Telephone Support for Dementia Caregivers
Primary Purpose
Dementia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Family Intervention:Telephone Tracking Support- Caregiver
Telephone Support
Sponsored by
About this trial
This is an interventional supportive care trial for Dementia focused on measuring Dementia, Caregivers, Alzheimer's disease
Eligibility 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.
Sites / Locations
- Rhode Island Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Supportive Counseling
Problem-Solving
Arm Description
Outcomes
Primary Outcome Measures
Depression, burden, reaction to memory and behavior problems
Secondary Outcome Measures
Cost-effectiveness and resource use
Full Information
NCT ID
NCT00735800
First Posted
August 14, 2008
Last Updated
May 4, 2015
Sponsor
Rhode Island Hospital
Collaborators
National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT00735800
Brief Title
Telephone Support for Dementia Caregivers
Official Title
Psychosocial Telephone Intervention for Dementia Caregivers
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rhode Island Hospital
Collaborators
National Institute of Nursing Research (NINR)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
Dementia, Caregivers, Alzheimer's disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supportive Counseling
Arm Type
Active Comparator
Arm Title
Problem-Solving
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Family Intervention:Telephone Tracking Support- Caregiver
Other Intervention Name(s)
FITT-C
Intervention Description
Family-based problem solving treatment
Intervention Type
Behavioral
Intervention Name(s)
Telephone Support
Intervention Description
Supportive telephone counseling about caregiving
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Cost-effectiveness and resource use
Time Frame
Monthly resource check-ins.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geoffery Tremont, Ph.D
Organizational Affiliation
Rhode Island Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18376128
Citation
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.
Results Reference
background
PubMed Identifier
17308226
Citation
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.
Results Reference
background
PubMed Identifier
18838742
Citation
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.
Results Reference
background
PubMed Identifier
16449755
Citation
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.
Results Reference
background
PubMed Identifier
17548782
Citation
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.
Results Reference
background
PubMed Identifier
16397397
Citation
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.
Results Reference
background
PubMed Identifier
20228893
Citation
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.
Results Reference
background
Links:
URL
http://www.rhodeislandhospital.org/rih/services/alzheimers/Dementia.htm
Description
Link to study webpage
Learn more about this trial
Telephone Support for Dementia Caregivers
We'll reach out to this number within 24 hrs