Delirium in Home-dwelling Old People Receiving Home Nursi... | NCT03066232

Studies
Delirium in Home-dwelling Old People Receiving Home Nursing Care

NCT03066232

Sponsor

Oslo University Hospital

Status

Completed

Last Update Posted

Aug 22, 2018Actual

Enrollment

211Actual

Phase

Not provided

Conditions

Delirium

Interventions

Not provided

Countries

Norway

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

Aug 2018

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

May 11, 2015Actual

Primary Completion Date

Jul 8, 2018Actual

Completion Date

Jul 8, 2018Actual

First Submitted Date

Feb 20, 2017

First Submission Date that Met QC Criteria

Feb 22, 2017

First Posted Date

Feb 28, 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

Aug 21, 2018

Last Update Posted Date

Aug 22, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Maria Krogseth, MD, PhD, Oslo University HospitalPrincipal Investigator

Lead Sponsor

Oslo University HospitalOTHER

Collaborators

Name	Class
Sandefjord kommune	UNKNOWN
Norwegian Centre for Ageing and Health	OTHER
The Hospital of Vestfold	OTHER

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

Study the prevalence of delirium among old persons with home-nursing care living in the community. By recruiting the persons in a stable phase, the investigators wish to study the influence of an episode of delirium upon further cognitive and physical function.

Detailed Description

Not provided

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

Retention

Enrollment

211Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Trajectory of cognitive function using the MoCa test	The impact of an episode of delirium upon cognitive function measured by the Montreal Cognitive Assessment every 6th months for two years.	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Home nursing service at least once a week.
Home dwelling (not permanently institutionalised)
Age 65 years or more
Informed consent by the patient or a close relative (if the patient is unable to give a valid informed consent)

Exclusion Criteria:

Patient or relative denies inclusion
Terminal illness
Patients diagnosed with dementia with Lewy bodies (its fluctuating course makes the diagnosis of delirium challenging)
Patients with chronic diseases that have needed assistance from the home nursing service before the age of 65.
Assistance from the home nursing service is due to addictive substances.
Assistance from the home nursing service is due to psychiatric illnesses other than dementia.

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

Persons older than 65 years living in their own home receiving home nursing care at least once a week.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Torgeir Bruun Wyller, MD, PhD	Oslo University Hospital, University of Oslo	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sandefjord kommune		Sandefjord			Norway

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
D003693	Delirium
D003704	Dementia

Ancestor Terms

ID	Term
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided