Telephone-Based Support for Caregivers of Patients With Dementia - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00052104

Purpose

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.

Condition	Intervention	Phase
Dementia	Behavioral: Cognitive-Behavioral Family Systems Intervention	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Telephone Intervention for Dementia Caregivers

Resource links provided by NLM:

MedlinePlus related topics: Caregivers Dementia

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Estimated Enrollment:	85
Study Start Date:	December 2001
Study Completion Date:	November 2005
Primary Completion Date:	November 2005 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00052104

Locations

United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

More Information

No publications provided

Study ID Numbers:	R21 MH62561, DSIR GT-GS
Study First Received:	January 22, 2003
Last Updated:	March 4, 2008
ClinicalTrials.gov Identifier:	NCT00052104 History of Changes
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases

Central Nervous System Diseases
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on November 27, 2009