NCT03398928

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 31, 2017

Completed
14 days until next milestone

Study Start

First participant enrolled

January 14, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 16, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
4 months until next milestone

Results Posted

Study results publicly available

September 18, 2020

Completed
Last Updated

September 18, 2020

Status Verified

December 1, 2017

Enrollment Period

1.9 years

First QC Date

December 31, 2017

Results QC Date

June 23, 2020

Last Update Submit

August 30, 2020

Conditions

Delirium in Old Age

Outcome Measures

Primary Outcomes (2)

  • 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).

    At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study

  • 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).

    At baseline, day 1, day 2, day 3, day 4, day 5, day 6, day 7 of the study

Secondary Outcomes (8)

  • Length of Hospital Stay

    Through study completion, an average of 2-3 weeks

  • Functional Status at Discharge

    Through study completion, an average of 2-3 weeks

  • Delirium Severity

    Sum of CAM-S at day 2 + day 3 + day 4 + day 5 + day 6 + day 7 of the study

  • Number of Days in Which Antipsychotic Drugs Were Used

    At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study

  • Visual Assessment Scale (VAS) for Pain

    At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study

  • +3 more secondary outcomes

Study Arms (2)

Acupuncture

EXPERIMENTAL

Acupuncture for delirium treatment

Other: Acupuncture

Standard care

NO INTERVENTION

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

Interventions

AcupunctureOTHER

Acupuncture added to usual care

Acupuncture

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bnai Zion Medical Center

Haifa, Golomb 47, 3104802, Israel

Location

Related Publications (1)

  • 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.

    PMID: 33685268DERIVED

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Results Point of Contact

Title
Prof. Elad Schiff
Organization
Bnai Zion Medical Center
elad.schiff@b-zion.org.il
972-506267243

Study Officials

  • Elad Schiff, M.D.

    Bnai Zion Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 31, 2017

First Posted

January 16, 2018

Study Start

January 14, 2018

Primary Completion

December 1, 2019

Study Completion

June 1, 2020

Last Updated

September 18, 2020

Results First Posted

September 18, 2020

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)