Telephone Support for Dementia Caregivers

May 4, 2015 updated by: Geoffrey Tremont, Rhode Island Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Rhode Island Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • FITT-C

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Every two months, over a 6 month time-period , and a three month follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Cost-effectiveness and resource use
Time Frame: Monthly resource check-ins.
Monthly resource check-ins.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rhode Island Hospital

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Geoffery Tremont, Ph.D, Rhode Island Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

August 14, 2008

First Submitted That Met QC Criteria

August 14, 2008

First Posted (Estimate)

August 15, 2008

Study Record Updates

Last Update Posted (Estimate)

May 5, 2015

Last Update Submitted That Met QC Criteria

May 4, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01NR010559 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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