DeliriumNCT05373017
Delirium and Neuropsychological Recovery Among Emergency General Surgery Survivors
A study testing DANE Recovery Program and Questionnaires in people with Delirium, run by University of Wisconsin, Madison at 6 sites in United States.
Trial summary
This study will evaluate the usefulness of the Urgent and Emergency Surgery (UES) Delirium Recovery Model. It is hypothesized that the cognitive, physical and psychological recovery of older UES delirium survivors will be improved through the use of the DANE Recovery Model. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Delirium
- What is being tested?
- DANE Recovery Program and Questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 528 participants
- Where
- 6 sitesUnited States
- Study dates
- 13 Feb 2023to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adult age 65 years and older
- Admitted to one of the participating hospitals
- Undergone an abdominal orthopedic, skin, or vascular surgery in an emergency or unplanned fashion
- English-speaking
- Able to provide consent or have a legally authorized representative to provide consent
- Access to a telephone or an internet connected computer or smart device
- Discharged to home or sub-acute rehabilitation
- At least one episode of delirium or subsyndromal delirium, i.e. screen positive on at least one out of the four items on the Confusion Assessment Method-ICU (CAM-ICU) in the period prior to discharge from acute care.
Who cannot join
- A self-reported diagnosis of cancer with short life expectancy
- A history of dementing illnesses and other neurodegenerative disease such as Alzheimer's disease (AD), Parkinson disease, or vascular dementia, or current prescription of anti-dementia medication, or ruled out by Functional Activities Questionnaire (FAQ) score defining dementia; a history of significant traumatic brain injury
- Acute or subacute neurologic deficit expected to prevent independent living after hospital discharge, e.g., a history of a significant traumatic brain injury
- Have any spinal cord injury with persistent neurologic deficit at the time of study enrollment
- Incarcerated or homeless at the time of study enrollment
- Acquired neurologic injury (stroke, traumatic brain injury, cerebral edema/swelling, anoxic brain injury, or any other acute/subacute severe neurologic deficit) as the admitting diagnosis or a new event during the course of hospitalization (confirmed by EMR)
- A history of bipolar disorder or schizophrenia (confirmed by EMR)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Indiana University
Indianapolis, Indiana, 47405
University of Wisconsin
Madison, Wisconsin, 53705
Meriter Hospital
Madison, Wisconsin, 53715
East Madison Hospital
Madison, Wisconsin, 53718
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
SwedishAmerican Hospital
Rockford, Illinois, 61104
About this study
Official title: Delirium and Neuropsychological Recovery Among Emergency General Surgery Survivors (DANE)
This study will evaluate the usefulness of the Urgent and Emergency Surgery (UES) Delirium Recovery Model. It is hypothesized that the cognitive, physical and psychological recovery of older UES delirium survivors will be improved through the use of the DANE Recovery Model. Participants can expect to be on the study for 18 months.
Read the detailed description
This is a multi-site, two-arm, single-blinded randomized controlled clinical trial to evaluate the efficacy of the DANE Recovery Model to improve the cognitive, physical and psychological recovery of older UES delirium survivors. At or near the time of discharge, enrolled participants will be randomized to receive the DANE Recovery Model or usual care. The hypothesis is that, after 18 months, older UES delirium survivors who are randomized to the DANE Recovery Model will experience more favorable cognitive, physical and psychological recovery in comparison to those randomized to usual care.
- Conditions
- Delirium
- Being tested
- DANE Recovery Program, Questionnaires
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DANE Recovery ProgramOther
Virtual visits with care coordinator to carry out an individualized recovery plan
QuestionnairesOther
Physical, cognitive, and psychological assessments
| Study group | Role | What they receive |
|---|---|---|
| DANE Recovery Model | Experimental | The delivery of the model will occur in five phases that correspond to the known stages of recovery after surgery. During the acute stage (0 - 1 month after surgery), participants will undergo the initial case review and two initial virtual visits, and the development of the recovery care plan. During the recovery (2 - 6 months after surgery) and maintenance (7-12 months after surgery) stages, the participants will undergo the interaction phase of the DANE Recovery Model. Receives: Other: DANE Recovery Program |
| Usual Care | Other | Participants will receive the usual rehabilitation and post-operative care. Receives: Other: DANE Recovery Program; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in overall cognitive recovery
Change in score on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) cognitive screening assessment. The measure consists of 12 subtests that contribute to a total score and Index scores across five domains: Immediate Memory, Visuospatial-Constructional, Language, Attention, and Delayed Memory. Index scores are converted to age-based standard scores (Mean = 100, Standard Deviation = 15)
Measured: Baseline, 6 months, 12 months, and 18 months
Secondary outcomes (4)
Short Physical Performance Battery (SPPB)
Change in overall physical recovery will be assessed using Short Physical Performance Battery (SPPB). SPPB is a group of measures that combines the results of the gait speed, chair stand and balance tests, and yields a performance score of 0-12; 0-4 poor, 5-7 intermediate, 8-12 good.
