- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00735800
Telephone Support for Dementia Caregivers
Psychosocial Telephone Intervention for Dementia Caregivers
Study Overview
Status
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Rhode Island
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Providence, Rhode Island, United States, 02905
- Rhode Island Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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Supportive telephone counseling about caregiving
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Experimental: Problem-Solving
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Family-based problem solving treatment
Other Names:
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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
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Every two months, over a 6 month time-period , and a three month follow-up
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cost-effectiveness and resource use
Time Frame: Monthly resource check-ins.
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Monthly resource check-ins.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Geoffery Tremont, Ph.D, Rhode Island Hospital
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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