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

NCT ID: NCT02730754

Last Updated: 2018-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

336 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-10-31

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Malaysia

OTHER_GOV

Sponsor Role collaborator

UMC Utrecht

OTHER

Sponsor Role collaborator

Universiti Putra Malaysia

OTHER

Sponsor Role lead

Responsible Party

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Boon-How Chew

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Boon How Chew, MMed

Role: PRINCIPAL_INVESTIGATOR

Universiti Putra Malaysia

References

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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.

Reference Type BACKGROUND
PMID: 29089913 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29802952 (View on PubMed)

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.

Reference Type RESULT
PMID: 28774271 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34116645 (View on PubMed)

Other Identifiers

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NMRR-15-2214-28139

Identifier Type: -

Identifier Source: org_study_id

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