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NCT02838511 · ClinicalTrials.gov registry record
Measure of Frailty in Perioperative Setting
A clinical trial of Frailty, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- 1,190
- Enrollment target
- 1
- Study location
NCT02838511 is a study of Frailty that has completed, run by The Cleveland Clinic. The registered enrollment target is 1,190 participants, below the 1,481-participant average among 48 other Frailty trials with a reported enrollment target (20% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02838511, a study of Frailty, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- 1,190 participants
- Enrollment target
- 1
- Study location
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 postoperativ
Conditions Studied
Interventions
- OTHER Modified Frailty Index (MFI)
- OTHER Hopkins Frailty Score (HFS)
Study Locations (1)
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,190 participants |
| Start Date | 2015-01 |
| Est. Completion | 2019-09 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02838511
The ClinicalTrials.gov registry entry for NCT02838511 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 1,190 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,481-participant average among 48 other Frailty trials with a reported enrollment target (20% lower). The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Frailty appearing as the primary indexed condition, and to 2 interventions - of which Modified Frailty Index (MFI) is the first listed.
NCT02838511 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT02838511 about?
NCT02838511 is a clinical study titled "Measure of Frailty in Perioperative Setting". 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...
What is the current status of trial NCT02838511?
This trial is currently completed. The enrollment target is 1,190 participants. The study started on 2015-01. Estimated completion is 2019-09.
What conditions does trial NCT02838511 study?
This clinical trial studies the following conditions: Frailty.
What interventions are being tested in trial NCT02838511?
The interventions under investigation include: Modified Frailty Index (MFI) (OTHER), Hopkins Frailty Score (HFS) (OTHER).
Who is sponsoring clinical trial NCT02838511?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02838511 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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