NCT04515160

Brief Summary

The purpose of our study is to evaluate the correlation of the Clinical Frailty Scale, which is a judgment-based measure, and the Modified Frailty Index, which interrogates the patient's current diseases, in the frailty assessment of intensive care patients and the effect on the estimation of mortality, mechanical ventilation need, intensive care stay, hospital stay and discharge status.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 13, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 17, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

September 8, 2021

Status Verified

September 1, 2021

Enrollment Period

1 year

First QC Date

August 13, 2020

Last Update Submit

September 6, 2021

Conditions

Frailty

Outcome Measures

Primary Outcomes (1)

  • Frailty

    the correlation of the Clinical Frailty Scale, which is a judgment-based measure, and the Modified Frailty Index, which interrogates the patient's current diseases, in the frailty assessment of intensive care patients

    in the first 24 hours of intensive care admissions

Secondary Outcomes (3)

  • mortality

    the patient will be monitored for 1 year and the exitus time will be recorded

  • intensive care stay

    the patient will be monitored for 1 year and the intensive care stay will be recorded

  • discharge status

    the patient will be monitored for 1 year and the discharge status will be recorded

Interventions

Clinical Frailty ScaleDIAGNOSTIC_TEST

Clinical fragility scale will be recorded in the first 24 hours of intensive care admissions.

Modified Frailty IndexDIAGNOSTIC_TEST

Modified Frailty Index will be recorded in the first 24 hours of intensive care admissions.

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

intensive care patients

You may qualify if:

  • intensive care patients

You may not qualify if:

  • patients with a life expectancy of less than 24 hours
  • Do not speak Turkish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DiskapiYBERH

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Bahar SAKIZCI UYAR

CONTACT

5057000240drsakizciuyar@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

August 13, 2020

First Posted

August 17, 2020

Study Start

July 1, 2020

Primary Completion

July 1, 2021

Study Completion

January 1, 2022

Last Updated

September 8, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)