Measured: Baseline, 6 months, 12 months, and 18 months
Change in overall physical recovery
Change in overall physical recovery will be assessed using 36-Item Short Form Survey (SF-36). SF-36 scale has eight components (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health).
Measured: Baseline, 6 months, 12 months, and 18 months
Patient Health Questionnaire-9 (PHQ-9)
Change in overall psychological recovery will be assessed using Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a nine-item depression scale with a total score from 0 to 27, with higher scores indicating greater depression.
Measured: Baseline, 6 months, 12 months, and 18 months
General Anxiety Disorder-7 (GAD-7) .
Change in overall psychological recovery will be assessed using General Anxiety Disorder-7 (GAD-7) to determine the impact of the intervention on participant's mood and anxiety. The GAD-7 is a seven-item anxiety scale with a total score from 0 to 27, with higher scores indicating greater anxiety.
Measured: Baseline, 6 months, 12 months, and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start13 Feb 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 528 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Ben Zarzaur, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05373017
- Sponsor's protocol ID
- 2022-0545
- Other IDs
- A539714, Protocol Version 4/20/2025, SMPH/SURGERY/TRAUMA, 1R01AG076489-01
- Status last verified
- Apr 2026
- First submitted
- 5 May 2022
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gardner L, Bylund P, Robbins S, Holler E, Shojaei F, Shojaei F, Seidman M, Holden RJ, Fowler NR, Zarzaur B, Barboi C, Boustani M. Agile monitoring dashboard for clinical research studies. Trials. 2024 Nov 29;25(1):802. doi: 10.1186/s13063-024-08646-0.
PubMed 39609928Mohanty S, Holler E, Ortiz D, Meagher A, Perkins A, Bylund P, Khan B, Unverzagt F, Xu H, Ingraham A, Boustani M, Zarzaur B. Delirium and neuropsychological recovery among emergency general surgery survivors (DANE): study protocol for a randomized controlled trial and collaborative care intervention. Trials. 2023 Oct 3;24(1):634. doi: 10.1186/s13063-023-07670-w.
PubMed 37789461Mohanty S, Holler E, Ortiz D, Meagher A, Perkins A, Bylund P, Khan B, Unverzagt F, Xu H, Ingraham A, Boustani M, Zarzaur B. Delirium and Neuropsychological Recovery among Emergency General Surgery Survivors (DANE): study protocol for a randomized controlled trial and collaborative care intervention. Res Sq [Preprint]. 2023 Sep 7:rs.3.rs-3185716. doi: 10.21203/rs.3.rs-3185716/v1.
PubMed 37720054
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delirium and Neuropsychological Recovery Among Emergency General Surgery Survivors (DANE)
- ClinicalTrials.gov ID
- NCT05373017
- Acronym / sponsor ID
- 2022-0545
- Conditions
- Delirium
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 528 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Indiana University, National Institute on Aging (NIA)
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 13 May 2022 (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.
This study will evaluate the usefulness of the Urgent and Emergency Surgery (UES) Delirium Recovery Model. It is hypothesized that the cognitive, physical and psychological recovery of older UES delirium survivors will be improved through the use of the DANE Recovery Model. Participants can expect to be on the study for 18 months.
