Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-25 @ 6:59 PM
Study NCT ID:
NCT00052104
Status:
COMPLETED
Last Update Posted:
2013-08-09
First Post:
2003-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Telephone-Based Support for Caregivers of Patients With Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'completionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-07', 'studyFirstSubmitDate': '2003-01-22', 'studyFirstSubmitQcDate': '2003-01-22', 'lastUpdatePostDateStruct': {'date': '2013-08-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Dementia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to develop an effective, low-cost, telephone-based intervention to reduce anxiety, depression, and feelings of burden and stress in caregivers of patients with dementia. This study will also determine whether the intervention can alter the course of dementia.', 'detailedDescription': 'Caregivers are randomized to receive either telephone-based intervention or standard medical care. Both groups receive a resource packet containing information about caring for someone with dementia and a list of local resources. Caregivers in the intervention group also receive a series of telephone calls over 12 months, during which education, emotional support, and training in problem-solving skills are provided by trained therapists. Caregivers in the standard care group receive no additional psychosocial intervention. Participants are assessed pre-treatment, mid-treatment (6 months), post-treatment, and at a 3-month follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Patient Inclusion Criteria:\n\n* DSM-IV diagnosis of dementia (vascular, mixed, or associated with Alzheimer's disease)\n* Lives in the community, including senior/retirement centers, but excluding nursing homes and assisted living centers\n* 50 years old or older\n* Resides in Southeastern New England\n\nCaregiver Inclusion Criteria:\n\n* Living with a person with dementia\n* Provides care for at least 6 months for at least 4 hours a day\n* English as primary language\n* Telephone access\n* Resides in Southeastern New England\n\nPatient Exclusion Criteria:\n\n* Major acute medical condition affecting independent functioning\n\nCaregiver Exclusion Criteria:\n\n* Acute medical illness\n* Cognitive impairment as defined by an MMSE score \\< 25"}, 'identificationModule': {'nctId': 'NCT00052104', 'briefTitle': 'Telephone-Based Support for Caregivers of Patients With Dementia', 'organization': {'class': 'OTHER', 'fullName': 'Rhode Island Hospital'}, 'officialTitle': 'A Telephone Intervention for Dementia Caregivers', 'orgStudyIdInfo': {'id': 'R21MH062561', 'link': 'https://reporter.nih.gov/quickSearch/R21MH062561', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R21MH062561', 'link': 'https://reporter.nih.gov/quickSearch/R21MH062561', 'type': 'NIH'}, {'id': 'DSIR GT-GS'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Cognitive-Behavioral Family Systems Intervention', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Rhode Island Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rhode Island Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}]}}}