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Detection and Treatment of Somatic Disease in Patients With Severe Mental Disease

Primary Purpose

Ischemia, Cardiac Insufficiency, Diabetes Mellitus, Type 2

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Screening
Treatment
Sponsored by
Intersectoral Research Unit for Health Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Ischemia

Eligibility Criteria

36 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Individualized treatment of detected somatic disease(s)

    Arm Description

    Outcomes

    Primary Outcome Measures

    Identified patients with mental disease
    Proportion of individuals identified with the selected mental diseases from the general practitioner's total population
    Patients attending screening
    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
    Proportion of screened individuals who are diagnosed with one or more of the selected somatic diseases
    Patients with untreated somatic disease
    Proportion of screened individuals in whom untreated somatic disease is identified
    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

    Secondary Outcome Measures

    Appropriateness of medical treatment
    Whether the patients' medical treatment is appropriate is assessed using the Medication Appropriateness Index (MAI)
    Change in HbA1c (blood test)
    Assessment of change in HbA1c since baseline for the participants for whom medical treatment has been initiated
    Change in body weight
    Assessment of change in body weight (kilograms) since baseline for the participants for whom medical treatment has been initiated
    Change in blood pressure
    Assessment of change in blood pressure (mmHg) since baseline for the participants for whom medical treatment has been initiated
    Change in blood cholesterol (blood test)
    Assessment of change in blood cholesterol since baseline for the participants for whom medical treatment has been initiated

    Full Information

    First Posted
    January 26, 2018
    Last Updated
    February 8, 2018
    Sponsor
    Intersectoral Research Unit for Health Services
    Collaborators
    The City of Copenhagen, Mental Health Centre Copenhagen, Research Unit Of General Practice, Copenhagen, Bispebjerg Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03428308
    Brief Title
    Detection and Treatment of Somatic Disease in Patients With Severe Mental Disease
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2018 (Anticipated)
    Primary Completion Date
    April 2019 (Anticipated)
    Study Completion Date
    December 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Intersectoral Research Unit for Health Services
    Collaborators
    The City of Copenhagen, Mental Health Centre Copenhagen, Research Unit Of General Practice, Copenhagen, Bispebjerg Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ischemia, Cardiac Insufficiency, Diabetes Mellitus, Type 2, Hypertension, Hypercholesterolemia, Severe Mental Disorder

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    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)
    Allocation
    N/A
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Individualized treatment of detected somatic disease(s)
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    Screening
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Treatment
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Identified patients with mental disease
    Description
    Proportion of individuals identified with the selected mental diseases from the general practitioner's total population
    Time Frame
    Baseline
    Title
    Patients attending screening
    Description
    Proportion of individuals who attend screening out of the total population of individuals who indicate via telephone their wish to participate
    Time Frame
    Baseline
    Title
    Patients diagnosed with somatic disease
    Description
    Proportion of screened individuals who are diagnosed with one or more of the selected somatic diseases
    Time Frame
    Baseline
    Title
    Patients with untreated somatic disease
    Description
    Proportion of screened individuals in whom untreated somatic disease is identified
    Time Frame
    Baseline
    Title
    Number of follow-up visits
    Description
    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
    Time Frame
    One year
    Secondary Outcome Measure Information:
    Title
    Appropriateness of medical treatment
    Description
    Whether the patients' medical treatment is appropriate is assessed using the Medication Appropriateness Index (MAI)
    Time Frame
    One year
    Title
    Change in HbA1c (blood test)
    Description
    Assessment of change in HbA1c since baseline for the participants for whom medical treatment has been initiated
    Time Frame
    One year
    Title
    Change in body weight
    Description
    Assessment of change in body weight (kilograms) since baseline for the participants for whom medical treatment has been initiated
    Time Frame
    One year
    Title
    Change in blood pressure
    Description
    Assessment of change in blood pressure (mmHg) since baseline for the participants for whom medical treatment has been initiated
    Time Frame
    One year
    Title
    Change in blood cholesterol (blood test)
    Description
    Assessment of change in blood cholesterol since baseline for the participants for whom medical treatment has been initiated
    Time Frame
    One year
    Other Pre-specified Outcome Measures:
    Title
    Success of inclusion criteria
    Description
    Qualitative interviews with clinicians will be done to assess the success of the inclusion criteria.
    Time Frame
    One year
    Title
    Success of exclusion criteria
    Description
    Qualitative interviews with clinicians will be done to assess the success of the exclusion criteria.
    Time Frame
    One year
    Title
    Success of initiatives for recruiting patients
    Description
    Qualitative interviews with clinicians and municipal contact/support persons will be done to assess the success of the process in incentivizing participants to attend screening and subsequent follow-up visits. Data registration sheets on attendance and telephonic contact with participants will be evaluated.
    Time Frame
    One year
    Title
    Success of screening and treatment
    Description
    Qualitative interviews with clinicians and municipal contact/support persons will be done to assess the success of the process in screening and treating the target individuals in general practice
    Time Frame
    One year
    Title
    Individual benefits
    Description
    Qualitative interviews with clinicians, municipal contact/support persons and participants will be done to assess which individuals benefited from the intervention and which did not.
    Time Frame
    One year
    Title
    Circumstances for success
    Description
    Qualitative interviews with clinicians, municipal contact/support persons and participants will be done to assess the circumstances under which the intervention succeeded.
    Time Frame
    One year
    Title
    Success of intersectoral cooperation
    Description
    Qualitative interviews with clinicians, municipal contact/support persons, psychiatrists, clinical pharmacologists and participants will be done to assess how the intersectoral cooperation functioned.
    Time Frame
    One year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    36 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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) Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Anne Marie Lyngsø, PhD
    Phone
    +4531145637
    Email
    annemarie.lyngsoe@regionh.dk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Julie C Grew, PhD
    Phone
    +4526285755
    Email
    julie.grew@regionh.dk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ane F Bendix, MD
    Organizational Affiliation
    Intersectoral Research Unit for Health Services
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Detection and Treatment of Somatic Disease in Patients With Severe Mental Disease

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