NCT06807242

Brief Summary

Observational study of the implementation of a Norwegian adaptation of a tool for monitoring, detection and intervention of cardiovascular risk factors in severe mental disorders. The project investigates if the medical care is improved or the cardiovascular risk is reduced after implementation. Patients and service provision/clinical interventions is assessed at baseline and at 12 months, with a historic patient comparison group with the same assessments except for service provision/clinical interventions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 4, 2025

Completed
Last Updated

February 4, 2025

Status Verified

April 1, 2019

Enrollment Period

2.2 years

First QC Date

January 29, 2025

Last Update Submit

January 29, 2025

Conditions

Schizophrenic PsychosesSchizophreniaSevere Mental Disorder

Outcome Measures

Primary Outcomes (9)

  • BMI

    kg/m2

    t=0 and t=12months

  • HbA1c

    Glucosylated hemoglobine

    t=0 and t=12months

  • Blood lipids

    Tot-Cholesterol, HDL-Chol. LDL-Chol, Triglycerides

    t=0 and t=12months

  • Blood pressure

    Systolic and diastolic blood pressure

    t=0 and t=12months

  • Smoking status

    Smoking tobacco daily

    t=0 and t=12months

  • Waist circumference

    in cm

    t=0 and t=12months

  • Physical Activity level

    Self report of hours in Activity or sedentary behavior or Level of intensity

    t=0 and t=12months

  • Diet

    unhealthy diet,self report

    t=0 and t=12months

  • NORRISK

    Composite score of cardiovascular risk

    t=0 and t=12months

Secondary Outcomes (2)

  • Level of Medical care

    t=0 (baseline) and t=12months

  • Interventions for cardiovascular risk reduction

    t=0 (baseline) and t=12months

Study Arms (2)

Intervention group

Clinical characteristics and Level of Medical care in patients receiving the intervention. Assessments at baseline and at 12 months. Inclusion criteria: Over 18 years. Use of antipsychotic or a diagnosis of schizophrenia Spectrum or bipolar disorder Spectrum. Intervention: Implementation of the Norwegian adaptation of a tool for reduction of cardiovascular risk in severe mental disorders

Control group

Clinical characteristics in patients not receiving the intervention. Historic cohort with asessments at t=0 and at 12 months. Inclusion criteria: Over 18 years. Use of antipsychotic or a diagnosis of schizophrenia Spectrum or bipolar disorder Spectrum.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Severe mental disorder or use of antipsychotics

You may qualify if:

  • Age 18+. Diagnosis of ICD10 F2 or F3 and/or use of antipsychotics

You may not qualify if:

  • inability to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, 0450, Norway

Location

Related Publications (1)

  • Lund-Stenvold EH, Ringen PA, Andreassen OA, Gaarden TL, Hartberg CB, Johnsen E, Myklatun S, Osnes K, Sorensen K, Vaaler A, Tonstad S, Engh JA, Hoye A. Implementation of the healthy heart tool- an algorithm with potential cardiometabolic health benefits in persons with severe mental illness. BMC Psychiatry. 2025 Feb 25;25(1):172. doi: 10.1186/s12888-025-06578-w.

    PMID: 40001014DERIVED

MeSH Terms

Conditions

SchizophreniaMental Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Avdelingsoverlege

Study Record Dates

First Submitted

January 29, 2025

First Posted

February 4, 2025

Study Start

January 1, 2017

Primary Completion

March 1, 2019

Study Completion

December 1, 2019

Last Updated

February 4, 2025

Record last verified: 2019-04

Locations

NO(1)