Evaluation of Cognitive Impairment in the Elderly Admitte... | NCT05404152

Studies
Evaluation of Cognitive Impairment in the Elderly Admitted to Nursing Homes

NCT05404152

Sponsor

Universidad de Murcia

Status

Completed

Last Update Posted

Jul 5, 2022Actual

Enrollment

390Actual

Phase

Not provided

Conditions

Neurocognitive Disorder, Etiology of Neurocognitive Disorder

Interventions

Not provided

Countries

Spain

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

May 2022

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

Dec 31, 2021Actual

Primary Completion Date

Apr 1, 2022Actual

Completion Date

May 1, 2022Actual

First Submitted Date

May 30, 2022

First Submission Date that Met QC Criteria

May 30, 2022

First Posted Date

Jun 3, 2022Actual

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

Jun 29, 2022

Last Update Posted Date

Jul 5, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

This research aims at analysing the profile of the elderly with cognitive impairment (IC) and inquiring about the mental illnesses that cause cognitive impairment of a population (elderly admitted to nursing homes with a high incidence).

Detailed Description

The objectives of these studies are to determine the presence of IC and the profile of users who suffer from it in 8 nursing homes in the province of Pontevedra of new admission in 2017, as well as the identification of the frequency of underdiagnosis in the filiation of the mental pathology that causes IC and if that underdiagnosis is related to the presence of doctors or nurses specialists in geriatrics. Sociodemographic, clinical (with special relevance in cognitive assessment and the presence of mental disorders) and functional variables will be analyzed. In addition to providing information that can improve the DC early detection as well as the scarcity of studies in this field, the importance of this research is justified by developing treatment guidelines for people with IC in the future

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

390Actual

Label	Type	Description	Intervention Names
Ederly		Elderly Admitted to Nursing homes

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Study of Evaluation of Cognitive Impairment. MEC o MMSE <24 points or diagnosis of Neurocognitive disorder		Two years

Secondary Outcomes

Measure	Description	Time Frame
Statistical correlation of CI with educational level.		Two years

Other Outcomes

Measure	Description	Time Frame
Causes underdiagnosis of IC affiliation and Mental illnesses that cause IC		Two years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Vounteer
Elderly Admitted to Nursing homes
From 60 years old

Exclusion Criteria:

Elderly without cognitive assessment at admission
Existence of doubts about the presence of IC

Accepts Healthy Volunteers

Not provided

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

Elderly without cognitive assessment at admission
Existence of doubts about the presence of IC

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
MARIA ELENA MOSQUERA LOSADA, MSc in Nursing	Universidad de Murcia	Principal Investigator
ANTONIA GOMEZ-CONESA, PhD, PT	Universidad de Murcia	Study Director
RAMON GONZALEZ CABANACH, PhD	Universidade da Coruña	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UMurcia		Murcia			Spain

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D019965	Neurocognitive Disorders
D060825	Cognitive Dysfunction

Ancestor Terms

ID	Term
D001523	Mental Disorders
D003072	Cognition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided