ADL and CONUT for Predicting 1-year Mortality Risk in Older Adults After Hip Fracture

October 30, 2023 updated by: Beijing Tongren Hospital

Beijing Tongren Hospital, Capital Medical University

Hip fracture has a serious impact on the quality of life and even the survival of older adults. The multidisciplinary management of hip fracture has been shown to be effective in improving patient outcome and cost-effective in international studies. As geriatricians and members of a multi-disciplinary team（MDT）, we are aware of various scores in predicting the 1-year mortality risk in hospitalized older adults with multimorbidity. However, given the need for a deeper understanding of the preoperative status of elderly patients who were suffering from pain, tension, anxiety, delirium,etc., we hope to explore a simple, quick, objective, and accurate method for assessing the status of elderly patients with hip fractures to predict their survival risk.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This was a single-center retrospective cohort study which were approved by the Clinical Research Ethics Committee of Beijing Tongren Hospital, Capital Medical University (TREC2023-KY026). Demographic characteristics and medical parameters, such as age, gender, body mass index (BMI), comorbidities, hemoglobin , lymphocytes, C-reactive protein (CRP), fasting blood glucose, creatinine, total protein, albumin, triglycerides, total cholesterol and American Association of Anesthesiologists (ASA) were collected from the electronic medical record system. Controlling nutritional status (CONUT) was calculated from 3 variables: serum albumin concentration, total cholesterol concentration, and lymphocyte count, as previously reported. All enrolled patients were followed-up in an outpatients setting. Survival data were obtained via direct contact with patients or patients' caregiver by their physicians at the hospital , or via telephone interview of their family by dedicated coordinators and investigators. The follow-up lasted for one year and the last follow-up was ended on December 31, 2022. All analyses were performed using SPSS version 19.0 (SPSS, Chicago, IL, USA).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
303

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Beijing Tongren Hospital, Capital Medical University
        • Contact:
          • Ying Chen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Older adults with unilateral hip fractures who received surgical treatment in our hospital from January 2014 to December 2021 were enrolled.

Description

Inclusion Criteria:

  1. patients aged ≧65 years old;
  2. patients diagnosed with hip fracture, including femoral neck fracture, femoral intertrochanteric fracture, and femoral subtrochanteric fracture;
  3. patients whose injury was within 21 days of presentation.

Exclusion Criteria:

  1. patients aged <65 years old;
  2. patients with pathological fractures due to tumor metastasis or infection or inherited bone disorder;
  3. patients with avascular necrosis of femoral head;
  4. patients with periprosthetic fractures;
  5. old fracture patients treated more than 21 days from injury;
  6. patients with severe trauma or fracture in other parts;
  7. patients and their families who could not bear the surgical risk and are unwilling to receive surgical treatment;
  8. patients died in hospital.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Death by 1 y
patients who dieded within 1-year after discharge due to hip fracture surgery
Other: no intervention
no intervention
Alive at 1 y
patients who survived 1-year after discharge due to hip fracture surgery
Other: no intervention
no intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: Calculated from the time of discharge, each patient was followed up 1 year, all-cause death in 1 year after discharge was counted.
After discharge, all enrolled patients were followed-up in an outpatients setting. Survival data were obtained via direct contact with patients or patients' caregiver by their physicians at the hospital , or via telephone interview of their family by dedicated coordinators and investigators. Survival data were obtained via direct contact with patients or patients' caregiver by their physicians at the hospital , or via telephone interview of their family by dedicated coordinators and investigators. Outcomes were recorded.
Calculated from the time of discharge, each patient was followed up 1 year, all-cause death in 1 year after discharge was counted.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Tongren Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: QI LIU, Beijing Tongren Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 31, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TREC2023-KY026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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