Emotional Disorders and Outcomes in Adults With Type 2 Diabetes Mellitus at Primary Care (EDDMQoL-Pro)

October 9, 2018 updated by: Boon-How Chew, Universiti Putra Malaysia

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

336

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who participated before in the EDDMQoL in 2013 (NMRR ID: NMRR-12-1167-14158)

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetes-related distress measured with Diabetes Distress Scale-17
Time Frame: Baseline and 3 year
Change in diabetes-related distress
Baseline and 3 year
Depressive symptoms measured with Patient Health Questionnaire-9
Time Frame: Baseline and 3 year
Change in depressive symptoms
Baseline and 3 year

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variability in HbA1c
Time Frame: Baseline and 3-year
Standard deviations of the HbA1c from the medical records
Baseline and 3-year
Variability in systolic blood pressure
Time Frame: Baseline and 3-year
Standard deviations of the systolic blood pressures from the medical records
Baseline and 3-year
Variability in pulse rates
Time Frame: Baseline and 3-year
Standard deviations of the pulse rates from the medical records
Baseline and 3-year
Health care utilisation/hospitalisation
Time Frame: 3-year
Retrospective records of the number of visits to healthcare facilities and hospitalisation from the medical records
3-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Putra Malaysia

Collaborators

UMC Utrecht
Ministry of Health, Malaysia

Investigators

  • Principal Investigator: Boon How Chew, MMed, Universiti Putra Malaysia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

March 29, 2016

First Submitted That Met QC Criteria

March 31, 2016

First Posted (Estimate)

April 6, 2016

Study Record Updates

Last Update Posted (Actual)

October 12, 2018

Last Update Submitted That Met QC Criteria

October 9, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMRR-15-2214-28139

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymous data will be made available in figshare

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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