JC, Heckers S, Gore JC, Hopkins RO, Ely EW; VISIONS Investigation, VISualizing Icu SurvivOrs Neuroradiological Sequelae. The association between brain volumes, delirium duration, and cognitive outcomes in intensive care unit survivors: the VISIONS cohort magnetic resonance imaging study*. Crit Care Med. 2012 Jul;40(7):2022-32. doi: 10.1097/CCM.0b013e318250acc0.
- Background: PubMed 20473145Girard TD, Jackson JC, Pandharipande PP, Pun BT, Thompson JL, Shintani AK, Gordon SM, Canonico AE, Dittus RS, Bernard GR, Ely EW. Delirium as a predictor of long-term cognitive impairment in survivors of critical illness. Crit Care Med. 2010 Jul;38(7):1513-20. doi: 10.1097/CCM.0b013e3181e47be1.
- Individual participant dataSharing planned: No. There is no plan to share individual data collected as part of this project.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rahul Nanchal, MD, MS principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain HQ Cognitive Modules in people with Neurocognitive Disorders, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Delay due to COVID. Lost funding.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tailored Online Cognitive Rehabilitation (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04081090, which also lists 49 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2021.