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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02730754
Acronym
EDDMQoL-Pro
Enrollment
336
Registered
2016-04-06
Start date
2016-04-30
Completion date
2016-10-31
Last updated
2018-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

Mood Disorders, Illness Perception, Primary Care, Medication Adherence

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.

Interventions

None listed

Sponsors

Ministry of Health, Malaysia
CollaboratorOTHER_GOV
UMC Utrecht
CollaboratorOTHER
Universiti Putra Malaysia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Diabetes-related distress measured with Diabetes Distress Scale-17Baseline and 3 yearChange in diabetes-related distress
Depressive symptoms measured with Patient Health Questionnaire-9Baseline and 3 yearChange in depressive symptoms

Secondary

MeasureTime frameDescription
Diabetes-related distress and depression combinedBaseline and 3 yearChange in both diabetes-related distress and depressive symptoms combined
Illness perceptions measured with Brief Illness Perception QuestionnaireThrough study completionCross-sectional, an association with other variables
Diabetes distress measured with Problem Areas in Diabetes Scale (PAID-5)Through study completionCross-sectional, an association with other variables

Other

MeasureTime frameDescription
Variability in pulse ratesBaseline and 3-yearStandard deviations of the pulse rates from the medical records
Variability in systolic blood pressureBaseline and 3-yearStandard deviations of the systolic blood pressures from the medical records
Health care utilisation/hospitalisation3-yearRetrospective records of the number of visits to healthcare facilities and hospitalisation from the medical records
Variability in HbA1cBaseline and 3-yearStandard deviations of the HbA1c from the medical records

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026