Depression Care Management for Depressed Elders in China Primary Care (DCM)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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
- 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
|
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 |
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| Contact: Shulin Chen, MD&PhD | 86-571-88273337 | csl@zju.edu.cn |
| 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 | |
| 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 Mood Disorders Mental Disorders Sertraline Antidepressive Agents Psychotropic Drugs Central Nervous System Agents |
Therapeutic Uses Pharmacologic Actions Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013