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Delirium Treatment With Acupuncture in Internal Medicine Departments

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ClinicalTrials.gov Identifier: NCT03398928
Recruitment Status : Recruiting
First Posted : January 16, 2018
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
Bnai Zion Medical Center

Brief Summary:
Delirium frequently occurs in hospitalized older people, and treatment options are limited. Acupuncture has been shown to reduce agitation in the setting of dementia. The investigators will test the hypothesis that it may also assist in treating delirium.

Condition or disease Intervention/treatment Phase
Delirium in Old Age Other: Acupuncture Other: Sham procedure Not Applicable

Detailed Description:

This assessor-blinded randomized sham-controlled trial aims to evaluate the efficacy of acupuncture integrated with standard care as compared to sham-acupuncture integrated with standard care or standard care only for the treatment of delirium in hospitalized older persons.

Patients aged 65 and older, hospitalized in the internal medicine departments of Bnai Zion Medical Center and diagnosed with delirium or subsyndromal delirium will be randomized to either true acupuncture with usual care, sham procedure with usual care or usual care only. Daily treatments and outcomes' follow-up will be conducted up to one week from recruitment or until resolution of delirium or subsyndromal delirium for 48 hours.

The primary outcome will be between-groups comparison of the changes in delirium severity over time as defined by continuous variations in CAM-S scores (trajectory). Secondary outcomes will include time to first delirium resolution, percentage of delirium-free days in the one-week period, number of days in which psychotropic and antipsychotic drugs were used in the one-week evaluation period, changes between groups in pain, sleep, morning blood cortisol and T3 as well as midnight urinary cortisol/creatinine ratio, delirium complications, in-hospital mortality, length of hospital stay and functional status at discharge. Side effects will be monitored daily. The cost-effectiveness of acupuncture treatment of delirium will be also estimated.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Delirium Treatment With Acupuncture in Internal Medicine Departments: a Randomized Sham-controlled Clinical Trial
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture Delirium

Arm Intervention/treatment
Experimental: Acupuncture
Acupuncture for delirium treatment
Other: Acupuncture
Sham Comparator: Sham procedure
Ear stimulation with plastic tape
Other: Sham procedure
Ear stimulation with plastic tape

No Intervention: Standard care
Standard conventional delirium care at the discretion of the department medical staff



Primary Outcome Measures :
  1. Change in delirium severity [ Time Frame: At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study ]
    Change in Confusion Assessment Method Severity scale - This tool includes 10 delirium-related items, the first one being rated on a 0-1 scale and the nine followings in a 0-2 scale for a total 0-19 score. Higher scores indicate worse outcomes.


Secondary Outcome Measures :
  1. Cortisol [ Time Frame: At baseline, day 4 and day 7 of the study ]
    Morning blood cortisol or midnight urinary cortisol/creatinine ratio

  2. T3 [ Time Frame: At baseline, day 4 and day 7 of the study ]
    T3 level

  3. Length of hospital stay [ Time Frame: Through study completion, an average of 1 week ]
    Days of hospitalization

  4. Functional status at discharge [ Time Frame: Through study completion, an average of 1 week ]
    Katz Activity of Daily Living (ADL) at discharge

  5. Destination after hospitalization [ Time Frame: Through study completion, an average of 1 week ]
    Home, nursing home, rehabilitation

  6. Economic evaluation [ Time Frame: Through study completion, an average of 3 months ]
    Incremental cost-effectiveness ratio (ICER) will be calculated by dividing the delta costs by the delta Quality-Adjusted Life Years (QALY)

  7. Time to delirium/subsyndromal delirium resolution [ Time Frame: At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study ]
    Confusion Assessment Method scale - a validated diagnostic tool addressing the four features of delirium (acute and fluctuating course, inattention, disorganized thinking and impaired level of consciousness). Definite delirium is defined as the first two features plus either one of the third or fourth, while subsyndromal delirium includes patients not meeting these diagnosis criteria but displaying two or more of these four features including the first one (acute and fluctuating course).

  8. Percentage of delirium or subsyndromal delirium-free days [ Time Frame: At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study ]
    Confusion Assessment Method scale - a validated diagnostic tool addressing the four features of delirium (acute and fluctuating course, inattention, disorganized thinking and impaired level of consciousness). Definite delirium is defined as the first two features plus either one of the third or fourth, while subsyndromal delirium includes patients not meeting these diagnosis criteria but displaying two or more of these four features including the first one (acute and fluctuating course).

  9. Number of days in which psychotropic and antipsychotic drugs were used [ Time Frame: At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study ]
    Daily patient chart review for psychotropic and antipsychotic drugs

  10. Visual Assessment Scale (VAS) for pain [ Time Frame: At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study ]
    Twice daily Visual Assesment Scale - This scale measures pain in a 0-10 score. Higher scores indicate worse pain.

  11. Sleep [ Time Frame: At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study ]
    Confusion Assessment Method Severity (CAM-S) scale, tenth item: "sleep-wake cycle". The CAM-S includes 10 delirium-related items, the first one being rated on a 0-1 scale and the nine followings in a 0-2 scale for a total 0-19 score. Here we will use the tenth item (sleep-wake cycle) rated on a 0-2 scale, higher scores indicating worse outcomes.

  12. Delirium complications [ Time Frame: At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study ]
    Falls, pulling out lines, pressure ulcers, physical restraints

  13. Mortality [ Time Frame: Through study completion, an average of 3 months ]
    Patient death



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hospitalized in internal medicine department
  • Aged over 65 years
  • Delirium or subsyndromal delirium within the last 48 hours
  • Signed informed consent by patient and/or next-of-kin

Exclusion Criteria:

  • Platelet count under 20x10^9/L
  • Encephalopathy explained by a cause other than delirium (acute stroke, alcohol, cirrhosis, etc.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03398928


Contacts
Contact: Elad Schiff, M.D. 972-506267243 elad.schiff@b-zion.org.il
Contact: Ilana Levy, M.D. 972-525086128 ilana.e.levy@gmail.com

Locations
Israel
Bnai Zion Medical Center Recruiting
Haifa, Golomb 47, Israel, 3104802
Contact: Ilana Levy, M.D.    972-525086128    ilana.e.levy@gmail.com   
Sponsors and Collaborators
Bnai Zion Medical Center
Investigators
Principal Investigator: Elad Schiff, M.D. Bnai Zion Medical Center

Responsible Party: Bnai Zion Medical Center
ClinicalTrials.gov Identifier: NCT03398928     History of Changes
Other Study ID Numbers: 0102-14-BNZ
First Posted: January 16, 2018    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders