DementiaNCT00449384
SIB-Norwegian Version, Validation and Reliability Study
An observational study of Dementia and Diagnostic Tests, Routine, run by Sykehuset Innlandet HF at 1 site in Norway.
Trial summary
The purpose of this study is to validate and to test interrater reliability for the Norwgian version of Severe Impairment Battery (SIB). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia, Diagnostic Tests, Routine
- What is being tested?
- Diagnostic Screening
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 59 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2007to May 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Dementia, mild to severe.
- Nursing Home resident
Who cannot join
- No ability to write or read.
- Physical handicapped, unable to use hands.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Severe Impairment Study - Norwegian Version. A Validation and Reliability Study.
The purpose of this study is to validate and to test interrater reliability for the Norwgian version of Severe Impairment Battery (SIB).
Read the 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.
- Conditions
- Dementia, Diagnostic Tests, Routine
- Being tested
- Diagnostic Screening
- Keywords
- Severe Impairment Battery, Clinical Dementia Rating
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic ScreeningBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2007 (estimated)
- Study startFeb 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset Innlandet HF
- Sponsor type
- University, hospital or other
- Investigators
- Knut Engedal, PhD, Study chair, The Norwegian Centre for Dementia Research (NCDR), Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00449384
- Sponsor's protocol ID
- F06002
- Status last verified
- Jul 2007
- First submitted
- 19 Mar 2007
- Last updated
- 3 Jul 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Severe Impairment Study - Norwegian Version. A Validation and Reliability Study.
- ClinicalTrials.gov ID
- NCT00449384
- Acronym / sponsor ID
- F06002
- Conditions
- Dementia, Diagnostic Tests, Routine
- Keywords
- Severe Impairment Battery, Clinical Dementia Rating
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Sykehuset Innlandet HFUniversity, hospital or other
- Study start
- Feb 2007
- Study completion
- May 2007 (actual)
- First posted
- 20 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Dementia, mild to severe.
- Nursing Home resident
Key exclusion criteria (2 listed)
- No ability to write or read.
- Physical handicapped, unable to use hands.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic Screening | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Knut Engedal, PhD study chair
The Norwegian Centre for Dementia Research (NCDR), Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia and Diagnostic Tests, Routine, run by Sykehuset Innlandet HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2007.