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Completed

NCT Number: NCT02730754

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Behavior Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Health Behavior Medication Adherence Mental Disorders Metabolic Diseases Mood Disorders Nutritional and Metabolic Diseases Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Diabetes-related distress measured with Diabetes Distress Scale-17

    Time frame: Baseline and 3 year

    Change in diabetes-related distress

  2. Depressive symptoms measured with Patient Health Questionnaire-9

    Time frame: Baseline and 3 year

    Change in depressive symptoms

Secondary outcomes

  1. Diabetes-related distress and depression combined

    Time frame: Baseline and 3 year

    Change in both diabetes-related distress and depressive symptoms combined

  2. Illness perceptions measured with Brief Illness Perception Questionnaire

    Time frame: Through study completion

    Cross-sectional, an association with other variables

  3. Diabetes distress measured with Problem Areas in Diabetes Scale (PAID-5)

    Time frame: Through study completion

    Cross-sectional, an association with other variables

Other outcomes

  1. Variability in HbA1c

    Time frame: Baseline and 3-year

    Standard deviations of the HbA1c from the medical records

  2. Variability in systolic blood pressure

    Time frame: Baseline and 3-year

    Standard deviations of the systolic blood pressures from the medical records

  3. Variability in pulse rates

    Time frame: Baseline and 3-year

    Standard deviations of the pulse rates from the medical records

  4. Health care utilisation/hospitalisation

    Time frame: 3-year

    Retrospective records of the number of visits to healthcare facilities and hospitalisation from the medical records

Sponsors and collaborators

Lead sponsor

Universiti Putra Malaysia

Other

Collaborators

  • Ministry of Health, Malaysia
  • UMC Utrecht

Registry information

Official study title

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

Acronym: EDDMQoL-Pro

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 6, 2016
Registry last updated
Oct 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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