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

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ClinicalTrials.gov Identifier: NCT03428308
Recruitment Status : Not yet recruiting
First Posted : February 9, 2018
Last Update Posted : February 9, 2018
Sponsor:
Collaborators:
The City of Copenhagen
Mental Health Centre Copenhagen
Research Unit Of General Practice, Copenhagen
Bispebjerg Hospital
Information provided by (Responsible Party):
Anne Marie Lyngsø, Intersectoral Research Unit for Health Services

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.

Condition or disease Intervention/treatment Phase
Ischemia Cardiac Insufficiency Diabetes Mellitus, Type 2 Hypertension Hypercholesterolemia Severe Mental Disorder Other: Screening Other: Treatment Not Applicable

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:

  1. Evaluation of the effect of the intervention
  2. Evaluation of the implementation process

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Screening
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
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Disorders

Arm Intervention/treatment
Experimental: Individualized treatment of detected somatic disease(s) Other: Screening
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.

Other: Treatment
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 Measures :
  1. Identified patients with mental disease [ Time Frame: Baseline ]
    Proportion of individuals identified with the selected mental diseases from the general practitioner's total population

  2. 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

  3. Patients diagnosed with somatic disease [ Time Frame: Baseline ]
    Proportion of screened individuals who are diagnosed with one or more of the selected somatic diseases

  4. Patients with untreated somatic disease [ Time Frame: Baseline ]
    Proportion of screened individuals in whom untreated somatic disease is identified

  5. 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


Secondary Outcome Measures :
  1. Appropriateness of medical treatment [ Time Frame: One year ]
    Whether the patients' medical treatment is appropriate is assessed using the Medication Appropriateness Index (MAI)

  2. Change in HbA1c (blood test) [ Time Frame: One year ]
    Assessment of change in HbA1c since baseline for the participants for whom medical treatment has been initiated

  3. Change in body weight [ Time Frame: One year ]
    Assessment of change in body weight (kilograms) since baseline for the participants for whom medical treatment has been initiated

  4. Change in blood pressure [ Time Frame: One year ]
    Assessment of change in blood pressure (mmHg) since baseline for the participants for whom medical treatment has been initiated

  5. Change in blood cholesterol (blood test) [ Time Frame: One year ]
    Assessment of change in blood cholesterol since baseline for the participants for whom medical treatment has been initiated


Other Outcome Measures:
  1. Success of inclusion criteria [ Time Frame: One year ]
    Qualitative interviews with clinicians will be done to assess the success of the inclusion criteria.

  2. Success of exclusion criteria [ Time Frame: One year ]
    Qualitative interviews with clinicians will be done to assess the success of the exclusion criteria.

  3. Success of initiatives for recruiting patients [ Time Frame: One year ]

    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.


  4. Success of screening and treatment [ Time Frame: One year ]
    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

  5. Individual benefits [ Time Frame: One year ]
    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.

  6. Circumstances for success [ Time Frame: One year ]
    Qualitative interviews with clinicians, municipal contact/support persons and participants will be done to assess the circumstances under which the intervention succeeded.

  7. Success of intersectoral cooperation [ Time Frame: One year ]
    Qualitative interviews with clinicians, municipal contact/support persons, psychiatrists, clinical pharmacologists and participants will be done to assess how the intersectoral cooperation functioned.



Information from the National Library of Medicine

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Ages Eligible for Study:   36 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03428308


Contacts
Contact: Anne Marie Lyngsø, PhD +4531145637 annemarie.lyngsoe@regionh.dk
Contact: Julie C Grew, PhD +4526285755 julie.grew@regionh.dk

Sponsors and Collaborators
Intersectoral Research Unit for Health Services
The City of Copenhagen
Mental Health Centre Copenhagen
Research Unit Of General Practice, Copenhagen
Bispebjerg Hospital
Investigators
Study Director: Ane F Bendix, MD Intersectoral Research Unit for Health Services

Responsible Party: Anne Marie Lyngsø, Senior researcher, project manager, Intersectoral Research Unit for Health Services
ClinicalTrials.gov Identifier: NCT03428308     History of Changes
Other Study ID Numbers: CSU-2017-002
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Ischemia
Diabetes Mellitus, Type 2
Hypercholesterolemia
Mental Disorders
Psychotic Disorders
Heart Failure
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Heart Diseases
Cardiovascular Diseases