Post - Hospital Syndrome: Profile of Functional Status by... | NCT03126500

Studies
Post - Hospital Syndrome: Profile of Functional Status by Malnutrition

NCT03126500

Sponsor

Charite University, Berlin, Germany

Status

Unknown status

Last Update Posted

Jan 28, 2020Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Malnutrition
Sarcopenia

Interventions

Not provided

Countries

Germany

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

Jan 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 31, 2017Actual

Primary Completion Date

Apr 30, 2021Estimated

Completion Date

Jun 30, 2021Estimated

First Submitted Date

Apr 12, 2017

First Submission Date that Met QC Criteria

Apr 20, 2017

First Posted Date

Apr 24, 2017Actual

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

Jan 27, 2020

Last Update Posted Date

Jan 28, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kristina Norman, PD Dr., Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Malnutrition is common problem in hospitalized geriatrics at discharge. Malnutrition is a high risk for functional limitations, impaired muscle strength and reduced quality of life.

Detailed Description

The majority of geriatric hospitalized patients are at high risk for malnutrition at discharge, which has negative impact on post-hospital outcomes. In a cross-sectional analysis in malnourished, geriatric patients we will evaluate frailty-status and functional status using objective and subjective methods at hospital discharge. Moreover, we will investigate the association between nutritional Status and frailty, sarcopenia, quality of life and fatigue.

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

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Malnourished		malnourished, geriatrics patients at hospital discharge

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Functional Parameter: gait speed	gait analysis	Baseline (hospital discharge)

Secondary Outcomes

Measure	Description	Time Frame
Functional Parameter: timed up & go (TUG) time	timed up & go (TUG) test	Baseline (hospital discharge)
Functional Parameter: stair climbing time	stair climbing test

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 60 years
Informed written consent
Existing or risk of malnutrition
Normal cognitive status according to Mini-Mental State Examination (MMSE ≥ 24 points)
Life expectancy of > 3 months according to treating doctor

Exclusion Criteria:

Age < 60 years
Lack of informed written consent
No risk of malnutrition
Low cognitive status according to Mini-Mental State Examination (MMSE < 24 points)
Life expectancy of < 3 months according to treating doctor

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Study participants are assessed upon discharge from the hospital. Only malnourished patients were analyzed.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kristina Norman, PD Dr.	Contact	+4930450565139		kristina.norman@charite.de
Kristina Franz, M.Sc.	Contact	+4930450565137		kristina.franz@charite.de

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charite University, Berlin, Germany	Recruiting	Berlin			Germany

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
D000073496	Frailty

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