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Telephone-Based Support for Caregivers of Patients With Dementia

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ClinicalTrials.gov Identifier: NCT00052104
Recruitment Status : Completed
First Posted : January 23, 2003
Last Update Posted : August 9, 2013
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Dementia Behavioral: Cognitive-Behavioral Family Systems Intervention Phase 2 Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: A Telephone Intervention for Dementia Caregivers
Study Start Date : December 2001
Primary Completion Date : November 2005
Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00052104

United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Rhode Island Hospital
National Institute of Mental Health (NIMH)
More Information

ClinicalTrials.gov Identifier: NCT00052104     History of Changes
Other Study ID Numbers: R21MH062561 ( U.S. NIH Grant/Contract )
First Posted: January 23, 2003    Key Record Dates
Last Update Posted: August 9, 2013
Last Verified: March 2008

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders