Improving Physical Health in Patients With Psychiatric Disorders in General Practice (SOFIA)

NCT ID: NCT04618250

Last Updated: 2022-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-06
• Study Completion Date: 2021-09-30

Brief 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.

Conditions

Psychiatric Disorder; Schizophrenia; Bipolar Disorder; Severe Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Coordinated, co-produced health care

Group Type: EXPERIMENTAL

SOFIA model

Intervention Type: OTHER

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

Care as usual

Care as usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Susanne Reventlow

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susanne Reventlow

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Locations

University of Copenhagen

Copenhagen, , Denmark

Countries

Denmark

References

Tranberg K, Due TD, Rozing M, Jonsson ABR, Kousgaard MB, Moller A. Challenges in reaching patients with severe mental illness for trials in general practice-a convergent mixed methods study based on the SOFIA pilot trial. Pilot Feasibility Stud. 2023 Oct 31;9(1):182. doi: 10.1186/s40814-023-01395-y.

Reference Type: DERIVED

PMID: 37908003 (View on PubMed)

Tranberg K, Jonsson A, Due T, Siersma V, Brodersen JB, Bissenbakker K, Martiny F, Davidsen A, Kjellberg PK, Doherty K, Mercer SW, Nielsen MH, Reventlow S, Moller A, Rozing M; SOFIA Study Group. The SOFIA pilot study: assessing feasibility and fidelity of coordinated care to reduce excess mortality and increase quality of life in patients with severe mental illness in a general practice setting; a cluster-randomised pilot trial. BMC Prim Care. 2023 Sep 16;24(1):188. doi: 10.1186/s12875-023-02141-2.

Reference Type: DERIVED

PMID: 37715123 (View on PubMed)

Rozing MP, Jonsson A, Koster-Rasmussen R, Due TD, Brodersen J, Bissenbakker KH, Siersma V, Mercer SW, Guassora AD, Kjellberg J, Kjellberg PK, Nielsen MH, Christensen I, Bardram JE, Martiny F, Moller A, Reventlow S; SOFIA Study Group. The SOFIA pilot trial: a cluster-randomized trial of coordinated, co-produced care to reduce mortality and improve quality of life in people with severe mental illness in the general practice setting. Pilot Feasibility Stud. 2021 Sep 3;7(1):168. doi: 10.1186/s40814-021-00906-z.

Reference Type: DERIVED

PMID: 34479646 (View on PubMed)

Other Identifiers

NNF16OC0022038

Identifier Type: -

Identifier Source: org_study_id