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Telephone Support for Dementia Caregivers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Rhode Island Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by:
Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT00735800
First received: August 14, 2008
Last updated: April 5, 2011
Last verified: April 2011
History of Changes
  Purpose

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 Intervention Phase
Dementia
 Behavioral: Family Intervention:Telephone Tracking Support- Caregiver
Behavioral: Telephone Support
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Psychosocial Telephone Intervention for Dementia Caregivers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rhode Island Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cost-effectiveness and resource use [ Time Frame: Monthly resource check-ins. ] [ Designated as safety issue: No ]

Estimated Enrollment: 274
Study Start Date: February 2008
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

Patient:

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

Caregiver:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00735800

Contacts
Contact: Christine Grover 401-444-4528 cgrover@lifespan.org

Locations
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02905
Sponsors and Collaborators
Rhode Island Hospital
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Geoffery Tremont, Ph.D Rhode Island Hospital
  More Information

Publications:

Responsible Party: Geoffrey Tremont, PhD, Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT00735800     History of Changes
Other Study ID Numbers: R01NR010559, R01NR010559
Study First Received: August 14, 2008
Last Updated: April 5, 2011
Health Authority: United States: Federal Government

Keywords provided by Rhode Island Hospital:
Dementia
Caregivers
Alzheimer's disease

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013