- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01277432
Prevalence Study of Depression in Chinese Patients With Type 2 Diabetes (HK13) (DD2)
A Multicentre Study to Investigate the Prevalence and Factors Associated With Depression in Chinese Patients With Type 2 Diabetes
The investigators aim to:
- 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
- Examine patients' awareness of the frequent coexistence of these 2 conditions
- Analyze the associations between depression and T2D, in particularly the role of metabolic control, socioeconomical status and cognitive-psychological-behavioral factors
- To document the predisposing, precipitating and perpetuating factors for depression and their interrelationships in Chinese type 2 diabetic patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Overall objectives of this multicentre study are to document;
- 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)
- 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Beijing, China
- Peking Union Hospital
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Beijing, China
- China-Japan Friendship Hospital
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Beijing, China
- 1st Affiliated Hosp, Peking University
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Bejing, China
- Peking University People's Hospital
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Guangzhou, China
- Third Affiliated Hospital of Sun Yat-sen University
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Shanghai, China
- Shanghai Sixth People's Hospital
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Shatin, Hong Kong
- YCK Diabetes Assessment Centre, Prince of Wales Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients diagnosed with type 2 diabetes
- Aged ≥25 and <75 years inclusive
- Chinese ethnicity
Exclusion Criteria:
- Patients with mental/physical handicap and/or difficulty in communication such as deafness, mental retardation
- Patients with disabling diseases or reduced life expectancy such as severe heart failure, stroke, respiratory diseases, or late stages of cancer
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Psychiatrist interview
All 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:
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Patients will receive a face-to-face interview by a trained clinician or psychiatrist using the following instruments:
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Depression screening
All 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;
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All study participants will undergo;
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression and psychological well-being
Time Frame: 1 year
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of patients who attain 2 or more of the 'ABC' targets
Time Frame: 1 year
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Percentage of patients who attain 2 or more of the following 3 targets:
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1 year
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Self care and Efficacy
Time Frame: 1 year
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1 year
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Quality of life
Time Frame: 1 year
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Using EuroQol-5D (EQ-5D) tool
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1 year
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Juliana Chan, MD, Chinese University of Hong Kong
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRE-2010-281
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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