Detailed description
This is a multi-site, two-arm, single-blinded randomized controlled clinical trial to evaluate the efficacy of the DANE Recovery Model to improve the cognitive, physical and psychological recovery of older UES delirium survivors. At or near the time of discharge, enrolled participants will be randomized to receive the DANE Recovery Model or usual care. The hypothesis is that, after 18 months, older UES delirium survivors who are randomized to the DANE Recovery Model will experience more favorable cognitive, physical and psychological recovery in comparison to those randomized to usual care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DANE Recovery Model | Experimental | Other: DANE Recovery ProgramThe delivery of the model will occur in five phases that correspond to the known stages of recovery after surgery. During the acute stage (0 - 1 month after surgery), participants will undergo the initial case review and two initial virtual visits, and the development of the recovery care plan. During the recovery (2 - 6 months after surgery) and maintenance (7-12 months after surgery) stages, the participants will undergo the interaction phase of the DANE Recovery Model. |
| Usual Care | Other | Other: DANE Recovery Program, Other: QuestionnairesParticipants will receive the usual rehabilitation and post-operative care. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Adult age 65 years and older
- Admitted to one of the participating hospitals
- Undergone an abdominal orthopedic, skin, or vascular surgery in an emergency or unplanned fashion
- English-speaking
- Able to provide consent or have a legally authorized representative to provide consent
Key exclusion criteria (7 listed)
- A self-reported diagnosis of cancer with short life expectancy
- A history of dementing illnesses and other neurodegenerative disease such as Alzheimer's disease (AD), Parkinson disease, or vascular dementia, or current prescription of anti-dementia medication, or ruled out by Functional Activities Questionnaire (FAQ) score defining dementia; a history of significant traumatic brain injury
- Acute or subacute neurologic deficit expected to prevent independent living after hospital discharge, e.g., a history of a significant traumatic brain injury
- Have any spinal cord injury with persistent neurologic deficit at the time of study enrollment
- Incarcerated or homeless at the time of study enrollment
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 |
|---|---|---|
| DANE Recovery ProgramVirtual visits with care coordinator to carry out an individualized recovery plan | Other | DANE Recovery Model, Usual Care |
| QuestionnairesPhysical, cognitive, and psychological assessments | Other | Usual Care |
Primary outcome
Change in overall cognitive recovery
Time frame: Baseline, 6 months, 12 months, and 18 months
Change in score on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) cognitive screening assessment. The measure consists of 12 subtests that contribute to a total score and Index scores across five domains: Immediate Memory, Visuospatial-Constructional, Language, Attention, and Delayed Memory. Index scores are converted to age-based standard scores (Mean = 100, Standard Deviation = 15)
4 secondary outcomes
Short Physical Performance Battery (SPPB)
Time frame: Baseline, 6 months, 12 months, and 18 months
Change in overall physical recovery
Time frame: Baseline, 6 months, 12 months, and 18 months
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline, 6 months, 12 months, and 18 months
General Anxiety Disorder-7 (GAD-7) .
Time frame: Baseline, 6 months, 12 months, and 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Derived from this study: PubMed 39609928Gardner L, Bylund P, Robbins S, Holler E, Shojaei F, Shojaei F, Seidman M, Holden RJ, Fowler NR, Zarzaur B, Barboi C, Boustani M. Agile monitoring dashboard for clinical research studies. Trials. 2024 Nov 29;25(1):802. doi: 10.1186/s13063-024-08646-0.
- Derived from this study: PubMed 37789461Mohanty S, Holler E, Ortiz D, Meagher A, Perkins A, Bylund P, Khan B, Unverzagt F, Xu H, Ingraham A, Boustani M, Zarzaur B. Delirium and neuropsychological recovery among emergency general surgery survivors (DANE): study protocol for a randomized controlled trial and collaborative care intervention. Trials. 2023 Oct 3;24(1):634. doi: 10.1186/s13063-023-07670-w.
- Derived from this study: PubMed 37720054Mohanty S, Holler E, Ortiz D, Meagher A, Perkins A, Bylund P, Khan B, Unverzagt F, Xu H, Ingraham A, Boustani M, Zarzaur B. Delirium and Neuropsychological Recovery among Emergency General Surgery Survivors (DANE): study protocol for a randomized controlled trial and collaborative care intervention. Res Sq [Preprint]. 2023 Sep 7:rs.3.rs-3185716. doi: 10.21203/rs.3.rs-3185716/v1.
- Individual participant dataSharing planned: No
Related trials for Delirium
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
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.
Ben Zarzaur, MD principal investigator
University of Wisconsin, Madison
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DANE Recovery Program and Questionnaires in people with Delirium, run by University of Wisconsin, Madison at 6 sites 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 8 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in overall cognitive recovery (time frame: Baseline, 6 months, 12 months, and 18 months). 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 NCT05373017, which also lists 3 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 7 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.