Delirium in Old AgeNCT03398928
Delirium Treatment With Acupuncture in Internal Medicine Departments
A study testing Acupuncture in people with Delirium in Old Age, run by Bnai Zion Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Delirium in Old Age
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteIsrael
- Study dates
- 14 Jan 2018to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Hospitalized in internal medicine department
- Aged over 65 years
- Delirium or subsyndromal delirium within the last 48 hours
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Delirium Treatment With Acupuncture in Internal Medicine Departments: a Randomized Sham-controlled Clinical Trial
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.
Read the 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.
- Conditions
- Delirium in Old Age
- Being tested
- Acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Acupuncture added to usual care
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Acupuncture for delirium treatment Receives: Other: Acupuncture |
| Standard care | No intervention | Standard conventional delirium care at the discretion of the department medical staff |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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
Days of hospitalization
Measured: Through study completion, an average of 2-3 weeks
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.
Measured: Through study completion, an average of 2-3 weeks
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).
Measured: 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
Daily patient chart review for antipsychotic drugs
Measured: At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study
Visual Assessment Scale (VAS) for Pain
Daily Visual Assesment Scale - This scale measures pain in a 0-10 score. Higher scores indicate worse pain.
Measured: At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study
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.
Measured: At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study
Delirium Complications
Falls, pulling out lines, pressure ulcers, physical restraints
Measured: At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study
Mortality
Patient death
Measured: During the 7-day intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study start14 Jan 2018
- Primary completion1 Dec 2019
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Delirium in Old AgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Elad Schiff, M.D., Principal investigator, Bnai Zion Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398928
- Sponsor's protocol ID
- 0102-14-BNZ
- Status last verified
- Dec 2017
- First submitted
- 31 Dec 2017
- Last updated
- 18 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33685268
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delirium Treatment With Acupuncture in Internal Medicine Departments: a Randomized Sham-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03398928
- Acronym / sponsor ID
- 0102-14-BNZ
- Conditions
- Delirium in Old Age
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- 14 Jan 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 16 Jan 2018 (actual)
- Results
- Posted 18 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Other: AcupunctureAcupuncture for delirium treatment |
| Standard care | No intervention | –Standard conventional delirium care at the discretion of the department medical staff |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Hospitalized in internal medicine department
- Aged over 65 years
- Delirium or subsyndromal delirium within the last 48 hours
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureAcupuncture added to usual care | Other | Acupuncture |
Primary outcome
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).
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).
8 secondary outcomes
Length of Hospital Stay
Time frame: Through study completion, an average of 2-3 weeks
Functional Status at Discharge
Time frame: Through study completion, an average of 2-3 weeks
Delirium Severity
Time frame: 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
Time frame: At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study
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
Sleep
Time frame: At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study
Delirium Complications
Time frame: At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study
Mortality
Time frame: During the 7-day intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33685268Levy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elad Schiff, M.D. principal investigator
Bnai Zion Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Delirium in Old Age, run by Bnai Zion Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03398928, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2020.