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OpenTrials
Completed

NCT Number: NCT00052104

Telephone-Based Support for Caregivers of Patients With Dementia

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive-Behavioral Family Systems Intervention

Behavioral

Sponsors and collaborators

Lead sponsor

Rhode Island Hospital

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

A Telephone Intervention for Dementia Caregivers

Important dates

Study start
2001
Primary completion
2005
Study completion
2005
First posted
Jan 23, 2003
Registry last updated
Aug 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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