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Clinical Trials/NCT02730754
NCT02730754
Completed
Not Applicable

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 sites336 target enrollmentApril 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 2 Diabetes Mellitus
Sponsor
Universiti Putra Malaysia
Enrollment
336
Primary Endpoint
Diabetes-related distress measured with Diabetes Distress Scale-17
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
April 2016
End Date
October 2016
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Boon-How Chew

Associate Professor

Universiti Putra Malaysia

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Diabetes-related distress measured with Diabetes Distress Scale-17

Time Frame: Baseline and 3 year

Change in diabetes-related distress

Depressive symptoms measured with Patient Health Questionnaire-9

Time Frame: Baseline and 3 year

Change in depressive symptoms

Secondary Outcomes

  • 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)

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