NCT02730754

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
336

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 6, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 12, 2018

Status Verified

October 1, 2018

Enrollment Period

6 months

First QC Date

March 29, 2016

Last Update Submit

October 9, 2018

Conditions

Type 2 Diabetes Mellitus

Keywords

Mood DisordersIllness PerceptionPrimary CareMedication Adherence

Outcome Measures

Primary Outcomes (2)

  • Diabetes-related distress measured with Diabetes Distress Scale-17

    Change in diabetes-related distress

    Baseline and 3 year

  • Depressive symptoms measured with Patient Health Questionnaire-9

    Change in depressive symptoms

    Baseline and 3 year

Secondary Outcomes (3)

  • Diabetes-related distress and depression combined

    Baseline and 3 year

  • Illness perceptions measured with Brief Illness Perception Questionnaire

    Through study completion

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

    Through study completion

Other Outcomes (4)

  • Variability in HbA1c

    Baseline and 3-year

  • Variability in systolic blood pressure

    Baseline and 3-year

  • Variability in pulse rates

    Baseline and 3-year

  • +1 more other outcomes

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 29089913BACKGROUND

  • 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.

    PMID: 29802952BACKGROUND

  • 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.

    PMID: 28774271RESULT

  • 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.

    PMID: 34116645DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Mood DisordersMedication Adherence

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesMental DisordersPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Boon How Chew, MMed

    Universiti Putra Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 29, 2016

First Posted

April 6, 2016

Study Start

April 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

October 12, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will share

Anonymous data will be made available in figshare