Back to resultsTelephone-Based Support for Caregivers of Patients With Dementia
Primary Purpose
Dementia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cognitive-Behavioral Family Systems Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Dementia
Eligibility 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
Sites / Locations
- Rhode Island Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00052104
First Posted
January 22, 2003
Last Updated
August 7, 2013
Sponsor
Rhode Island Hospital
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00052104
Brief Title
Telephone-Based Support for Caregivers of Patients With Dementia
Official Title
A Telephone Intervention for Dementia Caregivers
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
December 2001 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
November 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Rhode Island Hospital
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
85 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavioral Family Systems Intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Telephone-Based Support for Caregivers of Patients With Dementia
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