Delirium Treatment With Acupuncture in Internal Medicine Departments

Delirium in Old Age Clinical Trial

Official title:

Delirium Treatment With Acupuncture in Internal Medicine Departments: a Randomized Sham-controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03398928
• Other study ID #: 0102-14-BNZ
• Status: Completed
• Phase: N/A
• Start date: January 14, 2018
• Est. completion date: June 1, 2020

Study information

• Verified date: December 2017
• Source: Bnai Zion Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: June 1, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Delirium in Old Age

Intervention

Other:
• Acupuncture
Acupuncture added to usual care

Locations

Country	Name	City	State
Israel	Bnai Zion Medical Center	Haifa	Golomb 47

Sponsors (1)

Lead Sponsor	Collaborator
Bnai Zion Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Length of Hospital Stay	Days of hospitalization	Through study completion, an average of 2-3 weeks
Secondary	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.	Through study completion, an average of 2-3 weeks
Secondary	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).	Sum of CAM-S at day 2 + day 3 + day 4 + day 5 + day 6 + day 7 of the study
Secondary	Number of Days in Which Antipsychotic Drugs Were Used	Daily patient chart review for antipsychotic drugs	At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study
Secondary	Visual Assessment Scale (VAS) for Pain	Daily Visual Assesment Scale - This scale measures pain in a 0-10 score. Higher scores indicate worse pain.	At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study
Secondary	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.	At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study
Secondary	Delirium Complications	Falls, pulling out lines, pressure ulcers, physical restraints	At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study
Secondary	Mortality	Patient death	During the 7-day intervention