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Telephone-Based Support for Caregivers of Patients With Dementia

NCT ID: NCT00052104

Last Updated: 2013-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-12-31

Study Completion Date

2005-11-30

Brief Summary

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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

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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.

Conditions

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Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Cognitive-Behavioral Family Systems Intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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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


* 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

Exclusion Criteria

* Major acute medical condition affecting independent functioning


* Acute medical illness
* Cognitive impairment as defined by an MMSE score \< 25
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Rhode Island Hospital

OTHER

Sponsor Role lead

Locations

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Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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R21MH062561

Identifier Type: NIH

Identifier Source: secondary_id

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DSIR GT-GS

Identifier Type: -

Identifier Source: secondary_id

R21MH062561

Identifier Type: NIH

Identifier Source: org_study_id

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