Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-27 @ 11:57 PM
Study NCT ID:
NCT01287494
Status:
UNKNOWN
Last Update Posted:
2011-02-01
First Post:
2011-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Depression Care Management for Depressed Elders in China Primary Care
Sponsor:
Zhejiang University
Organization:
Study Overview
Official Title:
Collaborative Care for Depressed Elders in China
Status:
UNKNOWN
Status Verified Date:
2011-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DCM
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 (agedā„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.
* 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: