NCT03314350

Brief Summary

In geriatric patients, there is a plethora of nutritional and illness-related parameters, resulting in a complex situation which hampers identification of risk factors.In the planned prospective study, the point and period prevalence of wound healing disorders (WHD) is examined at admission and at discharge in a cohort of 517 male and female geriatric patients. As the investigators are also interested to study the occurrence of WHD in patients with malnutrition (and other geriatric phenomena) compared to the prevalence of WHD in patients with a good nutritional Status.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
517

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 19, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

November 13, 2019

Status Verified

November 1, 2019

Enrollment Period

2.2 years

First QC Date

October 16, 2017

Last Update Submit

November 11, 2019

Conditions

Keywords

GeriatricsFrailty

Outcome Measures

Primary Outcomes (1)

  • Prevalence of wound healing disturbances

    Number of wound healing disturbances upon admission to the hospital in General

    Baseline

Secondary Outcomes (9)

  • Nutritional Parameter

    Baseline and up to 3 weeks

  • Functional Parameter

    Baseline and up to 3 weeks

  • Functional Parameter

    Baseline and up to 3 weeks

  • Functional Parameter

    Baseline and up to 3 weeks

  • Strength Parameter

    Baseline and up to 3 weeks

  • +4 more secondary outcomes

Eligibility Criteria

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

Geriatric patients will be recruted upon admission to the hospital.

You may qualify if:

  • Age ≥ 60 years
  • Informed written consent
  • Normal cognitive status according to Mini-Mental State Examination (MMSE ≥ 24 points)
  • Life expectancy of \> 3 months according to treating doctor
  • Proficient in German

You may not qualify if:

  • Lack or incapacity of informed consent
  • MMSE \< 24
  • Life expectancy \< 3 months according to assessment by the attending physician
  • Short term patients (\< 3 days of hospital stay)
  • Lack of German language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite University Medicine, Research Group on Geriatrics

Berlin, 13347, Germany

RECRUITING

Related Publications (1)

  • Shahin ES, Meijers JM, Schols JM, Tannen A, Halfens RJ, Dassen T. The relationship between malnutrition parameters and pressure ulcers in hospitals and nursing homes. Nutrition. 2010 Sep;26(9):886-9. doi: 10.1016/j.nut.2010.01.016. Epub 2010 May 4.

    PMID: 20444575BACKGROUND

MeSH Terms

Conditions

MalnutritionFrailty

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kristina Norman, PD Dr.

    Charite Research Group on Geriatrics

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristina Norman, PD Dr.

CONTACT

Kristina Franz, MScIS

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. Kristina Norman

Study Record Dates

First Submitted

October 16, 2017

First Posted

October 19, 2017

Study Start

November 1, 2017

Primary Completion

January 31, 2020

Study Completion

January 31, 2021

Last Updated

November 13, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations