IschemiaNCT03428308
Detection and Treatment of Somatic Disease in Patients With Severe Mental Disease
A study testing Screening and Treatment in people with Ischemia and Cardiac Insufficiency, run by Intersectoral Research Unit for Health Services.
Trial summary
In Denmark, around 2 % of the population live with severe mental disease. People with severe mental disease live 15-20 years less than the general population. The majority of the years of life lost are a consequence of the excess mortality due to somatic disease. Read more about this study
- Who is it for?
- Ages 36 to 65 years
- Conditions the study is for
- Ischemia, Cardiac Insufficiency, Diabetes Mellitus, Type 2
- What is being tested?
- Screening and Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Apr 2018to Dec 2019
- 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 36 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who appear in their individual general practitioner's record system with one of the following diagnoses:
- Schizophrenia (ICPC code p72)
- Psychosis-schizoaffective disorder without specification (ICPC code p72)
- Bipolar disorder (ICPC code p73)
Who cannot join
- Persons who live in one of the Municipality of Copenhagen's social-psychiatric residences
- Persons with life-threatening disease
- Persons who do not understand and/or speak the Danish language
- Persons with acute suicidal ideation
- Persons with a severe current abuse incompatible with participation
- Persons who are assessed as being a threat to staff
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Detection and Treatment of Selected Somatic Chronic Diseases in Patients With Severe Mental Disease: Development and Testing of a Coordinated Interdisciplinary and Intersectoral Intervention
In Denmark, around 2 % of the population live with severe mental disease. People with severe mental disease live 15-20 years less than the general population. The majority of the years of life lost are a consequence of the excess mortality due to somatic disease. The high prevalence of somatic disease among people with severe mental disease can be largely attributed to physical inactivity, unhealthy diet and side effects from psychopharmacological drugs. Apart from the impacts of unhealthy lifestyle and medication side effects, research suggests that individuals with severe mental disease do not receive the same treatment for their somatic diseases as do the rest of the population. The inequality in diagnostics and treatment can be attributed to stigmatization from healthcare providers and patients' lacking awareness of symptoms and reluctance to seek medical care. Further, the increasing specialization within both somatic and psychiatric care has led to a division between these two treatment systems (8,9). Patients with severe mental disease who simultaneously have one or more somatic diseases need their treatment to be coordinated; such treatment should span general practice, the municipality and the psychiatric and somatic hospital. Accordingly, the following elements are necessary to create effective and coordinated treatment trajectories: detailed preparation, qualitative process evaluation as an integrated part of the courses of treatment, and involvement of all stakeholders from the start.
The overall aim of the project is to optimize the detection of selected chronic somatic diseases, including cardiovascular disease (ischaemia and heart failure), diabetes, hypertension and high cholesterol, in individuals with schizophrenia, schizoaffective disorder or bipolar disorder; to initiate medical treatment; and to ensure treatment compliance among patients.
Read more
Accordingly, the project has the following objectives:
- To develop an intervention targeting individuals with schizophrenia, schizoaffective disorder or bipolar disorder that can optimize the detection of selected chronic somatic diseases, including cardiovascular disease (ischaemia and heart failure), diabetes, hypertension and high cholesterol
- To test whether the developed intervention can optimize the detection of cardiovascular disease (ischaemia and heart failure), diabetes, hypertension and high cholesterol in individuals with schizophrenia, schizoaffective disorder or bipolar disorder
The project's hypotheses are that an interdisciplinary and intersectoral intervention targeting individuals with schizophrenia, schizoaffective disorder or bipolar disorder can
- optimize detection of cardiovascular diseases (ischaemia and cardiac insufficiency), diabetes, hypertension and high cholesterol by systematic screening in general practice
- lead to initiation and maintenance of relevant medical treatment. Moreover, we hypothesize that the complete intervention in a long-term perspective will lead to decreased mortality within the target group.
Read the detailed description
Design, materials and methods:
The project is divided in two phases. In Phase 1 the project's intervention is developed; in Phase 2 the intervention is tested. Phase 2 will be conducted as a feasibility study.
Recruitment:
Based on experience from previous studies, we know the target group can be difficult to recruit and maintain in a course of treatment. We expect that 10-15 patients belonging to each provider-number will meet the project's inclusion criteria. To obtain sufficient patients for the project, we aim to include 20 general practitioners (individual provider-numbers). Accordingly, it is realistic to assume that around 75 patients undergo screening in general practice.
Recruitment of general practitioners will be done by sending written information about project participation and an invitation to participate. Only general practitioners who have one or several practice nurse(s) will be invited. The written invitation will be followed by a telephone call to all invitees to identify those practitioners wishing to participate.
Intervention:
Phase 1: Development of intervention:
The aim of Phase 1 is to design an intervention based on the experiences and perspectives of the involved stakeholders regarding how to optimize detection and treatment of somatic disease among persons with severe mental disease. The project rests on the fundamental idea that it is crucial to involve all relevant stakeholders as early as in the development phase if the intervention is to be effective and feasible to implement in practice. This phase includes 1) meetings with key stakeholders in the field, 2) observations and interviews within the Mental Health Centre Copenhagen and Copenhagen Municipality, 3) multiple project meetings involving all sectors in the project as well as on-going monitoring by the project group.
Phase 2: Testing of the intervention:
The intervention is divided in two parts: a screening intervention and a treatment intervention. The testing of the interventions is conducted as a feasibility study.
Evaluation:
The evaluation is twofold:
- Evaluation of the effect of the intervention
- Evaluation of the implementation process
- Conditions
- Ischemia, Cardiac Insufficiency, Diabetes Mellitus, Type 2, Hypertension, Hypercholesterolemia, Severe Mental Disorder
- Being tested
- Screening, Treatment
- Medical subject headings
- Ischemia, Heart Failure, Diabetes Mellitus, Type 2, Hypertension, Hypercholesterolemia, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScreeningOther
Each individual general practitioner reviews his/her record system and detects patients who meet the inclusion criteria. Patients who meet these criteria will be invited to participate in the project.
TreatmentOther
Patients who are diagnosed with one or more of the selected somatic diseases receive an individualized course of treatment in general practice, primarily focusing on initiation and maintenance of medical treatment, and complying with current clinical guidelines and course programmes. Treatment goals are set in active co-operation with the patient and his/her family and with supervision and support from the Mental Health Centre Copenhagen, clinical pharmacologists and relevant staff from the municipality in terms of contact/support persons.
| Study group | Role | What they receive |
|---|---|---|
| Individualized treatment of detected somatic disease(s) | Experimental | Not described Receives: Other: Screening; Other: Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identified patients with mental disease
Proportion of individuals identified with the selected mental diseases from the general practitioner's total population
Measured: Baseline
Patients attending screening
Proportion of individuals who attend screening out of the total population of individuals who indicate via telephone their wish to participate
Measured: Baseline
Patients diagnosed with somatic disease
Proportion of screened individuals who are diagnosed with one or more of the selected somatic diseases
Measured: Baseline
Patients with untreated somatic disease
Proportion of screened individuals in whom untreated somatic disease is identified
Measured: Baseline
Number of follow-up visits
Number of follow-up visits for participants in whom medical treatment of somatic disease has been initiated is compared with number of visits in general practice the year before the intervention
Measured: One year
Secondary outcomes (5)
Appropriateness of medical treatment
Whether the patients' medical treatment is appropriate is assessed using the Medication Appropriateness Index (MAI)
Measured: One year
Change in HbA1c (blood test)
Assessment of change in HbA1c since baseline for the participants for whom medical treatment has been initiated
Measured: One year
Change in body weight
Assessment of change in body weight (kilograms) since baseline for the participants for whom medical treatment has been initiated
Measured: One year
Change in blood pressure
Assessment of change in blood pressure (mmHg) since baseline for the participants for whom medical treatment has been initiated
Measured: One year
Change in blood cholesterol (blood test)
Assessment of change in blood cholesterol since baseline for the participants for whom medical treatment has been initiated
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study startApr 2018 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IschemiaStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients who meet the inclusion criteria will be identified and invited to participate by their general practitioner. Patients who agree to partcipate will be invited to a screening consultation focusing on selected somatic diseases. Patients who are diagnosed with one or more of the selected somatic diseases will be included in the intervention, which consists of individualized courses of treatment focusing on initiation and maintenance of medical treatment and complying with current clinical guidelines and course programmes. The intervention is planned to run for one year.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intersectoral Research Unit for Health Services
- Sponsor type
- Other government
- Collaborators
- The City of Copenhagen, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital, Research Unit Of General Practice, Copenhagen, Bispebjerg Hospital
- Responsible party
- Principal investigator, Anne Marie Lyngsø, Intersectoral Research Unit for Health Services
- Investigators
- Ane F Bendix, MD, Study director, Intersectoral Research Unit for Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428308
- Sponsor's protocol ID
- CSU-2017-002
- Status last verified
- Feb 2018
- First submitted
- 26 Jan 2018
- Last updated
- 9 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection and Treatment of Selected Somatic Chronic Diseases in Patients With Severe Mental Disease: Development and Testing of a Coordinated Interdisciplinary and Intersectoral Intervention
- ClinicalTrials.gov ID
- NCT03428308
- Acronym / sponsor ID
- CSU-2017-002
- Conditions
- Ischemia, Cardiac Insufficiency, Diabetes Mellitus, Type 2, Hypertension, Hypercholesterolemia, Severe Mental Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Intersectoral Research Unit for Health ServicesOther government
- Collaborators
- The City of Copenhagen, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital, Research Unit Of General Practice, Copenhagen, Bispebjerg Hospital
- Study start
- Apr 2018 (estimated)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 9 Feb 2018 (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.
In Denmark, around 2 % of the population live with severe mental disease. People with severe mental disease live 15-20 years less than the general population. The majority of the years of life lost are a consequence of the excess mortality due to somatic disease. The high prevalence of somatic disease among people with severe mental disease can be largely attributed to physical inactivity, unhealthy diet and side effects from psychopharmacological drugs. Apart from the impacts of unhealthy lifestyle and medication side effects, research suggests that individuals with severe mental disease do not receive the same treatment for their somatic diseases as do the rest of the population. The inequality in diagnostics and treatment can be attributed to stigmatization from healthcare providers and patients' lacking awareness of symptoms and reluctance to seek medical care. Further, the increasing specialization within both somatic and psychiatric care has led to a division between these two treatment systems (8,9). Patients with severe mental disease who simultaneously have one or more somatic diseases need their treatment to be coordinated; such treatment should span general practice, the municipality and the psychiatric and somatic hospital. Accordingly, the following elements are necessary to create effective and coordinated treatment trajectories: detailed preparation, qualitative process evaluation as an integrated part of the courses of treatment, and involvement of all stakeholders from the start.
The overall aim of the project is to optimize the detection of selected chronic somatic diseases, including cardiovascular disease (ischaemia and heart failure), diabetes, hypertension and high cholesterol, in individuals with schizophrenia, schizoaffective disorder or bipolar disorder; to initiate medical treatment; and to ensure treatment compliance among patients.
Accordingly, the project has the following objectives:
- To develop an intervention targeting individuals with schizophrenia, schizoaffective disorder or bipolar disorder that can optimize the detection of selected chronic somatic diseases, including cardiovascular disease (ischaemia and heart failure), diabetes, hypertension and high cholesterol
- To test whether the developed intervention can optimize the detection of cardiovascular disease (ischaemia and heart failure), diabetes, hypertension and high cholesterol in individuals with schizophrenia, schizoaffective disorder or bipolar disorder
The project's hypotheses are that an interdisciplinary and intersectoral intervention targeting individuals with schizophrenia, schizoaffective disorder or bipolar disorder can
- optimize detection of cardiovascular diseases (ischaemia and cardiac insufficiency), diabetes, hypertension and high cholesterol by systematic screening in general practice
- lead to initiation and maintenance of relevant medical treatment. Moreover, we hypothesize that the complete intervention in a long-term perspective will lead to decreased mortality within the target group.
Detailed description
Design, materials and methods:
The project is divided in two phases. In Phase 1 the project's intervention is developed; in Phase 2 the intervention is tested. Phase 2 will be conducted as a feasibility study.
Recruitment:
Based on experience from previous studies, we know the target group can be difficult to recruit and maintain in a course of treatment. We expect that 10-15 patients belonging to each provider-number will meet the project's inclusion criteria. To obtain sufficient patients for the project, we aim to include 20 general practitioners (individual provider-numbers). Accordingly, it is realistic to assume that around 75 patients undergo screening in general practice.
Recruitment of general practitioners will be done by sending written information about project participation and an invitation to participate. Only general practitioners who have one or several practice nurse(s) will be invited. The written invitation will be followed by a telephone call to all invitees to identify those practitioners wishing to participate.
Intervention:
Phase 1: Development of intervention:
The aim of Phase 1 is to design an intervention based on the experiences and perspectives of the involved stakeholders regarding how to optimize detection and treatment of somatic disease among persons with severe mental disease. The project rests on the fundamental idea that it is crucial to involve all relevant stakeholders as early as in the development phase if the intervention is to be effective and feasible to implement in practice. This phase includes 1) meetings with key stakeholders in the field, 2) observations and interviews within the Mental Health Centre Copenhagen and Copenhagen Municipality, 3) multiple project meetings involving all sectors in the project as well as on-going monitoring by the project group.
Phase 2: Testing of the intervention:
The intervention is divided in two parts: a screening intervention and a treatment intervention. The testing of the interventions is conducted as a feasibility study.
Evaluation:
The evaluation is twofold:
- Evaluation of the effect of the intervention
- Evaluation of the implementation process
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients who meet the inclusion criteria will be identified and invited to participate by their general practitioner. Patients who agree to partcipate will be invited to a screening consultation focusing on selected somatic diseases. Patients who are diagnosed with one or more of the selected somatic diseases will be included in the intervention, which consists of individualized courses of treatment focusing on initiation and maintenance of medical treatment and complying with current clinical guidelines and course programmes. The intervention is planned to run for one year.
| Arm | Type | Receives |
|---|---|---|
| Individualized treatment of detected somatic disease(s) | Experimental | Other: Screening, Other: Treatment |
Who may qualify
- Ages
- 36 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who appear in their individual general practitioner's record system with one of the following diagnoses:
- Schizophrenia (ICPC code p72)
- Psychosis-schizoaffective disorder without specification (ICPC code p72)
- Bipolar disorder (ICPC code p73)
Key exclusion criteria (6 listed)
- Persons who live in one of the Municipality of Copenhagen's social-psychiatric residences
- Persons with life-threatening disease
- Persons who do not understand and/or speak the Danish language
- Persons with acute suicidal ideation
- Persons with a severe current abuse incompatible with participation
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 |
|---|---|---|
| ScreeningEach individual general practitioner reviews his/her record system and detects patients who meet the inclusion criteria. Patients who meet these criteria will be invited to participate in the project. | Other | Individualized treatment of detected somatic disease(s) |
| TreatmentPatients who are diagnosed with one or more of the selected somatic diseases receive an individualized course of treatment in general practice, primarily focusing on initiation and maintenance of medical treatment, and complying with current clinical guidelines and course programmes. Treatment goals are set in active co-operation with the patient and his/her family and with supervision and support from the Mental Health Centre Copenhagen, clinical pharmacologists and relevant staff from the municipality in terms of contact/support persons. | Other | Individualized treatment of detected somatic disease(s) |
Primary outcome
Identified patients with mental disease
Time frame: Baseline
Proportion of individuals identified with the selected mental diseases from the general practitioner's total population
Patients attending screening
Time frame: Baseline
Proportion of individuals who attend screening out of the total population of individuals who indicate via telephone their wish to participate
Patients diagnosed with somatic disease
Time frame: Baseline
Proportion of screened individuals who are diagnosed with one or more of the selected somatic diseases
Patients with untreated somatic disease
Time frame: Baseline
Proportion of screened individuals in whom untreated somatic disease is identified
Number of follow-up visits
Time frame: One year
Number of follow-up visits for participants in whom medical treatment of somatic disease has been initiated is compared with number of visits in general practice the year before the intervention
5 secondary outcomes
Appropriateness of medical treatment
Time frame: One year
Change in HbA1c (blood test)
Time frame: One year
Change in body weight
Time frame: One year
Change in blood pressure
Time frame: One year
Change in blood cholesterol (blood test)
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2018.
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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.
Ane F Bendix, MD study director
Intersectoral Research Unit for Health Services
Questions about this trial
What is this clinical trial studying?
A study testing Screening and Treatment in people with Ischemia and Cardiac Insufficiency, run by Intersectoral Research Unit for Health Services.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 9 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne Marie Lyngsø, PhD (+4531145637, annemarie.lyngsoe@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identified patients with mental disease (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2018.