Telephone Support for Dementia Caregivers

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Geoffrey Tremont, Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT00735800
First received: August 14, 2008
Last updated: May 4, 2015
Last verified: May 2015

August 14, 2008
May 4, 2015
February 2008
May 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00735800 on ClinicalTrials.gov Archive Site
Cost-effectiveness and resource use [ Time Frame: Monthly resource check-ins. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Telephone Support for Dementia Caregivers
Psychosocial Telephone Intervention for Dementia Caregivers

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Dementia
  • Behavioral: Family Intervention:Telephone Tracking Support- Caregiver
    Family-based problem solving treatment
    Other Name: FITT-C
  • Behavioral: Telephone Support
    Supportive telephone counseling about caregiving
  • Active Comparator: Supportive Counseling
    Intervention: Behavioral: Telephone Support
  • Experimental: Problem-Solving
    Intervention: Behavioral: Family Intervention:Telephone Tracking Support- Caregiver

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
May 2013
May 2013   (final data collection date for primary outcome measure)

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.
Both
50 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00735800
R01NR010559, R01NR010559
Yes
Geoffrey Tremont, Rhode Island Hospital
Rhode Island Hospital
National Institute of Nursing Research (NINR)
Principal Investigator: Geoffery Tremont, Ph.D Rhode Island Hospital
Rhode Island Hospital
May 2015

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