Delirium in Old AgeNCT05246254
Association of Frailty and Delirium in Elderly Hip Fracture Patients
An observational study of Delirium in Old Age and Frailty, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
Trial summary
Several studies have shown that frailty can be used as a marker for risk of adverse outcomes in elderly patients such as falls, disability, hospitalization, mortality, and can be used to predict patient clinical outcomes. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Delirium in Old Age, Frailty
- What is being tested?
- Frailty index scale
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2022to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients over the age of 65 who underwent surgery for hip fractures
Who may be able to join
- The subjects were patients with hip fracture;
- Older than 65 years;
- Patients signed informed consent;
- American Society of Anesthesiologist (ASA) Rated I- III;
- The surgery was performed by the same anesthesia and surgical team.
Who cannot join
- Patients cannot sign the consent form or refuse to participate;
- A history of cognitive impairment;
- Unable to complete the cognitive function test;
- Mental disorder during initial assessment;
- Patients suffering from mental illness or substance use disorder;
- Incomplete or lost data during follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 100018
Huan Zhang, PhD, (010)17600809297, whta01956@btch.edu.cn
Haotian Wu, MD, (010)56119357, tatabox@163.com
About this study
Official title: The Association of Preoperative Frailty Index and Incidence of Postoperative Delirium in Elderly Patients With Hip Fracture: a Prospective Cohort Study
Several studies have shown that frailty can be used as a marker for risk of adverse outcomes in elderly patients such as falls, disability, hospitalization, mortality, and can be used to predict patient clinical outcomes. The purpose of this study is to determine whether preoperative frailty can be used as a diagnostic and predictive factor for postoperative delirium in elderly patients with hip fracture.
Read the detailed description
Frailty index (FI) is a reliable method to determine the assessment of frailty in elderly patients. Multiple prospective cohort studies have shown that frailty can be used as a marker for risk of adverse outcomes in older adults such as falls, disability, hospitalization, and mortality, and can be used to predict patient clinical outcomes. Whether frailty could be used as a diagnostic and predictive factor for delirium is urgently needed in a large population.
Therefore, this project intends to conduct a prospective cohort study. Patients will be divided into three groups according to frailty index (FI) before surgery, and delirium status will be evaluated by using scales after surgery, so as to explore the diagnostic and predictive value of frailty on POD. Once confirmed, the results of this study will be helpful for the early identification, screening, diagnosis and evaluation of treatment effect of POD. It is of great scientific significance and social benefit to reduce the incidence of POD, improve the prognosis of vulnerable patients and reduce the burden of disease.
- Conditions
- Delirium in Old Age, Frailty
- Being tested
- Frailty index scale
- Keywords
- frailty, postoperative delirium, hip fracture, elderly
- Medical subject headings
- Frailty, Emergence Delirium, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frailty index scaleDiagnostic test
Also called CAM scale, Nu-DESC sclae
There are clinically common scales for assessing weakness and delirium.
| Study group | Role | What they receive |
|---|---|---|
| Prefrailty group | According to the frailty index(FI) and FI =0.12~0.25 Receives: Diagnostic Test: Frailty index scale | |
| Frailty group | According to the frailty index(FI) and FI≥ 0.25 Receives: Diagnostic Test: Frailty index scale | |
| Nonfrailty group | According to the frailty index(FI) and FI<0.12 Receives: Diagnostic Test: Frailty index scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative delirium（POD） in elderly patients with hip fracture
The percentage of the study population who developed delirium within seven days of surgery,postoperative delirium（POD） is defined according to the CAM criterion
Measured: Postoperative 7 days
Secondary outcomes (7)
Duration of delirium
The time between the first appearance of delirium
Measured: Postoperative 7 days
Delirium drug use
dosage and name of medication prescribed by a neurologist
Measured: Postoperative 7 days
Length of hospital stay (HLOS)
Collection of clinical data in the medical record
Measured: Postoperative 30 days
Length of ICU stay
Collection of clinical data in the medical record
Measured: Postoperative 30 days
Hospital cost
Expenses during hospitalization
Measured: Postoperative 30 days
Dindo-Clavien Classification{References:Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 2004; 240(2):205-213.}
Incidence of serious adverse reactions within 30 days after operation （the therapy used to correct a specific complication is the basis of this classification in order to rank a complication in an objective and reproducible manner.
It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). The introduction of the subclasses a and b allows a contraction of the classification into 5 grades (I, II, III, IV and V) depending on the size of the population observed or the of the focus of a study.
