Emotional Disorders and Outcomes in Adults With Type 2 Diabetes Mellitus at Primary Care

Completed

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: NCT02730754
• Lead Sponsor: Universiti Putra Malaysia

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.

Study Timeline

• Study First Submitted: 2016-03-29
• Study First Submitted QC: 2016-03-31
• Study Start: 2016-04
• Study First Posted: 2016-04-06
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-09
• Last Update Posted: 2018-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 336

Inclusion Criteria

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diabetes-related distress measured with Diabetes Distress Scale-17	Baseline and 3 year	Change in diabetes-related distress
Depressive symptoms measured with Patient Health Questionnaire-9	Baseline and 3 year	Change in depressive symptoms

Secondary Outcome Measures

Name	Time	Method
Diabetes distress measured with Problem Areas in Diabetes Scale (PAID-5)	Through study completion	Cross-sectional, an association with other variables
Diabetes-related distress and depression combined	Baseline and 3 year	Change in both diabetes-related distress and depressive symptoms combined
Illness perceptions measured with Brief Illness Perception Questionnaire	Through study completion	Cross-sectional, an association with other variables