Quality Register for Geriatric Psychiatry | NCT01415310

Studies
Quality Register for Geriatric Psychiatry

NCT01415310

Sponsor

Geir Selbaek

Status

Recruiting

Last Update Posted

Jul 8, 2022Actual

Enrollment

19,000Estimated

Phase

Not provided

Conditions

Geriatric Disorder
Depression

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

Jul 2022

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2011

Primary Completion Date

Dec 2030Estimated

Completion Date

Dec 2030Estimated

First Submitted Date

Aug 10, 2011

First Submission Date that Met QC Criteria

Aug 10, 2011

First Posted Date

Aug 11, 2011Estimated

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 7, 2022

Last Update Posted Date

Jul 8, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Geir Selbaek, Director of research, Norwegian Centre for Ageing and HealthSponsor-Investigator

Lead Sponsor

Geir SelbaekOTHER

Collaborators

Name	Class
Oslo University Hospital	OTHER
University Hospital, Akershus	OTHER
Diakonhjemmet Hospital	OTHER

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

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

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

19,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Geriatric psychiatry		Elderly patients with psychiatric disorders in geriatric psychiatry units

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Depression and cognition	Scores on assessment scales (MADRS, Cornell scale, MMSE)	During admission

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients submitted to geriatric psychiatry units and their relatives who sign the consent form

Exclusion Criteria:

Patients and relatives who refuse to sign the consent form

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

Patients submitted to the geriatric psychiatry units in the Viken Research network for Geriatric Psychiatry

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lisbeth D Høgset, MSc	Contact	97582098	0047	Lisebeth.Dyrendal.Hogset@sykehuset-innlandet.no
Kari M Kristiansen, MSc	Contact	97761638	0047	kari.kristiansen@aldringoghelse.no

Overall Officials

Name	Affiliation	Role
Knut A. Engedal, professor	Norwegian Centre for Ageing and Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Old Age Psychiatry Unit, Diakonhjemmet Hospital	Recruiting	Oslo		0854	Norway

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided