Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04618250
Other study ID # NNF16OC0022038
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 6, 2020
Est. completion date September 30, 2021

Study information

Verified date April 2022
Source University of Copenhagen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

People with a severe mental illness (SMI) have an increased risk for premature mortality, predominantly due somatic health conditions. Evidence indicates that prevention and improved treatment of somatic conditions in patients with SMI could reduce this excess mortality. This paper reports a protocol designed to evaluate the feasibility and acceptability of a coordinated co-produced care programme (SOFIA model) in the general practice setting to reduce mortality and improve quality of life in patients with severe mental illness. The primary outcomes are description of study feasibility (recruitment and retention) and acceptability. The SOFIA trial is designed as cluster randomized controlled trial targeting general practices in two regions in Denmark. 12 practices will each recruit 15 community-dwelling patients aged 18 and older with severe mental illness (SMI). Practices will be randomized in a ratio 2:1 to deliver a coordinated care program or care-as-usual during a 6 month period. An online randomized algorithm is used to perform randomization. The coordinated care program comprises enhanced educational training of general practitioners and their clinical staff, and prolonged consultations focusing on individual needs and preferences of the patient with SMI. Assessments are administered at baseline, and at end of study period. If delivery of the intervention in the general practice setting proves feasible, a future definitive trial to determine the effectiveness of the intervention in reducing mortality and improving quality of life in patients with SMI can take place.


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date September 30, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Registered at a general practice situated in the Danish Capital Region or the Region of Zealand; - Registered at general practice with International Classification of Primary Care version 2 (ICPC-2) diagnostic code p72 (psychotic disorders); - Registered at general practice with ICPC-2 diagnostic code p73 (bipolar mood disorders); - Prescription of Lithium (Anatomical Therapeutic Chemical (ATC): N05AN); - Registered at general practice with ICPC-2 diagnostic code p76 AND (Prescription of Lamotrigine (N03A09) OR Carbamazepine (N03AF01) OR Valproic Acid (N03AG01)); - Registered at general practice with ICPC-2 diagnostic code p76 (unipolar depressive disorders) AND (Prescription of tricyclic antidepressants (N06AA) AND/OR venlafaxine (N06AX16) AND/OR duloxetine (N06AX21) AND/OR Monoamine Oxidase A Inhibitor (MAOi) (N06AG) AND/OR non-selective MAOi (N06AF)). Exclusion Criteria: - Subjected to any type of legal measure as stipulated in the Danish Mental Health Law; - Registered with a dementia diagnosis ICPC-2 p70 (dementia); - Receiving end-of-life care; - Non-Danish speakers; - Assumed by the patient's general practitioner to have an overall functional level that is too low for meaningful participation in trial.

Study Design


Intervention

Other:
SOFIA model
A mandatory two day course for general practitioners assigned to the intervention group A prolonged consultation at the general practitioner Use of an individual care plan

Locations

Country Name City State
Denmark University of Copenhagen Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effectiveness of the design in terms of recruitment of practices and patients Proportion of contacted general practices, which agree to participate in the study and the eligibility and consent rate of patients. 6 months after randomization
Primary Acceptability of the intervention for patients and general practitioners, staff and patients. Qualitative semi-structured interviews with patients and general practitioners, staff and patients. Entire study period (6 months)
Primary Retention of patients during the study Proportion of recruited patients in the intervention group who attend the first consultation. 6 months after randomization
Primary Acceptability of REDcap software for general practitioners Qualitative semi-structured interviews with general practitioners. Entire study period (6 months)
Primary Effectiveness of the collecting Multimorbidity Questionnaires Proportion of returned and completed Multimorbidity Questionnaires. 6 months after randomization
Primary Effectiveness of the collecting EQ5D-5L questionnaires Proportion of returned and completed EQ5D-5L questionnaire. 6 months after randomization
Primary Mortality Number of all-cause deaths of participants during the 6 month trial period. 6 months after randomization
Primary Hospitalizations Number of all-cause in- and outpatient hospitalizations of participants during the 6 months trial period. 6 months after randomization
Secondary Multimorbidity Questionnaires (MMQ) scores Scores on Multimorbidity Questionnaire 3 times during study period (at baseline, before prolonged consultation and 6 months after randomization
See also
  Status Clinical Trial Phase
Recruiting NCT05039489 - A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia N/A
Completed NCT05321602 - Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder Phase 1
Completed NCT05111548 - Brain Stimulation and Cognitive Training - Efficacy N/A
Completed NCT04503954 - Efficacy of Chronic Disease Self-management Program in People With Schizophrenia N/A
Completed NCT02831231 - Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium Phase 1
Completed NCT05517460 - The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center N/A
Completed NCT03652974 - Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy Phase 4
Recruiting NCT04012684 - rTMS on Mismatch Negativity of Schizophrenia N/A
Recruiting NCT04481217 - Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia N/A
Completed NCT00212784 - Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935) Phase 3
Completed NCT04092686 - A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia Phase 3
Completed NCT01914393 - Pediatric Open-Label Extension Study Phase 3
Recruiting NCT03790345 - Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics Phase 2/Phase 3
Recruiting NCT05956327 - Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training N/A
Terminated NCT03261817 - A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders N/A
Terminated NCT03209778 - Involuntary Memories Investigation in Schizophrenia N/A
Completed NCT02905604 - Magnetic Stimulation of the Brain in Schizophrenia or Depression N/A
Recruiting NCT05542212 - Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia N/A
Completed NCT04411979 - Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia N/A
Terminated NCT03220438 - TMS Enhancement of Visual Plasticity in Schizophrenia N/A