Telephone-Based Support for Caregivers of Patients With Dementia

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT00052104
First received: January 22, 2003
Last updated: August 7, 2013
Last verified: March 2008

January 22, 2003
August 7, 2013
December 2001
November 2005   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00052104 on ClinicalTrials.gov Archive Site
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Telephone-Based Support for Caregivers of Patients With Dementia
A Telephone Intervention for Dementia Caregivers

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Dementia
Behavioral: Cognitive-Behavioral Family Systems Intervention
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
85
November 2005
November 2005   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00052104
R21 MH62561, R21MH062561, DSIR GT-GS
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Rhode Island Hospital
National Institute of Mental Health (NIMH)
Not Provided
Rhode Island Hospital
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP