Telephone-Based Support for Caregivers of Patients With Dementia

Phase 2

Completed

• Conditions: Dementia

• Registration Number: NCT00052104
• Lead Sponsor: Rhode Island Hospital

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 Timeline

• Study Start: 2001-12
• Study First Submitted: 2003-01-22
• Study First Submitted QC: 2003-01-22
• Study First Posted: 2003-01-23
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Status Verified: 2008-03
• Last Update Submitted: 2013-08-07
• Last Update Posted: 2013-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States