Association of Frailty and Delirium in Elderly Hip Fracture Patients

NCT ID: NCT05246254

Last Updated: 2023-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-01

Study Completion Date

2024-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Delirium in Old Age Frailty

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Prefrailty group

According to the frailty index(FI) and FI =0.12\~0.25

Frailty index scale

Intervention Type DIAGNOSTIC_TEST

There are clinically common scales for assessing weakness and delirium.

Frailty group

According to the frailty index(FI) and FI≥ 0.25

Frailty index scale

Intervention Type DIAGNOSTIC_TEST

There are clinically common scales for assessing weakness and delirium.

Nonfrailty group

According to the frailty index(FI) and FI\<0.12

Frailty index scale

Intervention Type DIAGNOSTIC_TEST

There are clinically common scales for assessing weakness and delirium.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Frailty index scale

There are clinically common scales for assessing weakness and delirium.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CAM scale Nu-DESC sclae

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beijing Municipal Administration of Hospitals

OTHER_GOV

Sponsor Role collaborator

Beijing Tsinghua Chang Gung Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Huan Zhang, PhD

Role: PRINCIPAL_INVESTIGATOR

Beijing Tsinghua Changgeng Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Huan Zhang, PhD

Role: CONTACT

(010)17600809297

Haotian Wu, MD

Role: CONTACT

(010)56119357

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Huan Zhang, PhD

Role: primary

(010)17600809297

Haotian Wu, MD

Role: backup

(010)56119357

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BTCH-MZ-007

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Frailty and Postoperative Shock
NCT02669927 COMPLETED