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CompletedNCT02838511Updated Nov 4, 2019

Measure of Frailty in Perioperative Setting

An observational study in Frailty, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-04.

Sponsored by The Cleveland Clinic · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,190
Ages
18 Years and older
Sex
All
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Study summary

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).

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Conditions studied

  • Frailty

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In context

Frailty

1,199 studies on the registry are indexed under Frailty; 430 are open to participants now.

This study's enrollment of 1,190 is above the median of 223 across 496 observational studies indexed under Frailty.

Browse Frailty studies →

Lead sponsor

The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.

Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All adult patients presenting to pre anesthesia evaluation clinic at Cleveland clinic main campus.

Inclusion criteria

  • adult patients (18-100 years of age)
  • patients presenting to the PACE clinic for non cardiac surgery

Exclusion criteria

Exclusion Criteria:

  • children (under 18 years of age)
  • patients presenting to the PACE clinic for cardiac surgery
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,190 participants (actual)
Patient registry
No

Groups and cohorts

  • Non-cardiac surgery

    Hopkins Frailty Score (HFS) or Modified Frailty Index (MFI) will be obtained during during pre anesthesia evaluation

    Other: Modified Frailty Index (MFI) · Other: Hopkins Frailty Score (HFS)

Interventions

  • OtherModified Frailty Index (MFI)

    non-cardiac surgical patients will have frailty evaluated

  • OtherHopkins Frailty Score (HFS)

    non-cardiac surgical patients will have frailty evaluated

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What researchers measure

Primary outcomes

  1. Days in Hospital

    total number of days spent by patient in the hospital within 30 days of non-cardiac surgery

    Time frame: 30 days after non-cardiac surgery

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Study locations

1 site
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02838511
Lead sponsor
The Cleveland Clinic
Responsible party
Sponsor
First posted
Jul 20, 2016
Start date
Jan 2015
Primary completion
Aug 2019
Completion
Sep 2019
Last update
Nov 4, 2019

Study contacts

Daniel Sessler, M.D.
study chair · The Cleveland Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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