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

NCT01277432 | Completed DMC

• 1 other identifier: CRE-2010-281
• Study Type: observational
• Target: 3,218
• Locations: 2 countries
• Sites: 7

Brief Summary

The investigators aim to:

1. 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. 2.Examine patients' awareness of the frequent coexistence of these 2 conditions
3. 3.Analyze the associations between depression and T2D, in particularly the role of metabolic control, socioeconomical status and cognitive-psychological-behavioral factors
4. 4.To document the predisposing, precipitating and perpetuating factors for depression and their interrelationships in Chinese type 2 diabetic patients

Conditions

Diabetes; Depression

Keywords

Diabetes; Depression

Outcome Measures

Primary Outcomes (1)

• Depression and psychological well-being

  1. Depression (PHQ-9, CESD) 2. Depression Anxiety and Stress Scale (DASS-21) 3. Diabetes Stress Scale (DSS-17)

  1 year

Secondary Outcomes (3)

• Percentage of patients who attain 2 or more of the 'ABC' targets

  1 year

• Self care and Efficacy

  1 year

• Quality of life

  1 year

Study Arms (2)

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

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

Interventions

Psychiatrist Interview OTHER

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

Psychiatrist interview

Depression screening - control OTHER

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

Depression screening

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Tertiary Hospitals and community centre

You may qualify if:

• Patients diagnosed with type 2 diabetes
• Aged ≥25 and \<75 years inclusive
• Chinese ethnicity

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Asia Diabetes Foundation: collaborator

Study Sites (7)

1st Affiliated Hosp, Peking University

Beijing, China

Location

China-Japan Friendship Hospital

Beijing, China

Location

Peking Union Hospital

Beijing, China

Location

Peking University People's Hospital

Beijing, China

Location

Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, China

Location

Shanghai Sixth People's Hospital

Shanghai, China

Location

YCK Diabetes Assessment Centre, Prince of Wales Hospital

Shatin, Hong Kong

Location

Related Links

• Works of the Asia Diabetes Foundation

MeSH Terms

Conditions

Diabetes Mellitus; Depression

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavioral Symptoms; Behavior

Study Officials

• Juliana Chan, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Chan

Study Record Dates

• First Submitted: January 14, 2011
• First Posted: January 17, 2011
• Study Start: July 1, 2010
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: August 24, 2015

Record last verified: 2015-08

Locations

HK (1); CN (6)