Psychiatric DisorderSOFIANCT04618250
Improving Physical Health in Patients With Psychiatric Disorders in General Practice (SOFIA)
A study testing SOFIA model in people with Psychiatric Disorder and Schizophrenia, run by University of Copenhagen at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychiatric Disorder, Schizophrenia, Bipolar Disorder
- What is being tested?
- SOFIA model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteDenmark
- Study dates
- 6 Nov 2020to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cluster Randomized, Pilot Trial of Coordinated, Co-produced Care to Reduce Excess Mortality and Improve Quality of Life in Patients With Severe Mental Illness in General Practice Setting
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.
- Being tested
- SOFIA model
- Medical subject headings
- Mental Disorders, Schizophrenia, Bipolar Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOFIA modelOther
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
| Study group | Role | What they receive |
|---|---|---|
| Coordinated, co-produced health care | Experimental | Not described Receives: Other: SOFIA model |
| Care as usual | No intervention | Care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after randomization
Acceptability of the intervention for patients and general practitioners, staff and patients.
Qualitative semi-structured interviews with patients and general practitioners, staff and patients.
Measured: Entire study period (6 months)
Retention of patients during the study
Proportion of recruited patients in the intervention group who attend the first consultation.
Measured: 6 months after randomization
Acceptability of REDcap software for general practitioners
Qualitative semi-structured interviews with general practitioners.
Measured: Entire study period (6 months)
Effectiveness of the collecting Multimorbidity Questionnaires
Proportion of returned and completed Multimorbidity Questionnaires.
Measured: 6 months after randomization
Effectiveness of the collecting EQ5D-5L questionnaires
Proportion of returned and completed EQ5D-5L questionnaire.
Measured: 6 months after randomization
Mortality
Number of all-cause deaths of participants during the 6 month trial period.
Measured: 6 months after randomization
Hospitalizations
Number of all-cause in- and outpatient hospitalizations of participants during the 6 months trial period.
Measured: 6 months after randomization
Secondary outcomes (1)
Multimorbidity Questionnaires (MMQ) scores
Scores on Multimorbidity Questionnaire
Measured: 3 times during study period (at baseline, before prolonged consultation and 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start6 Nov 2020
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Psychiatric DisorderStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susanne Reventlow, University of Copenhagen
- Investigators
- Susanne Reventlow, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618250
- Sponsor's protocol ID
- NNF16OC0022038
- Acronym
- SOFIA
- Status last verified
- Apr 2022
- First submitted
- 26 Oct 2020
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants' study information will not be released outside of the study without the written permission of the participant.
Publications
Bjoern-Rozing M, Siersma V, Bissenbakker K, Nielsen MH, Jonsson ABR, Moller A, Brodersen JB. Quality-of-life and self-perceived inequity in people with severe mental illness: the SOFIA pilot study. Scand J Prim Health Care. 2026 Dec;44(1):2697923. doi: 10.1080/02813432.2026.2697923. Epub 2026 Aug 11.
PubMed 42578377Tranberg 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.
PubMed 37908003Tranberg 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.
PubMed 37715123Rozing 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.
PubMed 34479646
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomized, Pilot Trial of Coordinated, Co-produced Care to Reduce Excess Mortality and Improve Quality of Life in Patients With Severe Mental Illness in General Practice Setting
- ClinicalTrials.gov ID
- NCT04618250
- Acronym / sponsor ID
- SOFIA / NNF16OC0022038
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 6 Nov 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 5 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coordinated, co-produced health care | Experimental | Other: SOFIA model |
| Care as usual | No intervention | –Care as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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));
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOFIA modelA 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 | Other | Coordinated, co-produced health care |
Primary outcome
Effectiveness of the design in terms of recruitment of practices and patients
Time frame: 6 months after randomization
Proportion of contacted general practices, which agree to participate in the study and the eligibility and consent rate of patients.
Acceptability of the intervention for patients and general practitioners, staff and patients.
Time frame: Entire study period (6 months)
Qualitative semi-structured interviews with patients and general practitioners, staff and patients.
Retention of patients during the study
Time frame: 6 months after randomization
Proportion of recruited patients in the intervention group who attend the first consultation.
Acceptability of REDcap software for general practitioners
Time frame: Entire study period (6 months)
Qualitative semi-structured interviews with general practitioners.
Effectiveness of the collecting Multimorbidity Questionnaires
Time frame: 6 months after randomization
Proportion of returned and completed Multimorbidity Questionnaires.
Effectiveness of the collecting EQ5D-5L questionnaires
Time frame: 6 months after randomization
Proportion of returned and completed EQ5D-5L questionnaire.
Mortality
Time frame: 6 months after randomization
Number of all-cause deaths of participants during the 6 month trial period.
Hospitalizations
Time frame: 6 months after randomization
Number of all-cause in- and outpatient hospitalizations of participants during the 6 months trial period.
1 secondary outcome
Multimorbidity Questionnaires (MMQ) scores
Time frame: 3 times during study period (at baseline, before prolonged consultation and 6 months after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Derived from this study: PubMed 42578377Bjoern-Rozing M, Siersma V, Bissenbakker K, Nielsen MH, Jonsson ABR, Moller A, Brodersen JB. Quality-of-life and self-perceived inequity in people with severe mental illness: the SOFIA pilot study. Scand J Prim Health Care. 2026 Dec;44(1):2697923. doi: 10.1080/02813432.2026.2697923. Epub 2026 Aug 11.
- Derived from this study: PubMed 37908003Tranberg 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.
- Derived from this study: PubMed 37715123Tranberg 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.
- Derived from this study: PubMed 34479646Rozing 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.
- Homepage SOFIA studyLink provided by the sponsor.
- Individual participant dataSharing planned: No. Participants' study information will not be released outside of the study without the written permission of the participant.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanne Reventlow principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SOFIA model in people with Psychiatric Disorder and Schizophrenia, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of the design in terms of recruitment of practices and patients (time frame: 6 months after randomization). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04618250, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.