NCT02966470

Brief Summary

This study aims to assess if grip strength can be used as a single, objective surrogate of frailty assessment in the surgical population.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

November 15, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2016

Completed
1.2 years until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2019

Completed
Last Updated

February 10, 2020

Status Verified

February 1, 2020

Enrollment Period

1.6 years

First QC Date

November 15, 2016

Last Update Submit

February 6, 2020

Conditions

Frailty

Keywords

surgical outcomes

Outcome Measures

Primary Outcomes (1)

  • linear regression of grip strength to frailty survey score

    Their frailty survey and grip strength scores will also be recorded for analysis. We will analyze the data by linear regression of grip strength to frailty survey score.

    10 minutes at the time of admission

Study Arms (1)

General surgery patient

General surgery patient admitted to the Section of General Surgery, Trauma, and Surgical Critical Care who are over 60.

Device: Obtain grip strength from a standardized gripometer

Interventions

Obtain grip strength from a standardized gripometerDEVICE

Obtain grip strength from a standardized gripometer, 3 times on each hand

General surgery patient

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

General surgery patients admitted to the Section of General Surgery, Trauma, and Surgical Critical Care who are over the age of 60.

You may qualify if:

  • General surgery patient admitted to the Section of General Surgery, Trauma, and Surgical Critical Care
  • Age \>60

You may not qualify if:

  • Pregnancy
  • Untreated or metastatic malignancy
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bishwajit Bhattacharya, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2016

First Posted

November 17, 2016

Study Start

February 1, 2018

Primary Completion

September 25, 2019

Study Completion

September 25, 2019

Last Updated

February 10, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)