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Completed No phase listed Observational

Measure of Frailty in Perioperative Setting

ClinicalTrials.gov ID: NCT02838511

Public ClinicalTrials.gov record NCT02838511. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 4:24 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Which is a Better Measure of Frailty in Perioperative Setting: Deficit Accumulation Model or Phenotype Model?

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Though most physicians believe they can identify frail patients, frailty is a poorly characterized and complex clinical syndrome. Frailty has been categorized four dimensions by de Vries et al: 1) physical (physical activity, nutrition, mobility, strength and energy); 2) biochemical (nutritional and inflammatory biomarkers); 3) psychological (cognition and mood); and, 4) social (social contact and support). 1 However, the pathophysiology of frailty remains unclear. Two broad hypotheses have been proposed. Deficit accumulation model: This hypothesis assumes that frailty occurs due to accumulation and additive effect of multiple deficits, which occur across various domains. The more deficits a person has, the more likely that person is to be frail. Frailty in this paradigm is thus measured by identifying the number of positive factors/ deficits from a list. This is used to create a proportional index of deficits, expressed as the ratio of deficits present to the total number of deficits considered. Many studies have used a modified frailty index (MFI) with 11 factors, which has shown to correlate well with patient outcomes after surgery. Phenotype model: Fried et al in 2001 proposed a phenotype based model, in which she identified various clinical features that define frailty as a clinical syndrome. This criterion, known as Fried index, consists of 5 factors- shrinking, weakness, exhaustion, slowness, and low physical activity level. The Fried index is the most commonly used phenotype-based assessment tool to evaluate frailty. An advantage is its ease-of use during preoperative visits. Measurement of these factors in a perioperative setting was further characterized by Makary et al in 2010, and was the basis for the Hopkins Frailty Score (HFS). Currently, there exists no gold standard for assessment of frailty, especially in the perioperative setting. In the absence of a well-accepted gold standard, a measurement of frailty which would predict adverse postoperative outcomes would be useful. However, no study has compared the prognostic abilities of HFS and MFI, after non-cardiac surgery. All adult patients presenting to pre anesthesia evaluation clinic (PACE) at Cleveland Clinic main campus will be included in the this prospective observational cohort study. Frailty would be evaluated prospectively using HFS and components of MFI will be obtained from Cleveland Clinic Perioperative Health Documentation System registry (PHDS).

Study identification

NCT ID
NCT02838511
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
The Cleveland Clinic
Other
Enrollment
1,190 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 31, 2014
Primary completion
Jul 31, 2019
Completion
Aug 31, 2019
Last update posted
Nov 3, 2019

2015 – 2019

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Cleveland Clinic Cleveland Ohio 44195

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02838511, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 3, 2019 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02838511 live on ClinicalTrials.gov.

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