Norwegian Adult Mental Health Registry

NCT06115200 | Not Yet Recruiting

• 1 other identifier: NAMHR001
• Study Type: observational
• Target: 150,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

"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.

Conditions

Depression; Schizophrenia; Bipolar Disorder; Eating Disorders; Anxiety Disorders; Ptsd; Personality Disorders; Adhd

Keywords

database; epidemiology; mental health register

Outcome Measures

Primary Outcomes (16)

• Patient Reported Outcome Measures (PROMs)

  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)

  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)

  Percentage of subjects that experienced change in PROMs

  Six months after discharge

• Drug name and dosage from electronic medication management solutions

  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

  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

  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)

  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)

  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)

  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)

  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

  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

  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

  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

  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

  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

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Helse Stavanger HF: lead

MeSH Terms

Conditions

Depression; Schizophrenia; Bipolar Disorder; Feeding and Eating Disorders; Anxiety Disorders; Stress Disorders, Post-Traumatic; Personality Disorders; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders

Study Officials

• Inge Joa, PhD

  Stavanger University hospital, Stavanger, Norway

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Inge Joa, PhD

CONTACT

+4791392373; inge.joa@sus.no

Tore Tjora, PhD

CONTACT

tore.tjora@sus.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Months
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: November 2, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: November 2, 2023

Record last verified: 2023-05