Prevalence Study of Depression in Chinese Patients With Type 2 Diabetes (HK13) (DD2)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Chinese University of Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Asia Diabetes Foundation
Information provided by (Responsible Party):
Juliana Chan, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01277432
First received: January 14, 2011
Last updated: July 3, 2012
Last verified: July 2012
  Purpose

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

Condition Intervention
Diabetes
Depression
Other: Psychiatrist Interview
Other: Depression screening - control

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Multicentre Study to Investigate the Prevalence and Factors Associated With Depression in Chinese Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Depression and psychological well-being [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    1. Depression (PHQ-9, CESD)
    2. Depression Anxiety and Stress Scale (DASS-21)
    3. Diabetes Stress Scale (DSS-17)


Secondary Outcome Measures:
  • Percentage of patients who attain 2 or more of the 'ABC' targets [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    Percentage of patients who attain 2 or more of the following 3 targets:

    1. HbA1c <7%
    2. BP <130/80 mmHg
    3. LDL cholesterol <2.6 mmol/L

  • Self care and Efficacy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    1. Diabetes Empowerment Scale (C-DES)
    2. Summary of Diabetes Self Care Activities (SDSCA-15)

  • Quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Using EuroQol-5D (EQ-5D) tool


Estimated Enrollment: 3500
Study Start Date: July 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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:

  • MINI
  • SSI-28 (somatization)
Other: Psychiatrist Interview

Patients will receive a face-to-face interview by a trained clinician or psychiatrist using the following instruments:

  • MINI
  • SSI-28 (somatization)
Active Comparator: 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;

  1. Patient Health Questionnaire (PHQ-9)
  2. Depression Anxiety and Stress Scale (DASS-21)
  3. Diabetes Distress Scale (DDS-17)
  4. Life events questions (Inter-Heart Study)
  5. Diabetes Empowerment Scale (C-DES 20)
  6. Summary of Diabetes Self Care Activities (SDSCA-15)
  7. Euroqol-5D (EQ-5D)
Other: Depression screening - control

All study participants will undergo;

  1. a comprehensive diabetes assessment by completing a full set of questionnaires and clinical assessments, using the JADE e-portal
  2. a detailed psychological and behavioral assessments using validated questionnaires
  3. several specialist questionnaires on depression, self care and quality of life

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

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01277432

Contacts
Contact: Juliana Chan, MD jchan@cuhk.edu.hk

Locations
China
1st Affiliated Hosp, Peking University Recruiting
Beijing, China
Principal Investigator: Prof Xiao Hui Guo         
China-Japan Friendship Hospital Recruiting
Beijing, China
Principal Investigator: Prof Wenying Yang         
Peking Union Hospital Recruiting
Beijing, China
Principal Investigator: Prof Xiaoping Xing         
Peking University People's Hospital Recruiting
Bejing, China
Principal Investigator: Prof Linong Ji         
Third Affiliated Hospital of Sun Yat-Sen University Recruiting
Guangzhou, China
Principal Investigator: Prof Jianping Weng         
Shanghai Sixth People's Hospital Recruiting
Shanghai, China
Principal Investigator: Prof Weiping Jia         
Hong Kong
YCK Diabetes Assessment Centre, Prince of Wales Hospital Recruiting
Shatin, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Asia Diabetes Foundation
Investigators
Principal Investigator: Juliana Chan, MD Chinese University of Hong Kong
  More Information

Additional Information:
No publications provided

Responsible Party: Juliana Chan, Professor Chan, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01277432     History of Changes
Other Study ID Numbers: CRE-2010-281
Study First Received: January 14, 2011
Last Updated: July 3, 2012
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:
Diabetes
Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Diabetes Mellitus
Diabetes Mellitus, Type 2
Behavioral Symptoms
Endocrine System Diseases
Glucose Metabolism Disorders
Mental Disorders
Metabolic Diseases
Mood Disorders

ClinicalTrials.gov processed this record on October 29, 2014