Depression Care Management for Depressed Elders in China Primary Care

NCT01287494 | Unknown Phase 4 DMC

• 1 other identifier: DCM in China
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

elderly; care management; primary care

Outcome Measures

Primary Outcomes (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 treatment with Sertraline and following up 2 years

  16 weeks

Secondary Outcomes (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

Study Arms (2)

Depression Care Management

EXPERIMENTAL

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

Care as Usual

NO INTERVENTION

Interventions

Sertraline DRUG

dosage form: Capsule dosage: 50-200mg/d frequency: once per day duration: 16 weeks

Also known as: Zoloft

Depression Care Management

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

Zhejiang Univeristy

Hangzhou, Zhejiang, 310028, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 20029795 BACKGROUND

• 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.

  PMID: 26360086 DERIVED

• 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.

  PMID: 21569445 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Ju Zhang, PhD

  Zhejiang University

  STUDY DIRECTOR

Central Study Contacts

Shulin Chen, MD&PhD

CONTACT

86-571-88273337; csl@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 27, 2011
• First Posted: February 1, 2011
• Study Start: August 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: July 1, 2014
• Last Updated: February 1, 2011

Record last verified: 2011-01

Locations

CN (1)