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Diabetes | Prevalence Study of Depression in Chinese Patients With Type 2 Diabetes (HK13)

Diabetes research study

What is the primary objective of this study?

The investigators aim to: 1. Estimate the prevalence of depression in a consecutive cohort of Chinese patients diagnosed with Type 2 Diabetes (T2D) living in areas of China with different socioeconomical affluence 2. Examine patients' awareness of the frequent coexistence of these 2 conditions 3. Analyze the associations between depression and T2D, in particularly the role of metabolic control, socioeconomical status and cognitive-psychological-behavioral factors 4. To document the predisposing, precipitating and perpetuating factors for depression and their interrelationships in Chinese type 2 diabetic patients

Who is eligible to participate?

Inclusion Criteria: 1. Patients diagnosed with type 2 diabetes 2. Aged ≥25 and <75 years inclusive 3. Chinese ethnicity Exclusion Criteria: 1. Patients with mental/physical handicap and/or difficulty in communication such as deafness, mental retardation 2. Patients with disabling diseases or reduced life expectancy such as severe heart failure, stroke, respiratory diseases, or late stages of cancer 3. Patients diagnosed with type 1 diabetes, defined as presentation with diabetic ketoacidosis or unprovoked ketosis or requirement of continuous insulin requirement within 12 months of diagnosis

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Diabetes

Depression

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:Psychiatrist InterviewPatients will receive a face-to-face interview by a trained clinician or psychiatrist using the following instruments: MINI SSI-28 (somatization)

Other:Depression screening - controlAll study participants will undergo; a comprehensive diabetes assessment by completing a full set of questionnaires and clinical assessments, using the JADE e-portal a detailed psychological and behavioral assessments using validated questionnaires several specialist questionnaires on depression, self care and quality of life

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Psychiatrist interviewAll patients will receive the same assessments as the 'active comparator' arm, but in addition those patients found to have positive symptoms for mild to severe depression by PHQ9 or CESD (PHQ>10 and/or CES>16) and a random sample of subjects with no or mild symptoms will also undergo a face-to-face interview by a trained clinician or psychiatrist using the following instruments: MINI SSI-28 (somatization)

Depression screeningAll study participants will undergo a comprehensive diabetes assessment by completing a full set of questionnaires and clinical assessments, using the JADE e-portal. All patients will also undergo detailed psychological and behavioral assessments using validated questionnaires. Several specialist questionnaires will also be conducted with all patients, including those on depression, self care and quality of life; Patient Health Questionnaire (PHQ-9) Depression Anxiety and Stress Scale (DASS-21) Diabetes Distress Scale (DDS-17) Life events questions (Inter-Heart Study) Diabetes Empowerment Scale (C-DES 20) Summary of Diabetes Self Care Activities (SDSCA-15) Euroqol-5D (EQ-5D)

Study Status

Completed

Start Date: July 2010

Completed Date: February 2015

Phase:

Type: Observational

Design:

Primary Outcome: Depression and psychological well-being

Secondary Outcome: Percentage of patients who attain 2 or more of the 'ABC' targets

Study sponsors, principal investigator, and references

Principal Investigator: Juliana Chan, MD

Lead Sponsor: Chinese University of Hong Kong

Collaborator: Asia Diabetes Foundation

More information:https://clinicaltrials.gov/show/NCT01277432

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