ClinicalTrials.gov
ClinicalTrials.gov Menu

Delirium Treatment With Acupuncture in Internal Medicine Departments

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03398928
Recruitment Status : Recruiting
First Posted : January 16, 2018
Last Update Posted : January 18, 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 time to delirium/subsyndromal delirium resolution and/or delirium severity's trajectory. Secondary outcomes will include changes between groups in cortisol (morning blood cortisol or midnight urinary cortisol/creatinine ratio), T3 levels, as well as length of hospital stay, functional status at discharge, destination after hospitalization and economic evaluation. All adverse events will be assessed daily.


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 Assessor-blinded 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. Time to delirium/subsyndromal delirium resolution [ Time Frame: 1 week ]
    Confusion Assessment Method scale

  2. Delirium severity's trajectory [ Time Frame: 1 week ]
    Confusion Assessment Method Severity scale


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 1 week ]
    Comparison of hospitalization-associated costs in the three study groups. These costs will be determined from individual ledger-level patient charges using cost-center-specific cost-to-charge ratios in year 2018 U.S. dollars. Average costs per hospital stay will be estimated by dividing the total hospitalization cost by the length of hospitalization. These estimates will be further classified into clinically meaningful cost subcategories: bed expenses, diagnostic procedures (laboratory, radiologic, etc.) and treatment-related (medications, physiotherapy, mechanical ventilation, etc.). For the intervention group (true acupuncture), costs associated with each acupuncture session including the expenses of acupuncturist salary (monthly salary divided by mean number of monthly acupuncture sessions) and needles (a mean of five per session) will be added.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  • International Normalized Ratio (INR) above 4
  • Partial Thromboplastin Time (PTT) above 80 seconds

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: January 18, 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