Clinical trial NCT03398928: 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
Overall status: COMPLETED
Phase: NA
Conditions: Delirium in Old Age
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2018-01-16
Enrollment: 81
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Delirium-free Days During the 7 Days of Evaluation
timeFrame: At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study
measure: Time-to-first Remission of Delirium in the 7 Days of Evaluation
timeFrame: At baseline, day 1, day 2, day 3, day 4, day 5, day 6, day 7 of the study
Secondary outcomes:
measure: Length of Hospital Stay
timeFrame: Through study completion, an average of 2-3 weeks
measure: Functional Status at Discharge
timeFrame: Through study completion, an average of 2-3 weeks
measure: Delirium Severity
timeFrame: Sum of CAM-S at day 2 + day 3 + day 4 + day 5 + day 6 + day 7 of the study
measure: Number of Days in Which Antipsychotic Drugs Were Used
timeFrame: At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study
measure: Visual Assessment Scale (VAS) for Pain
timeFrame: At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study
measure: Sleep
timeFrame: At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study
measure: Delirium Complications
timeFrame: At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study
measure: Mortality
timeFrame: During the 7-day intervention
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
state: Golomb 47
Study officials:
affiliation: Bnai Zion Medical Center
name: Elad Schiff, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.