Clinical trial NCT01277432: Prevalence Study of Depression in Chinese Patients With Type 2 Diabetes (HK13)
Official title: A Multicentre Study to Investigate the Prevalence and Factors Associated With Depression in Chinese Patients With Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Depression
Keywords: Diabetes
Depression
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Asia Diabetes Foundation
First posted: 2011-01-17
Enrollment: 3218
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Tertiary Hospitals and community centre

Brief summary: 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

Detailed description: Overall objectives of this multicentre study are to document;

1. the prevalence and diagnosis rates of depression in type 2 diabetic (T2D) patients attending 7 centres in 4 major cities in China including Hong Kong (HK), Shanghai (SH), Guangzhou (GZ) and Beijing (BJ)
2. the predisposing, precipitating and perpetuating factors for depression and their interrelationships in Chinese T2D patients

This study includes two phases. In the phase I pilot study, the investigators shall confirm and compare the validity of Patient Health Questionnaire (PHQ-9) and Clinical Epidemiological Scale for Depression (CESD) in predicting depression in Chinese T2D patients using the SCID as a gold standard. Other questionaires which measure personal and external factors, diabetes associated distress and anxiety, quality of life, mental wellness, self efficacy, health-related behavior and compliance will also be used to document possible predisposing, precipitating and perpetuating factors for depression in diabetes. These results will be used to select a set of tools which are most informative in the evaluation of depression and mental wellness in T2D patients based on their predictions for health behavior, compliance and metabolic control. A random sample of 100 T2D patients will be recruited from 3 Diabetes Centres in GZ, BJ and HK who will complete a full set of questionnaires and structured clinical assessments using a web-based electronic portal. In each of the three centres, all 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 20 subjects with no or mild symptoms will undergo face-to-face interview by psychiatrists using the following instruments: SCID, BDI, SSI-28 (somatization), Coping (Brief Cope 28, Chinese version).

In Phase II, the investigators shall use a subset of the most informative questionaires to document the rates of depression (diagnosed and undiagnosed) and cognitive-psychological-behavioral factors in a consecutive cohort of Chinese patients with T2D and its associations with metabolic control and psychological behavioral factors. In each of the 7 participating centres in HK, SH, BJ and GZ, 500 consecutive patients will undergo comprehensive clinical assessments for risk factors, complications and medications the JADE (Joint Asia Diabetes Evaluation) e-portal, giving a total of 3500 patients.

This survey which documents the rate of depression in T2D patients using similar methodologies will provide a comprehensive data set for exploratory analysis of the multicausality and heterogeneity of clinical presentation and risk factors in Chinese populations. Once this cohort is established and subject to availability of future funding, they can be followed up prospectively to validate and discover risk factors for new onset of depression. Apart from raising awareness, these data are essential in our design of care models and interventions to tailor the unmet needs of these patients. Data from this study will also provide insights into the effects of rapid acculturation and migration on the double burden of diabetes and depression in Chinese populations.

Eligibility criteria: 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

Primary outcomes:
measure: Depression and psychological well-being
timeFrame: 1 year
Secondary outcomes:
measure: Percentage of patients who attain 2 or more of the 'ABC' targets
timeFrame: 1 year
measure: Self care and Efficacy
timeFrame: 1 year
measure: Quality of life
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: 1st Affiliated Hosp, Peking University
city: Beijing
country: China
facility: China-Japan Friendship Hospital
city: Beijing
country: China
facility: Peking Union Hospital
city: Bejing
country: China
facility: Peking University People's Hospital
city: Guangzhou
country: China
facility: Third Affiliated Hospital of Sun Yat-Sen University
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
city: Shatin
country: Hong Kong
facility: YCK Diabetes Assessment Centre, Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Juliana Chan, MD
role: PRINCIPAL_INVESTIGATOR
References: