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

Type 2 Diabetes Mellitus Clinical Trial

— EDDMQoL-Pro  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02730754
• Other study ID #: NMRR-15-2214-28139
• Status: Completed
• Start date: April 2016
• Est. completion date: October 2016

Study information

• Verified date: October 2018
• Source: Universiti Putra Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 336
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Universiti Putra Malaysia	Ministry of Health, Malaysia, UMC Utrecht

References & Publications (3)

Chew BH, Vos RC, Heijmans M, Shariff-Ghazali S, Fernandez A, Rutten GEHM. Validity and reliability of a Malay version of the brief illness perception questionnaire for patients with type 2 diabetes mellitus. BMC Med Res Methodol. 2017 Aug 3;17(1):118. doi — View Citation

Chew BH, Vos RC, Pouwer F, Rutten GEHM. The associations between diabetes distress and self-efficacy, medication adherence, self-care activities and disease control depend on the way diabetes distress is measured: Comparing the DDS-17, DDS-2 and the PAID-5. Diabetes Res Clin Pract. 2018 Aug;142:74-84. doi: 10.1016/j.diabres.2018.05.021. Epub 2018 May 24. — View Citation

Chew BH, Vos RC, Stellato RK, Rutten GEHM. Diabetes-Related Distress and Depressive Symptoms Are Not Merely Negative over a 3-Year Period in Malaysian Adults with Type 2 Diabetes Mellitus Receiving Regular Primary Diabetes Care. Front Psychol. 2017 Oct 17;8:1834. doi: 10.3389/fpsyg.2017.01834. eCollection 2017. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Variability in HbA1c	Standard deviations of the HbA1c from the medical records	Baseline and 3-year
Other	Variability in systolic blood pressure	Standard deviations of the systolic blood pressures from the medical records	Baseline and 3-year
Other	Variability in pulse rates	Standard deviations of the pulse rates from the medical records	Baseline and 3-year
Other	Health care utilisation/hospitalisation	Retrospective records of the number of visits to healthcare facilities and hospitalisation from the medical records	3-year
Primary	Diabetes-related distress measured with Diabetes Distress Scale-17	Change in diabetes-related distress	Baseline and 3 year
Primary	Depressive symptoms measured with Patient Health Questionnaire-9	Change in depressive symptoms	Baseline and 3 year
Secondary	Diabetes-related distress and depression combined	Change in both diabetes-related distress and depressive symptoms combined	Baseline and 3 year
Secondary	Illness perceptions measured with Brief Illness Perception Questionnaire	Cross-sectional, an association with other variables	Through study completion
Secondary	Diabetes distress measured with Problem Areas in Diabetes Scale (PAID-5)	Cross-sectional, an association with other variables	Through study completion