NCT00735800

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2008

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 15, 2008

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

May 5, 2015

Status Verified

May 1, 2015

Enrollment Period

5.2 years

First QC Date

August 14, 2008

Last Update Submit

May 4, 2015

Conditions

Keywords

DementiaCaregiversAlzheimer's disease

Outcome Measures

Primary Outcomes (1)

  • Depression, burden, reaction to memory and behavior problems

    Every two months, over a 6 month time-period , and a three month follow-up

Secondary Outcomes (1)

  • Cost-effectiveness and resource use

    Monthly resource check-ins.

Study Arms (2)

Supportive Counseling

ACTIVE COMPARATOR
Behavioral: Telephone Support

Problem-Solving

EXPERIMENTAL
Behavioral: Family Intervention:Telephone Tracking Support- Caregiver

Interventions

Family-based problem solving treatment

Also known as: FITT-C
Problem-Solving

Supportive telephone counseling about caregiving

Supportive Counseling

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) Diagnosis of dementia;
  • \) mild to moderate dementia;
  • \) 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;
  • \) care recipient lives in the community, including senior/retirement centers, but excluding nursing homes and assisted living centers; and
  • \) 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

You may not qualify if:

  • Patient:
  • \) other major medical condition affecting independent functioning
  • \) older than age 90; and
  • \) younger than age 50.
  • Caregiver:
  • \) major acute medical illness;
  • \) English not primary language;
  • \) cognitive impairment;
  • \) no access to a telephone; or
  • \) older than age 90.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02905, United States

Location

Related Publications (7)

  • Bruce JM, McQuiggan M, Williams V, Westervelt H, Tremont G. Burden among spousal and child caregivers of patients with mild cognitive impairment. Dement Geriatr Cogn Disord. 2008;25(4):385-90. doi: 10.1159/000122587. Epub 2008 Mar 29.

    PMID: 18376128BACKGROUND
  • Davis JD, Tremont G. Impact of frontal systems behavioral functioning in dementia on caregiver burden. J Neuropsychiatry Clin Neurosci. 2007 Winter;19(1):43-9. doi: 10.1176/jnp.2007.19.1.43.

    PMID: 17308226BACKGROUND
  • Epstein-Lubow G, Davis JD, Miller IW, Tremont G. Persisting burden predicts depressive symptoms in dementia caregivers. J Geriatr Psychiatry Neurol. 2008 Sep;21(3):198-203. doi: 10.1177/0891988708320972.

    PMID: 18838742BACKGROUND
  • Spitznagel MB, Tremont G, Davis JD, Foster SM. Psychosocial predictors of dementia caregiver desire to institutionalize: caregiver, care recipient, and family relationship factors. J Geriatr Psychiatry Neurol. 2006 Mar;19(1):16-20. doi: 10.1177/0891988705284713.

    PMID: 16449755BACKGROUND
  • Steadman PL, Tremont G, Davis JD. Premorbid relationship satisfaction and caregiver burden in dementia caregivers. J Geriatr Psychiatry Neurol. 2007 Jun;20(2):115-9. doi: 10.1177/0891988706298624.

    PMID: 17548782BACKGROUND
  • Tremont G, Davis JD, Bishop DS. Unique contribution of family functioning in caregivers of patients with mild to moderate dementia. Dement Geriatr Cogn Disord. 2006;21(3):170-4. doi: 10.1159/000090699. Epub 2006 Jan 3.

    PMID: 16397397BACKGROUND
  • Tremont G, Davis JD, Bishop DS, Fortinsky RH. Telephone-Delivered Psychosocial Intervention Reduces Burden in Dementia Caregivers. Dementia (London). 2008;7(4):503-520. doi: 10.1177/1471301208096632.

    PMID: 20228893BACKGROUND

Related Links

MeSH Terms

Conditions

DementiaAlzheimer Disease

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative Diseases

Study Officials

  • Geoffery Tremont, Ph.D

    Rhode Island Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Neuropsychology

Study Record Dates

First Submitted

August 14, 2008

First Posted

August 15, 2008

Study Start

February 1, 2008

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

May 5, 2015

Record last verified: 2015-05

Locations