DCM: Depression Care Management for Depressed Elders in China Primary Care

• Sponsor: Zhejiang University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01287494
• Collaborator: (none)
• Enrollment: 320
• Location: 1
• Arms: 2
• Duration (Months): 47
• Patients Per Site Per Month: 6.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Depression	Drug: Sertraline	Phase 4

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 320 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Collaborative Care for Depressed Elders in China
• Study Start Date: Aug 1, 2010
• Anticipated Primary Completion Date: Feb 1, 2014
• Anticipated Study Completion Date: Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Zoloft
No Intervention: Care as Usual

Outcome Measures

Primary Outcome Measures

1. 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]

   16 weeks treatment with Sertraline and following up 2 years

Secondary Outcome Measures

1. 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 [28 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	Zhejiang Univeristy	Hangzhou	Zhejiang	China	310028

Sponsors and Collaborators

• Zhejiang University

Investigators

• Study Director: Ju Zhang, PhD, Zhejiang University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• ClinicalTrials.gov Identifier: NCT01287494
• Other Study ID Numbers: DCM in China
• First Posted: Feb 1, 2011
• Last Update Posted: Feb 1, 2011
• Last Verified: Jan 1, 2011

• Keywords provided by , ,: elderly; care management; primary care
• Additional relevant MeSH terms: Depression; Depressive Disorder; Sertraline

Study Results

No Results Posted as of Feb 1, 2011