Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-02-03 @ 10:20 AM
Study NCT ID:
NCT01287494
Status:
UNKNOWN
Last Update Posted:
2011-02-01
First Post:
2011-01-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Depression Care Management for Depressed Elders in China Primary Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020280', 'term': 'Sertraline'}], 'ancestors': [{'id': 'D015057', 'term': '1-Naphthylamine'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 320}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-01-28', 'studyFirstSubmitDate': '2011-01-27', 'studyFirstSubmitQcDate': '2011-01-28', 'lastUpdatePostDateStruct': {'date': '2011-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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)', 'timeFrame': '16 weeks', 'description': '16 weeks treatment with Sertraline and following up 2 years'}], 'secondaryOutcomes': [{'measure': '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', 'timeFrame': '28 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['elderly', 'care management', 'primary care'], 'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '20029795', 'type': 'BACKGROUND', '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.'}, {'pmid': '26360086', 'type': 'DERIVED', '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.'}, {'pmid': '21569445', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '* 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.\n* 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 60 years old\n* Community-dwelling residences\n* Capable of independent communication\n* Mini-Mental State Examination (MMSE) score ≥ 18\n\nExclusion Criteria:\n\n* Incapable of giving written informed consent to this study\n* Acute high suicide risk at baseline assessment\n* Psychosis'}, 'identificationModule': {'nctId': 'NCT01287494', 'acronym': 'DCM', 'briefTitle': 'Depression Care Management for Depressed Elders in China Primary Care', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'Collaborative Care for Depressed Elders in China', 'orgStudyIdInfo': {'id': 'DCM in China'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Depression Care Management', 'description': 'DCM Intervention for Depressed Elders in Primary Care\n\n* 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.\n* Care managers: Screening, Adherence support, psychoeducation and communication.\n* Psychiatric Consultation', 'interventionNames': ['Drug: Sertraline']}, {'type': 'NO_INTERVENTION', 'label': 'Care as Usual'}], 'interventions': [{'name': 'Sertraline', 'type': 'DRUG', 'otherNames': ['Zoloft'], 'description': 'dosage form: Capsule dosage: 50-200mg/d frequency: once per day duration: 16 weeks', 'armGroupLabels': ['Depression Care Management']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310028', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yang Cao, Master', 'role': 'CONTACT', 'email': 'kyycy@zju.edu.cn', 'phone': '86-571-88981775'}, {'name': 'Baihua XU, PhD', 'role': 'CONTACT', 'email': 'xubaihua501@126.com', 'phone': '86-571-88273336'}, {'name': 'Shulin Chen, MD&PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhejiang Univeristy', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Shulin Chen, MD&PhD', 'role': 'CONTACT', 'email': 'csl@zju.edu.cn', 'phone': '86-571-88273337'}], 'overallOfficials': [{'name': 'Ju Zhang, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zhejiang University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Zhejiang University', 'oldOrganization': 'Zhejiang University'}}}}