Depression Care Management for Depressed Elders in China Primary Care (DCM)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Zhejiang University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Zhejiang University
ClinicalTrials.gov Identifier:
NCT01287494
First received: January 27, 2011
Last updated: January 28, 2011
Last verified: January 2011
  Purpose

Using a randomized controlled design, the investigators will examine whether the DCM is an effective treatment for patients with late life depression in urban China. Our specific aims are: (1) to determine whether the DCM intervention results in improved outcomes compared with CAU at both the provider (e.g., greater adherence to quality indicators) and patient levels (e.g., greater reduction in depressive symptoms); and (2) to compare DCM with CAU with regard to a range of outcomes in other pertinent domains, both at the provider (e.g., improvements in knowledge/attitudes) and patient (e.g., functioning, satisfaction) levels. The study will take place in 16 primary care clinics (PCCs) randomly assigned to deliver either DCM or CAU (8 clinics each) to 320 patients (aged≥60 years) with major depression (20/clinic; n=160 in each treatment condition). In the DCM arm, PCPs will prescribe 16 weeks of antidepressant medication according to the TG protocol. CMs monitor the progress of treatment and side effects, educate patients/family, and facilitate communication between providers; psychiatrists will provide weekly group psychiatric consultation and CM supervision. Patients in both DCM and CAU arms will be assessed by clinical research coordinators at baseline, 4, 8, 12, 18, and 24 months. HDRS, MMSE, CAS, SF-12, Treatment Stigma and the Client Satisfaction Questionnaire will be used to assess patients' outcomes; and clinic practices, attitudes/knowledge, and satisfaction will be providers' outcomes.


Condition Intervention Phase
Depression
Drug: Sertraline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Collaborative Care for Depressed Elders in China

Resource links provided by NLM:


Further study details as provided by Zhejiang University:

Primary Outcome Measures:
  • the DCM intervention results in improved outcomes compared with CAU at both the provider (e.g., greater adherence to quality indicators) and patient levels (e.g., greater reduction in depressive symptoms) [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
    16 weeks treatment with Sertraline and following up 2 years


Secondary Outcome Measures:
  • compare DCM with CAU with regard to a range of outcomes in other pertinent domains, both at the provider (e.g., improvements in knowledge/attitudes) and patient (e.g., functioning, satisfaction) levels [ Time Frame: 28 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 320
Study Start Date: August 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Depression Care Management

DCM Intervention for Depressed Elders in Primary Care

  • Treatment guidelines (TG): Eight weeks treatment with Sertraline, another 8 weeks treatment augmentation with Bupropion if patients fail to respond in the initial trial, For more complicated cases, the transfer to psychiatrists is indicated.
  • Care managers: Screening, Adherence support, psychoeducation and communication.
  • Psychiatric Consultation
Drug: Sertraline
dosage form: Capsule dosage: 50-200mg/d frequency: once per day duration: 16 weeks
Other Name: Zoloft
No Intervention: Care as Usual

Detailed Description:
  • At the patient level: The investigator will gather information about age, gender, education, marital status, living conditions and satisfaction with their economic status, as well as systematic information on suicidal ideation,, psychopathology, medical health, cognitive function, quality of life and stigma and satisfaction for the treatment.
  • At the provider level: the objective of research measures at the provider level is to gather social-demographic data such as age, gender, education, marital status, clinical experience among physicians in the participating PCCs as well as systematic information on their attitudes/knowledge regarding depression and clinical practices with the treatment guidelines.
  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 60 years old
  • Community-dwelling residences
  • Capable of independent communication
  • Mini-Mental State Examination (MMSE) score ≥ 18

Exclusion Criteria:

  • Incapable of giving written informed consent to this study
  • Acute high suicide risk at baseline assessment
  • Psychosis
  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: NCT01287494

Contacts
Contact: Shulin Chen, MD&PhD 86-571-88273337 csl@zju.edu.cn

Locations
China, Zhejiang
Zhejiang Univeristy Recruiting
Hangzhou, Zhejiang, China, 310028
Contact: Yang Cao, Master    86-571-88981775    kyycy@zju.edu.cn   
Contact: Baihua XU, PhD    86-571-88273336    xubaihua501@126.com   
Principal Investigator: Shulin Chen, MD&PhD         
Sponsors and Collaborators
Zhejiang University
Investigators
Study Director: Ju Zhang, PhD Zhejiang University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Zhejiang University
ClinicalTrials.gov Identifier: NCT01287494     History of Changes
Other Study ID Numbers: DCM in China
Study First Received: January 27, 2011
Last Updated: January 28, 2011
Health Authority: China: Ministry of Health

Keywords provided by Zhejiang University:
elderly
care management
primary care

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders
Sertraline
Antidepressive Agents
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014