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AzTrials

Type 2 Diabetes MellitusEDDMQoL-ProNCT02730754

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

An observational study of Type 2 Diabetes Mellitus, run by Universiti Putra Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
How many people
336 participants
Where
No sites listed yet
Study dates
Apr 2016to Oct 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients who participated before in the EDDMQoL in 2013 (NMRR ID: NMRR-12-1167-14158)

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

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

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.

Read the 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.

Keywords
Mood Disorders, Illness Perception, Primary Care, Medication Adherence
Medical subject headings
Diabetes Mellitus, Type 2, Mood Disorders, Medication Adherence

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diabetes-related distress measured with Diabetes Distress Scale-17

    Change in diabetes-related distress

    Measured: Baseline and 3 year

  2. Depressive symptoms measured with Patient Health Questionnaire-9

    Change in depressive symptoms

    Measured: Baseline and 3 year

Secondary outcomes (3)

  1. Diabetes-related distress and depression combined

    Change in both diabetes-related distress and depressive symptoms combined

    Measured: Baseline and 3 year

  2. Illness perceptions measured with Brief Illness Perception Questionnaire

    Cross-sectional, an association with other variables

    Measured: Through study completion

  3. Diabetes distress measured with Problem Areas in Diabetes Scale (PAID-5)

    Cross-sectional, an association with other variables

    Measured: Through study completion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionOct 2016
  4. Study completionOct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
336 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02730754
Sponsor's protocol ID
NMRR-15-2214-28139
Acronym
EDDMQoL-Pro
Status last verified
Oct 2018
First submitted
29 Mar 2016
Last updated
12 Oct 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: Anonymous data will be made available in figshare

Publications

  • 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.

    PubMed 29089913

  • 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.

    PubMed 29802952

  • 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.

    PubMed 28774271

  • 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.

    PubMed 34116645

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes Mellitus, run by Universiti Putra Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diabetes-related distress measured with Diabetes Distress Scale-17 (time frame: Baseline and 3 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02730754, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2018.

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