Complications that have the potential for long-lasting disability after patient's discharge are highlighted in the present classification by a suffix ("d" for disability). This suffix indicates that a follow-up is required to comprehensively evaluate the outcome and related long-term quality of life.）
Measured: Postoperative 30 days
Death before and 30 days after discharge
Collection of clinical data in the medical record and follow-up update through telephone
Measured: 30 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start1 Feb 2022
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium in Old AgeStudies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Municipal Administration of Hospitals
- Responsible party
- Sponsor
- Investigators
- Huan Zhang, PhD, Principal investigator, Beijing Tsinghua Changgeng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05246254
- Sponsor's protocol ID
- BTCH-MZ-007
- Status last verified
- Feb 2023
- First submitted
- 12 Jan 2022
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Preoperative Frailty Index and Incidence of Postoperative Delirium in Elderly Patients With Hip Fracture: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05246254
- Acronym / sponsor ID
- BTCH-MZ-007
- Conditions
- Delirium in Old Age, Frailty
- Keywords
- frailty, postoperative delirium, hip fracture, elderly
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Collaborators
- Beijing Municipal Administration of Hospitals
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 18 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Several studies have shown that frailty can be used as a marker for risk of adverse outcomes in elderly patients such as falls, disability, hospitalization, mortality, and can be used to predict patient clinical outcomes. The purpose of this study is to determine whether preoperative frailty can be used as a diagnostic and predictive factor for postoperative delirium in elderly patients with hip fracture.
Detailed description
Frailty index (FI) is a reliable method to determine the assessment of frailty in elderly patients. Multiple prospective cohort studies have shown that frailty can be used as a marker for risk of adverse outcomes in older adults such as falls, disability, hospitalization, and mortality, and can be used to predict patient clinical outcomes. Whether frailty could be used as a diagnostic and predictive factor for delirium is urgently needed in a large population.
Therefore, this project intends to conduct a prospective cohort study. Patients will be divided into three groups according to frailty index (FI) before surgery, and delirium status will be evaluated by using scales after surgery, so as to explore the diagnostic and predictive value of frailty on POD. Once confirmed, the results of this study will be helpful for the early identification, screening, diagnosis and evaluation of treatment effect of POD. It is of great scientific significance and social benefit to reduce the incidence of POD, improve the prognosis of vulnerable patients and reduce the burden of disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prefrailty group | – | Diagnostic Test: Frailty index scaleAccording to the frailty index(FI) and FI =0.12~0.25 |
| Frailty group | – | Diagnostic Test: Frailty index scaleAccording to the frailty index(FI) and FI≥ 0.25 |
| Nonfrailty group | – | Diagnostic Test: Frailty index scaleAccording to the frailty index(FI) and FI<0.12 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients over the age of 65 who underwent surgery for hip fractures
Key inclusion criteria (5 listed)
- The subjects were patients with hip fracture;
- Older than 65 years;
- Patients signed informed consent;
- American Society of Anesthesiologist (ASA) Rated I- III;
- The surgery was performed by the same anesthesia and surgical team.
Key exclusion criteria (6 listed)
- Patients cannot sign the consent form or refuse to participate;
- A history of cognitive impairment;
- Unable to complete the cognitive function test;
- Mental disorder during initial assessment;
- Patients suffering from mental illness or substance use disorder;
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 |
|---|---|---|
| Frailty index scaleAlso: CAM scale, Nu-DESC sclaeThere are clinically common scales for assessing weakness and delirium. | Diagnostic test | Frailty group, Nonfrailty group, Prefrailty group |
Primary outcome
Incidence of postoperative delirium（POD） in elderly patients with hip fracture
Time frame: Postoperative 7 days
The percentage of the study population who developed delirium within seven days of surgery,postoperative delirium（POD） is defined according to the CAM criterion
7 secondary outcomes
Duration of delirium
Time frame: Postoperative 7 days
Delirium drug use
Time frame: Postoperative 7 days
Length of hospital stay (HLOS)
Time frame: Postoperative 30 days
Length of ICU stay
Time frame: Postoperative 30 days
Hospital cost
Time frame: Postoperative 30 days
Dindo-Clavien Classification{References:Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 2004; 240(2):205-213.}
Time frame: Postoperative 30 days
Death before and 30 days after discharge
Time frame: 30 days after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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.
Huan Zhang, PhD principal investigator
Beijing Tsinghua Changgeng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium in Old Age and Frailty, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 31 Oct 2023. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huan Zhang, PhD ((010)17600809297, whta01956@btch.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative delirium（POD） in elderly patients with hip fracture (time frame: Postoperative 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Oct 2023.