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Delirium Treatment With Acupuncture in Internal Medicine Departments

Primary Purpose

Delirium in Old Age

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
Bnai Zion Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Delirium in Old Age

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Hospitalized in internal medicine department
  • Aged over 65 years
  • Delirium or subsyndromal delirium within the last 48 hours

Exclusion Criteria:

  • Platelet count under 20x10^9/L
  • Encephalopathy explained by a cause other than delirium (acute stroke, alcohol, cirrhosis, etc.)
  • History of severe dementia
  • Communication barriers preventing delirium assessment

Sites / Locations

  • Bnai Zion Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Acupuncture

Standard care

Arm Description

Acupuncture for delirium treatment

Standard conventional delirium care at the discretion of the department medical staff

Outcomes

Primary Outcome Measures

Number of Delirium-free Days During the 7 Days of Evaluation
Number of delirium-free days, based on daily assessment of 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).
Time-to-first Remission of Delirium in the 7 Days of Evaluation
Daily assessment of 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).

Secondary Outcome Measures

Length of Hospital Stay
Days of hospitalization
Functional Status at Discharge
Total Katz Activity of Daily Living (ADL) score at discharge - score assessing activities of daily living, minimum: 0 (worse prognosis), maximum: 6 (best prognosis), calculated as the sum of the following activities (1: independence, 0: dependence): bathing, dressing, toileting, transferring, continence, feeding.
Delirium Severity
Comparison of the sum of long Confusion Assessment Method (CAM-S) score from day 2 (before treatment in the second day of the study) until day 7 (last day of evaluation). CAM-S scale 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. When summed across 7 days, the total scale range is 0-133 with 0-3 being no delirium, 4-6 being low severity, 7-13 being moderate severity and +/=14 being high severity (Vasunilashorn SM, Marcantonio ER, Gou Y, et al. Quantifying the Severity of a Delirium Episode Throughout Hospitalization: the Combined Importance of Intensity and Duration. J Gen Intern Med. 2016;31(10):1164-1171).
Number of Days in Which Antipsychotic Drugs Were Used
Daily patient chart review for antipsychotic drugs
Visual Assessment Scale (VAS) for Pain
Daily Visual Assesment Scale - This scale measures pain in a 0-10 score. Higher scores indicate worse pain.
Sleep
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.
Delirium Complications
Falls, pulling out lines, pressure ulcers, physical restraints
Mortality
Patient death

Full Information

First Posted
December 31, 2017
Last Updated
August 30, 2020
Sponsor
Bnai Zion Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03398928
Brief Title
Delirium Treatment With Acupuncture in Internal Medicine Departments
Official Title
Delirium Treatment With Acupuncture in Internal Medicine Departments: a Randomized Sham-controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
January 14, 2018 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
June 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bnai Zion Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This randomized-controlled trial aims to evaluate the efficacy of acupuncture integrated with standard care as compared to 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, 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 delirium resolution evaluated as time-to-first delirium remission (over 7 days) and the number of days spent delirium-free.Side effects will be monitored daily.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium in Old Age

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
Acupuncture for delirium treatment
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Standard conventional delirium care at the discretion of the department medical staff
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
Acupuncture added to usual care
Primary Outcome Measure Information:
Title
Number of Delirium-free Days During the 7 Days of Evaluation
Description
Number of delirium-free days, based on daily assessment of 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).
Time Frame
At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study
Title
Time-to-first Remission of Delirium in the 7 Days of Evaluation
Description
Daily assessment of 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).
Time Frame
At baseline, day 1, day 2, day 3, day 4, day 5, day 6, day 7 of the study
Secondary Outcome Measure Information:
Title
Length of Hospital Stay
Description
Days of hospitalization
Time Frame
Through study completion, an average of 2-3 weeks
Title
Functional Status at Discharge
Description
Total Katz Activity of Daily Living (ADL) score at discharge - score assessing activities of daily living, minimum: 0 (worse prognosis), maximum: 6 (best prognosis), calculated as the sum of the following activities (1: independence, 0: dependence): bathing, dressing, toileting, transferring, continence, feeding.
Time Frame
Through study completion, an average of 2-3 weeks
Title
Delirium Severity
Description
Comparison of the sum of long Confusion Assessment Method (CAM-S) score from day 2 (before treatment in the second day of the study) until day 7 (last day of evaluation). CAM-S scale 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. When summed across 7 days, the total scale range is 0-133 with 0-3 being no delirium, 4-6 being low severity, 7-13 being moderate severity and +/=14 being high severity (Vasunilashorn SM, Marcantonio ER, Gou Y, et al. Quantifying the Severity of a Delirium Episode Throughout Hospitalization: the Combined Importance of Intensity and Duration. J Gen Intern Med. 2016;31(10):1164-1171).
Time Frame
Sum of CAM-S at day 2 + day 3 + day 4 + day 5 + day 6 + day 7 of the study
Title
Number of Days in Which Antipsychotic Drugs Were Used
Description
Daily patient chart review for antipsychotic drugs
Time Frame
At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study
Title
Visual Assessment Scale (VAS) for Pain
Description
Daily Visual Assesment Scale - This scale measures pain in a 0-10 score. Higher scores indicate worse pain.
Time Frame
At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study
Title
Sleep
Description
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.
Time Frame
At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study
Title
Delirium Complications
Description
Falls, pulling out lines, pressure ulcers, physical restraints
Time Frame
At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study
Title
Mortality
Description
Patient death
Time Frame
During the 7-day intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hospitalized in internal medicine department Aged over 65 years Delirium or subsyndromal delirium within the last 48 hours Exclusion Criteria: Platelet count under 20x10^9/L Encephalopathy explained by a cause other than delirium (acute stroke, alcohol, cirrhosis, etc.) History of severe dementia Communication barriers preventing delirium assessment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elad Schiff, M.D.
Organizational Affiliation
Bnai Zion Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bnai Zion Medical Center
City
Haifa
State/Province
Golomb 47
ZIP/Postal Code
3104802
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33685268
Citation
Levy I, Gavrieli S, Hefer T, Attias S, Schiff A, Oliven R, Wisberg-Levi S, Hanchinsky R, Schiff E. Acupuncture Treatment of Delirium in Older Adults Hospitalized in Internal Medicine Departments: An Open-Label Pragmatic Randomized-Controlled Trial. J Geriatr Psychiatry Neurol. 2022 May;35(3):333-343. doi: 10.1177/0891988721996804. Epub 2021 Mar 9.
Results Reference
derived

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Delirium Treatment With Acupuncture in Internal Medicine Departments

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