跳至主要内容
临床试验/NCT03428308
NCT03428308Unknown不适用

Detection and Treatment of Selected Somatic Chronic Diseases in Patients With Severe Mental Disease: Development and Testing of a Coordinated Interdisciplinary and Intersectoral Intervention

Intersectoral Research Unit for Health Services0 个研究点目标入组 90 人开始时间: 2018年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
90
主要终点
Identified patients with mental disease

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
36 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

研究组 & 干预措施

Individualized treatment of detected somatic disease(s)

Experimental

干预措施: Screening (Other)

Individualized treatment of detected somatic disease(s)

Experimental

干预措施: Treatment (Other)

结局指标

主要结局

Identified patients with mental disease

时间窗: Baseline

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

Patients with untreated somatic disease

时间窗: Baseline

Proportion of screened individuals in whom untreated somatic disease is identified

Number of follow-up visits

时间窗: 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

Patients attending screening

时间窗: 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

时间窗: Baseline

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

次要结局

  • 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)

研究者

发起方
Intersectoral Research Unit for Health Services
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Anne Marie Lyngsø

Senior researcher, project manager

Intersectoral Research Unit for Health Services

相似试验