Geriatric DisorderKVALAPNCT01415310
Quality Register for Geriatric Psychiatry
An observational study of Geriatric Disorder and Depression, run by Geir Selbaek at 1 site in Norway.
Trial summary
QualGeP (KVALAP) is a quality register in Viken Research network for Geriatric Psychiatry. The objectives of the register are to enhance our knowledge of old persons with severe psychiatric disorders, and to secure an optimal medical evaluation, treatment and care for these patients. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Geriatric Disorder, Depression
- How many people
- 19,000 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2011to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients submitted to the geriatric psychiatry units in the Viken Research network for Geriatric Psychiatry
Who may be able to join
- Patients submitted to geriatric psychiatry units and their relatives who sign the consent form
Who cannot join
- Patients and relatives who refuse to sign the consent form
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Old Age Psychiatry Unit, Diakonhjemmet Hospital
Oslo, 0854
Kari M Kristiansen, MSc, 97761638 ext. 0047, kari.kristiansen@diakonsyk.no
Ronny Nielsen, RN, 91625232 ext. 0047, ronny.nielsen@diakonsyk.no
About this study
Official title: Quality Register for Geriatric Psychiatry in Viken Research Network for Geriatric Psychiatry
QualGeP (KVALAP) is a quality register in Viken Research network for Geriatric Psychiatry. The objectives of the register are to enhance our knowledge of old persons with severe psychiatric disorders, and to secure an optimal medical evaluation, treatment and care for these patients. The data in the register will be used for quality assurance and for research.
Aims:
- Quality assurance
- Further development of our diagnostic and screening tools
- Contributing to improving the treatment, with and without drugs
- Contributing to improving the dialogue and collaboration between primary healthcare and hospitals
Read the detailed description
Data collected:
- Demographic data
- Previous and present disorders and use of drugs
- Data from relatives regarding:
- the patient's cognition
- psychiatric health
- behaviour
- activities of daily living
- the stress and care burden of relatives
- Tests of cognitive functions
- Methods and duration for treatment
- Transfer to primary healthcare
- Possible readmissions
- Conditions
- Geriatric Disorder, Depression
- Keywords
- Geriatric Psychiatry, Quality register, Quality improvement, Quality control, Research elderly patients with psychiatric disorders
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Geriatric psychiatry | Elderly patients with psychiatric disorders in geriatric psychiatry units |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression and cognition
Scores on assessment scales (MADRS, Cornell scale, MMSE)
Measured: During admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geriatric DisorderStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Geir Selbaek
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital, University Hospital, Akershus, Diakonhjemmet Hospital
- Responsible party
- Sponsor-investigator, Geir Selbaek, Norwegian Centre for Ageing and Health
- Investigators
- Knut A. Engedal, professor, Principal investigator, Norwegian Centre for Ageing and Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01415310
- Sponsor's protocol ID
- KVALAP (QualGeP)
- Acronym
- KVALAP
- Status last verified
- Jul 2022
- First submitted
- 10 Aug 2011
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Register for Geriatric Psychiatry in Viken Research Network for Geriatric Psychiatry
- ClinicalTrials.gov ID
- NCT01415310
- Acronym / sponsor ID
- KVALAP / KVALAP (QualGeP)
- Conditions
- Geriatric Disorder, Depression
- Keywords
- Geriatric Psychiatry, Quality register, Quality improvement, Quality control, Research elderly patients with psychiatric disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 19,000 participants (estimated)
- Lead sponsor
- Geir SelbaekUniversity, hospital or other
- Collaborators
- Oslo University Hospital, University Hospital, Akershus, Diakonhjemmet Hospital
- Study start
- Apr 2011
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 11 Aug 2011 (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.
QualGeP (KVALAP) is a quality register in Viken Research network for Geriatric Psychiatry. The objectives of the register are to enhance our knowledge of old persons with severe psychiatric disorders, and to secure an optimal medical evaluation, treatment and care for these patients. The data in the register will be used for quality assurance and for research.
Aims:
- Quality assurance
- Further development of our diagnostic and screening tools
- Contributing to improving the treatment, with and without drugs
- Contributing to improving the dialogue and collaboration between primary healthcare and hospitals
Detailed description
Data collected:
- Demographic data
- Previous and present disorders and use of drugs
- Data from relatives regarding:
- the patient's cognition
- psychiatric health
- behaviour
- activities of daily living
- the stress and care burden of relatives
- Tests of cognitive functions
- Methods and duration for treatment
- Transfer to primary healthcare
- Possible readmissions
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Geriatric psychiatry | – | –Elderly patients with psychiatric disorders in geriatric psychiatry units |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients submitted to the geriatric psychiatry units in the Viken Research network for Geriatric Psychiatry
Key inclusion criteria (1 listed)
- Patients submitted to geriatric psychiatry units and their relatives who sign the consent form
Key exclusion criteria (1 listed)
- Patients and relatives who refuse to sign the consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Depression and cognition
Time frame: During admission
Scores on assessment scales (MADRS, Cornell scale, MMSE)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
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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.
Knut A. Engedal, professor principal investigator
Norwegian Centre for Ageing and Health
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 Geriatric Disorder and Depression, run by Geir Selbaek 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 8 Jul 2022. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisbeth D Høgset, MSc (97582098 ext. 0047, Lisebeth.Dyrendal.Hogset@sykehuset-innlandet.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression and cognition (time frame: During admission). It is what the study was designed to measure, not a finding.
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 8 Jul 2022.