We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Telephone Support for Dementia Caregivers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00735800
Recruitment Status : Completed
First Posted : August 15, 2008
Last Update Posted : May 5, 2015
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Geoffrey Tremont, Rhode Island Hospital

Brief Summary:
Caring for a patient with dementia is associated with increased feelings of burden and depression. The proposed study will examine the efficacy of Family Intervention: Telephone Tracking - Dementia (FITT-Dementia), a multi-component, family-based, telephone intervention, as a tool to reduce caregiver stress.

Condition or disease Intervention/treatment Phase
Dementia Behavioral: Family Intervention:Telephone Tracking Support- Caregiver Behavioral: Telephone Support Phase 2

Detailed Description:

A previous pilot study of this approach showed reduced burden and reaction to memory and behavior problems for dementia caregivers. This study will test the intervention in a larger group of caregivers and have a more detailed analysis of outcomes.

The caregiver of a person with dementia will receive telephone support calls. They will receive telephone calls from a trained member of the research team. These calls will occur over a six-month period and will be scheduled at a time that is convenient for the caregiver. They will receive a total of 16 calls over 6 months. During each call, the support person will discuss their current caregiving situation and provide various forms of support.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Psychosocial Telephone Intervention for Dementia Caregivers
Study Start Date : February 2008
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

Arm Intervention/treatment
Active Comparator: Supportive Counseling Behavioral: Telephone Support
Supportive telephone counseling about caregiving

Experimental: Problem-Solving Behavioral: Family Intervention:Telephone Tracking Support- Caregiver
Family-based problem solving treatment
Other Name: FITT-C

Primary Outcome Measures :
  1. Depression, burden, reaction to memory and behavior problems [ Time Frame: Every two months, over a 6 month time-period , and a three month follow-up ]

Secondary Outcome Measures :
  1. Cost-effectiveness and resource use [ Time Frame: Monthly resource check-ins. ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 1) Diagnosis of dementia;
  • 2) mild to moderate dementia;
  • 3) family member or other adult in caregiver role for at least 6 months, and who provides at least 4 hours of supervision or direct assistance per day for the person with dementia;
  • 4) care recipient lives in the community, including senior/retirement centers, but excluding nursing homes and assisted living centers; and
  • 5) there is no plan for the care recipient to be placed in long term care or the caregiver to end their role within the next 6 months

Exclusion Criteria:


  • 1) other major medical condition affecting independent functioning
  • 2) older than age 90; and
  • 3) younger than age 50.


  • 1) major acute medical illness;
  • 2) English not primary language;
  • 3) cognitive impairment;
  • 4) no access to a telephone; or
  • 5) older than age 90.

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): NCT00735800

Layout table for location information
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02905
Sponsors and Collaborators
Rhode Island Hospital
National Institute of Nursing Research (NINR)
Layout table for investigator information
Principal Investigator: Geoffery Tremont, Ph.D Rhode Island Hospital
Additional Information:

Layout table for additonal information
Responsible Party: Geoffrey Tremont, Director, Neuropsychology, Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT00735800    
Other Study ID Numbers: R01NR010559 ( U.S. NIH Grant/Contract )
R01NR010559 ( U.S. NIH Grant/Contract )
First Posted: August 15, 2008    Key Record Dates
Last Update Posted: May 5, 2015
Last Verified: May 2015
Keywords provided by Geoffrey Tremont, Rhode Island Hospital:
Alzheimer's disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders