Prevalence of Malnutrition and/or Sarcopenia at Hospital... | NCT02990520

Studies
Prevalence of Malnutrition and/or Sarcopenia at Hospital Admission

NCT02990520

Sponsor

The University of Texas Medical Branch, Galveston

Status

Completed

Last Update Posted

Dec 19, 2024Actual

Enrollment

190Actual

Phase

Not provided

Conditions

Malnutrition
Sarcopenia

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015Actual

Primary Completion Date

Jul 12, 2022Actual

Completion Date

Feb 2, 2024Actual

First Submitted Date

Sep 3, 2015

First Submission Date that Met QC Criteria

Dec 8, 2016

First Posted Date

Dec 13, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2024

Last Update Posted Date

Dec 19, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine the prevalence of malnutrition and/or sarcopenia at admission to the hospital in older adults.

Detailed Description

The primary outcome of this study is to determine the prevalence of malnutrition and/or sarcopenia at admission to the hospital in older adults. The secondary outcome is to assess the relationship between malnutrition/sarcopenia status and length of stay, comorbidity load, polypharmacy, and 30-day readmission.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

190Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of Malnutrition	malnutrition measured with questionnaires	baseline

Secondary Outcomes

Measure	Description	Time Frame
Prevalence of sarcopenia	Sarcopenia defined using the EWGSOP or IWGS or FNIH criteria	baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Admitted to the UTMB ACE unit
Aged 65 years or older
Able to consent to participate in study (alert and oriented x3)

Exclusion Criteria:

Because this study aims to determine prevalence of malnutrition and/or sarcopenia at admission to the hospital, patients will be excluded if study measures are not able to be taken within 72 hours of admission.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Hospitalized older adults

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elena Volpi, MD, PhD	UTMB	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UTMB Hospitals		Galveston	Texas	77555	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D044342	Malnutrition
D055948	Sarcopenia

Ancestor Terms

ID	Term
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D009133	Muscular Atrophy
D020879	Neuromuscular Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided