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

NCT03428308 | Unknown

• 1 other identifier: CSU-2017-002
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ischemia; Cardiac Insufficiency; Diabetes Mellitus, Type 2; Hypertension; Hypercholesterolemia; Severe Mental Disorder

Outcome Measures

Primary Outcomes (5)

• Identified patients with mental disease

  Proportion of individuals identified with the selected mental diseases from the general practitioner's total population

  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

  Baseline

• Patients diagnosed with somatic disease

  Proportion of screened individuals who are diagnosed with one or more of the selected somatic diseases

  Baseline

• Patients with untreated somatic disease

  Proportion of screened individuals in whom untreated somatic disease is identified

  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

  One year

Secondary Outcomes (5)

• Appropriateness of medical treatment

  One year

• Change in HbA1c (blood test)

  One year

• Change in body weight

  One year

• Change in blood pressure

  One year

• Change in blood cholesterol (blood test)

  One year

Other Outcomes (7)

• Success of inclusion criteria

  One year

• Success of exclusion criteria

  One year

• Success of initiatives for recruiting patients

  One year

Study Arms (1)

Individualized treatment of detected somatic disease(s)

EXPERIMENTAL

Other: Screening; Other: Treatment

Interventions

Screening OTHER

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.

Individualized treatment of detected somatic disease(s)

Treatment OTHER

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.

Individualized treatment of detected somatic disease(s)

Eligibility Criteria

• Age: 36 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Intersectoral Research Unit for Health Services: lead
• The City of Copenhagen: collaborator
• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: collaborator
• Research Unit Of General Practice, Copenhagen: collaborator
• Bispebjerg Hospital: collaborator

MeSH Terms

Conditions

Ischemia; Heart Failure; Diabetes Mellitus, Type 2; Hypertension; Hypercholesterolemia; Mental Disorders

Interventions

Mass Screening; Therapeutics

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Ane F Bendix, MD

  Intersectoral Research Unit for Health Services

  STUDY DIRECTOR

Central Study Contacts

Anne Marie Lyngsø, PhD

CONTACT

+4531145637; annemarie.lyngsoe@regionh.dk

Julie C Grew, PhD

CONTACT

+4526285755; julie.grew@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior researcher, project manager

Model Details: 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.

Study Record Dates

• First Submitted: January 26, 2018
• First Posted: February 9, 2018
• Study Start: April 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: December 1, 2019
• Last Updated: February 9, 2018

Record last verified: 2018-02