NAMHR: Norwegian Adult Mental Health Registry

Sponsor
Helse Stavanger HF (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06115200
Collaborator
(none)
150,000
84

Study Details

Study Description

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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
150000 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Norwegian Adult Mental Health Registry
Anticipated Study Start Date :
Jan 1, 2024
Anticipated Primary Completion Date :
Dec 31, 2030
Anticipated Study Completion Date :
Dec 31, 2030

Outcome Measures

Primary Outcome Measures

  1. Patient Reported Outcome Measures (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]

    Percentage of subjects that experienced change in PROMs

  2. Patient Reported Outcome Measures (PROMs) [Discharge defined as: date of discharge from any cause, assessed up to 60 months]

    Percentage of subjects that experienced change in PROMs

  3. Patient Reported Outcome Measures (PROMs) [Six months after discharge]

    Percentage of subjects that experienced change in PROMs

  4. Drug name and dosage from electronic medication management solutions [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

  5. Drug name and dosage from electronic medication management solutions [Discharge defined as: date of discharge from any cause, assessed up to 60 months]

    Frequency of psychotropic generic drug name and dosage

  6. Drug name and dosage from electronic medication management solutions [Six months after discharge from any cause, assessed up to 12 months]

    Frequency of psychotropic generic drug name and dosage

  7. Rate of overweight defined as BMI > 25 (body mass index) [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.

  8. Rate of overweight defined as BMI > 25 (body mass index) [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.

  9. Level of glycated haemoglobin (HbA1c) [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.

  10. Level of glycated haemoglobin (HbA1c) [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.

  11. Level of blood pressure, both systolic and diastolic levels [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.

  12. Level of blood pressure, both systolic and diastolic levels [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.

  13. Bloodlevels of 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]

    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.

  14. Bloodlevels of total cholesterol, LDL, HDL and Triglycerides [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.

  15. Frequency of ICD-10 or ICD-11 diagnosis 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]

    International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10) or ISD-11: Chapter V: Mental and behavioural disorders (F00-F99)

  16. Frequency of ICD-10 or ICD-11 diagnosis F00-F99 [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Helse Stavanger HF

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Helse Stavanger HF
ClinicalTrials.gov Identifier:
NCT06115200
Other Study ID Numbers:
  • NAMHR001
First Posted:
Nov 2, 2023
Last Update Posted:
Nov 2, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Helse Stavanger HF
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 2, 2023