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

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ClinicalTrials.gov Identifier: NCT02730754
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : October 12, 2018
Ministry of Health, Malaysia
UMC Utrecht
Information provided by (Responsible Party):
Boon-How Chew, 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.

Condition or disease
Type 2 Diabetes Mellitus

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.

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Study Type : Observational
Actual Enrollment : 336 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official 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
Study Start Date : April 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who participated before in the EDDMQoL in 2013 (NMRR ID: NMRR-12-1167-14158)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02730754

Sponsors and Collaborators
Universiti Putra Malaysia
Ministry of Health, Malaysia
UMC Utrecht
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Principal Investigator: Boon How Chew, MMed Universiti Putra Malaysia
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Boon-How Chew, Associate Professor, Universiti Putra Malaysia
ClinicalTrials.gov Identifier: NCT02730754    
Other Study ID Numbers: NMRR-15-2214-28139
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymous data will be made available in figshare
Keywords provided by Boon-How Chew, Universiti Putra Malaysia:
Mood Disorders
Illness Perception
Primary Care
Medication Adherence
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases