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
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Condition or disease |
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Type 2 Diabetes Mellitus |
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 |

- 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
- Diabetes-related distress and depression combined [ Time Frame: Baseline and 3 year ]Change in both diabetes-related distress and depressive symptoms combined
- Illness perceptions measured with Brief Illness Perception Questionnaire [ Time Frame: Through study completion ]Cross-sectional, an association with other variables
- Diabetes distress measured with Problem Areas in Diabetes Scale (PAID-5) [ Time Frame: Through study completion ]Cross-sectional, an association with other variables
- Variability in HbA1c [ Time Frame: Baseline and 3-year ]Standard deviations of the HbA1c from the medical records
- Variability in systolic blood pressure [ Time Frame: Baseline and 3-year ]Standard deviations of the systolic blood pressures from the medical records
- Variability in pulse rates [ Time Frame: Baseline and 3-year ]Standard deviations of the pulse rates from the medical records
- Health care utilisation/hospitalisation [ Time Frame: 3-year ]Retrospective records of the number of visits to healthcare facilities and hospitalisation from the medical records

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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 |
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

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
Principal Investigator: | Boon How Chew, MMed | Universiti Putra Malaysia |
Other Publications:
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 |
Mood Disorders Illness Perception Primary Care Medication Adherence |
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |