Telephone-Based Support for Caregivers of Patients With Dementia - Tabular View

Tracking Information
First Received Date ^ICMJE	January 22, 2003
Last Updated Date	March 4, 2008
Start Date ^ICMJE	December 2001
Primary Completion Date	November 2005 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00052104 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Telephone-Based Support for Caregivers of Patients With Dementia
Official Title ^ICMJE	A Telephone Intervention for Dementia Caregivers
Brief Summary	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.
Detailed Description	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.
Study Phase	Phase II, Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Condition ^ICMJE	Dementia
Intervention ^ICMJE	Behavioral: Cognitive-Behavioral Family Systems Intervention
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	85
Completion Date	November 2005
Primary Completion Date	November 2005 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Patient Inclusion Criteria: DSM-IV diagnosis of dementia (vascular, mixed, or associated with Alzheimer's disease) Lives in the community, including senior/retirement centers, but excluding nursing homes and assisted living centers 50 years old or older Resides in Southeastern New England Caregiver Inclusion Criteria: Living with a person with dementia Provides care for at least 6 months for at least 4 hours a day English as primary language Telephone access Resides in Southeastern New England Patient Exclusion Criteria: Major acute medical condition affecting independent functioning Caregiver Exclusion Criteria: Acute medical illness Cognitive impairment as defined by an MMSE score < 25
Gender	Both
Ages	18 Years to 90 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00052104
Responsible Party
Study ID Numbers ^ICMJE	R21 MH62561, DSIR GT-GS
Study Sponsor ^ICMJE	National Institute of Mental Health (NIMH)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute of Mental Health (NIMH)
Verification Date	March 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP