Norwegian Adult Mental Health Registry (NAMHR)

November 1, 2023 updated by: Helse Stavanger HF
"The Norwegian Adult Mental Health Registry" (NAMHR) is a medical quality register collecting and systematizing data on patients and their treatment in specialist mental health care for adults in Norway. The main purpose is to create a documentation basis for quality assurance, evaluation, and improvement of assessment and treatment for patients who are offered treatment for mental disorders in the specialist health service. The register uses automatic data capture from various existing data sources. New patients are automatically included, but given the opportunity for reservations from the register without affecting their services and treatment.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

150000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Residents in Norway aged 18 years or older and granted right to treatment in mental specialized in- and out-patient settings (approximately 150.000 participants)

Description

Inclusion Criteria:

  • Residents in Norway aged 18 years or older assessed and granted right to treatment in specialized mental in- and out-patient settings

Exclusion Criteria:

  • Persons who have reserved themselves against participation
  • Persons already included in more specialized register for mental disorder and/or treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Reported Outcome Measures (PROMs)
Time Frame: Baseline defined as: From start of treatment date (inclusion in the register) until the date of first documented assessment or date of discharge from any cause, whichever came first, assessed up to 24 months
Percentage of subjects that experienced change in PROMs
Baseline defined as: From start of treatment date (inclusion in the register) until the date of first documented assessment or date of discharge from any cause, whichever came first, assessed up to 24 months
Patient Reported Outcome Measures (PROMs)
Time Frame: Discharge defined as: date of discharge from any cause, assessed up to 60 months
Percentage of subjects that experienced change in PROMs
Discharge defined as: date of discharge from any cause, assessed up to 60 months
Patient Reported Outcome Measures (PROMs)
Time Frame: Six months after discharge
Percentage of subjects that experienced change in PROMs
Six months after discharge
Drug name and dosage from electronic medication management solutions
Time Frame: Baseline defined as: From start of treatment date (inclusion in the register) until the date of first documented assessment or date of discharge from any cause, whichever came first, assessed up to 24 months
Frequency of psychotropic generic drug name and dosage
Baseline defined as: From start of treatment date (inclusion in the register) until the date of first documented assessment or date of discharge from any cause, whichever came first, assessed up to 24 months
Drug name and dosage from electronic medication management solutions
Time Frame: Discharge defined as: date of discharge from any cause, assessed up to 60 months
Frequency of psychotropic generic drug name and dosage
Discharge defined as: date of discharge from any cause, assessed up to 60 months
Drug name and dosage from electronic medication management solutions
Time Frame: Six months after discharge from any cause, assessed up to 12 months
Frequency of psychotropic generic drug name and dosage
Six months after discharge from any cause, assessed up to 12 months
Rate of overweight defined as BMI > 25 (body mass index)
Time Frame: Baseline defined as: From start of treatment date (inclusion in the register) until the date of first documented assessment or date of discharge from any cause, whichever came first, assessed up to 24 months
Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters.
Baseline defined as: From start of treatment date (inclusion in the register) until the date of first documented assessment or date of discharge from any cause, whichever came first, assessed up to 24 months
Rate of overweight defined as BMI > 25 (body mass index)
Time Frame: Discharge defined as: date of discharge from any cause, assessed up to 60 months
Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters.
Discharge defined as: date of discharge from any cause, assessed up to 60 months
Level of glycated haemoglobin (HbA1c)
Time Frame: Baseline defined as: From start of treatment date (inclusion in the register) until the date of first documented assessment or date of discharge from any cause, whichever came first, assessed up to 24 months
Glycated hemoglobin is a form of hemoglobin chemically linked to sugar.
Baseline defined as: From start of treatment date (inclusion in the register) until the date of first documented assessment or date of discharge from any cause, whichever came first, assessed up to 24 months
Level of glycated haemoglobin (HbA1c)
Time Frame: Discharge defined as: date of discharge from any cause, assessed up to 60 months
Glycated hemoglobin is a form of hemoglobin chemically linked to sugar.
Discharge defined as: date of discharge from any cause, assessed up to 60 months
Level of blood pressure, both systolic and diastolic levels
Time Frame: Baseline defined as: From start of treatment date (inclusion in the register) until the date of first documented assessment or date of discharge from any cause, whichever came first, assessed up to 24 months
Blood pressure varies between systolic and diastolic pressures after each heartbeat. Systolic pressure is peak (maximum) pressure in the arteries. Diastolic pressure is the lowest (minimum) pressure in the arteries.
Baseline defined as: From start of treatment date (inclusion in the register) until the date of first documented assessment or date of discharge from any cause, whichever came first, assessed up to 24 months
Level of blood pressure, both systolic and diastolic levels
Time Frame: Discharge defined as: date of discharge from any cause, assessed up to 60 months
Blood pressure varies between systolic and diastolic pressures after each heartbeat. Systolic pressure is peak (maximum) pressure in the arteries. Diastolic pressure is the lowest (minimum) pressure in the arteries.
Discharge defined as: date of discharge from any cause, assessed up to 60 months
Bloodlevels of total cholesterol, LDL, HDL and Triglycerides
Time Frame: Baseline defined as: From start of treatment date (inclusion in the register) until the date of first documented assessment or date of discharge from any cause, whichever came first, assessed up to 24 months
A lipid profile (lipid panel) is a set blood tests used to find abnormalities in blood lipids. The present panel will include: total cholesterol, LDL, HDL and Triglycerides.
Baseline defined as: From start of treatment date (inclusion in the register) until the date of first documented assessment or date of discharge from any cause, whichever came first, assessed up to 24 months
Bloodlevels of total cholesterol, LDL, HDL and Triglycerides
Time Frame: Discharge defined as: date of discharge from any cause, assessed up to 60 months
A lipid profile (lipid panel) is a set blood tests used to find abnormalities in blood lipids. The present panel will include: total cholesterol, LDL, HDL and Triglycerides.
Discharge defined as: date of discharge from any cause, assessed up to 60 months
Frequency of ICD-10 or ICD-11 diagnosis F00-F99
Time Frame: Baseline defined as: From start of treatment date (inclusion in the register) until the date of first documented assessment or date of discharge from any cause, whichever came first, assessed up to 24 months
International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10) or ISD-11: Chapter V: Mental and behavioural disorders (F00-F99)
Baseline defined as: From start of treatment date (inclusion in the register) until the date of first documented assessment or date of discharge from any cause, whichever came first, assessed up to 24 months
Frequency of ICD-10 or ICD-11 diagnosis F00-F99
Time Frame: Discharge defined as: date of discharge from any cause, assessed up to 60 months
International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10) or ISD-11: Chapter V: Mental and behavioural disorders (F00-F99)Revision (ICD-10) WHO: Chapter V: Mental and behavioural disorders (F00-F99)
Discharge defined as: date of discharge from any cause, assessed up to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helse Stavanger HF

Investigators

  • Principal Investigator: Inge Joa, PhD, Stavanger University hospital, Stavanger, Norway

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

July 3, 2023

First Submitted That Met QC Criteria

November 1, 2023

First Posted (Actual)

November 2, 2023

Study Record Updates

Last Update Posted (Actual)

November 2, 2023

Last Update Submitted That Met QC Criteria

November 1, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAMHR001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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