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

Primary Purpose

Depression

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Sertraline
Sponsored by
Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Depression focused on measuring elderly, care management, primary care

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zhejiang UniveristyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Depression Care Management

Care as Usual

Arm Description

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

Outcomes

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)
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

Full Information

First Posted
January 27, 2011
Last Updated
January 28, 2011
Sponsor
Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT01287494
Brief Title
Depression Care Management for Depressed Elders in China Primary Care
Acronym
DCM
Official Title
Collaborative Care for Depressed Elders in China
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
July 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Zhejiang University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
elderly, care management, primary care

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Depression Care Management
Arm Type
Experimental
Arm Description
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
Arm Title
Care as Usual
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Sertraline
Other Intervention Name(s)
Zoloft
Intervention Description
dosage form: Capsule dosage: 50-200mg/d frequency: once per day duration: 16 weeks
Primary Outcome Measure Information:
Title
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)
Description
16 weeks treatment with Sertraline and following up 2 years
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shulin Chen, MD&PhD
Phone
86-571-88273337
Email
csl@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ju Zhang, PhD
Organizational Affiliation
Zhejiang University
Official's Role
Study Director
Facility Information:
Facility Name
Zhejiang Univeristy
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310028
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Cao, Master
Phone
86-571-88981775
Email
kyycy@zju.edu.cn
First Name & Middle Initial & Last Name & Degree
Baihua XU, PhD
Phone
86-571-88273336
Email
xubaihua501@126.com
First Name & Middle Initial & Last Name & Degree
Shulin Chen, MD&PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
20029795
Citation
Chen S, Chiu H, Xu B, Ma Y, Jin T, Wu M, Conwell Y. Reliability and validity of the PHQ-9 for screening late-life depression in Chinese primary care. Int J Geriatr Psychiatry. 2010 Nov;25(11):1127-33. doi: 10.1002/gps.2442.
Results Reference
background
PubMed Identifier
26360086
Citation
Chen S, Conwell Y, He J, Lu N, Wu J. Depression care management for adults older than 60 years in primary care clinics in urban China: a cluster-randomised trial. Lancet Psychiatry. 2015 Apr;2(4):332-9. doi: 10.1016/S2215-0366(15)00002-4. Epub 2015 Mar 31. Erratum In: Lancet Psychiatry. 2015 May;2(5):378.
Results Reference
derived
PubMed Identifier
21569445
Citation
Chen S, Conwell Y, Xu B, Chiu H, Tu X, Ma Y. Depression care management for late-life depression in China primary care: protocol for a randomized controlled trial. Trials. 2011 May 13;12:121. doi: 10.1186/1745-6215-12-121.
Results Reference
derived

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Depression Care Management for Depressed Elders in China Primary Care

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