SIB-Norwegian Version, Validation and Reliability Study | NCT00449384

Studies
SIB-Norwegian Version, Validation and Reliability Study

NCT00449384

Sponsor

Sykehuset Innlandet HF

Status

Completed

Last Update Posted

Jul 3, 2007Estimated

Enrollment

59Actual

Phase

Not provided

Conditions

Dementia
Diagnostic Tests, Routine

Interventions

Diagnostic Screening

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

Jul 2007

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

Feb 2007

Primary Completion Date

Not provided

Completion Date

May 2007Actual

First Submitted Date

Mar 19, 2007

First Submission Date that Met QC Criteria

Mar 19, 2007

First Posted Date

Mar 20, 2007Estimated

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

Jul 2, 2007

Last Update Posted Date

Jul 3, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose of this study is to validate and to test interrater reliability for the Norwgian version of Severe Impairment Battery (SIB).

Detailed Description

The study will include 60 persons with mild to severe dementia. To test the validation of SIB, we will interview the included persons with Severe Impairment Battery (SIB) and compare the results with Clinical Dementia Rating (CDV)reported by their nurses. To test interrater reliability 30 of the included persons will be interviewed with SIB by two different raters, and the two raters results will be compared.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

59Actual

Name	Type	Description	Arm Group Labels	Other Names
Diagnostic Screening	Behavioral

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Dementia, mild to severe.
Nursing Home resident

Exclusion Criteria:

No ability to write or read.
Physical handicapped, unable to use hands.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Knut Engedal, PhD	The Norwegian Centre for Dementia Research (NCDR), Norway	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sykehuset Innlandet HF - Sanderud		Ottestad	Oppland	2312	Norway

Condition Browse Module

MeSH Terms

ID	Term
D003704	Dementia

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D019965	Neurocognitive Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000076862	Diagnostic Screening Programs

Ancestor Terms

ID	Term
D003954	Diagnostic Services
D011314	Preventive Health Services
D006296	Health Services
D005159	Health Care Facilities Workforce and Services

Browse Leaves

Not provided

Browse Branches

Not provided