Clinical trial NCT02730754: Emotional Disorders and Outcomes in Adults With Type 2 Diabetes Mellitus at Primary Care
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Keywords: Mood Disorders
Illness Perception
Primary Care
Medication Adherence
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Malaysia
name: UMC Utrecht
First posted: 2016-04-06
Enrollment: 336
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who participated before in the EDDMQoL in 2013 (NMRR ID: NMRR-12-1167-14158)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diabetes-related distress measured with Diabetes Distress Scale-17
timeFrame: Baseline and 3 year
measure: Depressive symptoms measured with Patient Health Questionnaire-9
timeFrame: Baseline and 3 year
Secondary outcomes:
measure: Diabetes-related distress and depression combined
timeFrame: Baseline and 3 year
measure: Illness perceptions measured with Brief Illness Perception Questionnaire
timeFrame: Through study completion
measure: Diabetes distress measured with Problem Areas in Diabetes Scale (PAID-5)
timeFrame: Through study completion
Other outcomes:
measure: Variability in HbA1c
timeFrame: Baseline and 3-year
measure: Variability in systolic blood pressure
timeFrame: Baseline and 3-year
measure: Variability in pulse rates
timeFrame: Baseline and 3-year
measure: Health care utilisation/hospitalisation
timeFrame: 3-year
Locations:
Study officials:
affiliation: Universiti Putra Malaysia
name: Boon How Chew, MMed
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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: 10.1186/s12874-017-0394-5.
citation: Chew BH, Hussain H, Supian ZA. Is therapeutic inertia present in hyperglycaemia, hypertension and hypercholesterolaemia management among adults with type 2 diabetes in three health clinics in Malaysia? a retrospective cohort study. BMC Fam Pract. 2021 Jun 11;22(1):111. doi: 10.1186/s12875-021-01472-2.