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临床试验/NCT02730754
NCT02730754已完成不适用

Relationship Between Emotional Disorders (Diabetes Distress and Depression) and Outcomes (Self-care and Clinical) in Adults With Type 2 Diabetes Mellitus in Primary Care: A Retrospective Cohort Study

Universiti Putra Malaysia0 个研究点目标入组 336 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
336
主要终点
Diabetes-related distress measured with Diabetes Distress Scale-17

研究概览

简要总结

This study aims to determine which factors are related to change in diabetes-related distress and change in depressive symptoms after three years of follow-up in Asian adults with type 2 diabetes mellitus in primary care. The investigators will explore the impact of patient demographics, cardiometabolic control, medications adherence, health-related quality of life, self-efficacy and self-management behaviors on diabetes-related distress and depressive symptoms.

详细描述

Patients with type 2 diabetes mellitus (T2DM) have been shown to experience psychological burden and distorted illness perception. These psychological burden include feeling of burned-out, fatigue, distress and depression, and in addition of distorted illness perception often lead to difficulty in coping with the demands of life-style changes and adherence to medication. Diabetes-related distress (DRD) and depressive symptoms (DS) were associated with glycaemic control and medication adherence, and life-styles behaviors, respectively. However, evidence on the relationships between DRD, DS and clinically significant outcomes are scarce in Asian adults with T2DM. Primary care patients who participated before will be re-invited. This is a repeated cross-sectional study of a cohorts of 700 patients who were first studied in 2013 (Emotional Distress in adults with type 2 Diabetes Mellitus & Quality of Life [EDDMQoL] study with the National Medical Research Register (NMRR) identification number: NMRR-12-1167-14158). Demographic data (age, gender, ethnicity, religion, educational level, occupation and monthly income), smoking status, self-perceive social support and health literacy will be collected by questionnaires.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • Those who participated in the EDDMQoL study
  • Adults aged at least 30 year-old
  • Diagnosed of T2DM more than three years ago
  • On regular follow-up with at least three visits in the previous year

排除标准

  • Patients who are pregnant or lactating
  • Having psychiatric/psychological disorders that could impair judgments and memory
  • Patients who cannot read or understand English, Malay or Mandarin

结局指标

主要结局

Diabetes-related distress measured with Diabetes Distress Scale-17

时间窗: Baseline and 3 year

Change in diabetes-related distress

Depressive symptoms measured with Patient Health Questionnaire-9

时间窗: Baseline and 3 year

Change in depressive symptoms

次要结局

  • Diabetes distress measured with Problem Areas in Diabetes Scale (PAID-5)(Through study completion)
  • Diabetes-related distress and depression combined(Baseline and 3 year)
  • Illness perceptions measured with Brief Illness Perception Questionnaire(Through study completion)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Boon-How Chew

Associate Professor

Universiti Putra Malaysia

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