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Completed

NCT Number: NCT03398928

Delirium Treatment With Acupuncture in Internal Medicine Departments

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.

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Key information

Conditions

Delirium in Old Age

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bnai Zion Medical Center

Haifa, Golomb 47, 3104802, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupuncture

Other

Acupuncture added to usual care

Primary outcomes

  1. Number of Delirium-free Days During the 7 Days of Evaluation

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

    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).

  2. Time-to-first Remission of Delirium in the 7 Days of Evaluation

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

    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 outcomes

  1. Length of Hospital Stay

    Time frame: Through study completion, an average of 2-3 weeks

    Days of hospitalization

  2. Functional Status at Discharge

    Time frame: Through study completion, an average of 2-3 weeks

    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.

  3. Delirium Severity

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

    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).

  4. Number of Days in Which Antipsychotic Drugs Were Used

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

    Daily patient chart review for antipsychotic drugs

  5. Visual Assessment Scale (VAS) for Pain

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

    Daily Visual Assesment Scale - This scale measures pain in a 0-10 score. Higher scores indicate worse pain.

  6. Sleep

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

    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.

  7. Delirium Complications

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

    Falls, pulling out lines, pressure ulcers, physical restraints

  8. Mortality

    Time frame: During the 7-day intervention

    Patient death

Sponsors and collaborators

Lead sponsor

Bnai Zion Medical Center

Other Gov

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jan 16, 2018
Registry last updated
Sep 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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