NCT03066232

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
211

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 28, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2018

Completed
Last Updated

August 22, 2018

Status Verified

August 1, 2018

Enrollment Period

3.2 years

First QC Date

February 20, 2017

Last Update Submit

August 21, 2018

Conditions

Delirium

Keywords

DeliriumDementiaPhysical function

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sandefjord kommune

Sandefjord, Norway

Location

Biospecimen

Retention: SAMPLES WITH DNA

EDTA blood samples serum

MeSH Terms

Conditions

DeliriumDementia

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System Diseases

Study Officials

  • Torgeir Bruun Wyller, MD, PhD

    Oslo University Hospital, University of Oslo

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 20, 2017

First Posted

February 28, 2017

Study Start

May 11, 2015

Primary Completion

July 8, 2018

Study Completion

July 8, 2018

Last Updated

August 22, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)