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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00119561 |
The primary goal of the study is documentation of effectiveness of telephone support groups to reduce caregiver burden and stress. Caregivers who participate in intervention (Telephone Support) should experience lower levels of stress, burden and health care utilization (lower use of psychotropic drugs, fewer scheduled/unscheduled medical visits, lower rates of institutionalization, more efficient use of time in managing care recipient problems) compared to those caregivers in Usual Care.
Condition | Intervention |
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Dementia Alzheimer Disease |
Behavioral: Telephone Support |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Testing the Effectiveness of Telephone Support for Dementia Caregivers |
Enrollment: | 154 |
Study Start Date: | February 2005 |
Estimated Study Completion Date: | December 2009 |
Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Telephone support groups
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Behavioral: Telephone Support
Each telephone support group of 5 caregivers and a group leader met 14 times over a year. The hour calls were semi-structured with an educational component and a support component, led by a trained Group Leader. Topics included knowledge of dementia, safety, caregiver health and well being, communication, managing behavioral challenges and caregiver stress and coping.
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2: No Intervention
Usual VA care
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Background: Caregiving can severely limit caregivers' lives. In order to keep their family member at home, dementia caregivers often experience physical and psychological strain, social isolation, loss of time for self, and inability to obtain and/or afford assistance with caregiving tasks. The amount of time spent in providing care for a family member with dementia contributes to these problems. Dementia caregivers report spending around 18 hours per day in caregiving tasks and 3 hours per day in supervision. The high levels of stress involved in caring for a dementia patient and the widespread lack of training in such care can lead to a vicious cycle of ever-increasing health care dependency, first for the patient and secondly for informal caregivers.
Telephone Support Groups have the potential to address caregivers' stress, isolation and education about dementia and its management, leading to sustainable informal caregiving and lower healthcare use and overall VHA expenditures for the veteran patient with dementia.
Objectives: Study objectives are to 1) examine Telephone Support Groups' effectiveness for caregivers, 2) determine whether Telephone Support results in decreases in VHA health care use and costs for the veteran, and decreased VHA and/or non-VHA use and costs for the caregiver, and 3) examine the intervention's effect on caregivers' time spent providing care. The long-term objective is to develop and disseminate the protocol and materials for effective Telephone Support Groups that can be used across the VHA system.
Methods: This randomized clinical trial of 154 caregivers (Black/African American, White/Caucasian, rural, urban) compared dementia caregivers participating in Telephone Support Groups to caregivers whose family members with dementia were receiving usual care. Either the caregiver or the patient had to be a veteran receiving care at the VAMC Memphis. In the treatment condition, there were 15 year-long support groups of one trained group leader and 5 to 6 caregivers. Each support group met 14 times. The one hour calls were semi-structured conference calls with education, coping skills and cognitive restructuring, and support components. A Caregiver Notebook with information on each topic provided materials for the educational sessions.
Topics included knowledge of dementia, safety, caregiver health and well being, communication, managing behavioral challenges, and caregiver stress and coping. A workshop focusing on the same behavior management and stress topics was offered to Usual Care caregivers at the end of their participation.
Data were collected in caregivers' homes by trained Research Associates at baseline, six and twelve months. VHA health care use and data for the veteran were based on the Patient Treatment File (PTF) and the Outpatient Clinic File (OPC) and costs data used the Health Economics Resource Center (HERC) Average Cost Data Sets. Sets.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Caregiver
Care Recipient
Exclusion Criteria:
Caregiver
Care Recipient
Responsible Party: | Department of Veterans Affairs ( Nichols, Linda - Principal Investigator ) |
Study ID Numbers: | IIR 03-287 |
Study First Received: | July 5, 2005 |
Last Updated: | March 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00119561 History of Changes |
Health Authority: | United States: Federal Government |
Caregiver Dementia Alzheimer Disease Telephone Randomized Controlled Trials |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Alzheimer Disease Central Nervous System Diseases Neurodegenerative Diseases |
Brain Diseases Dementia Cognition Disorders Delirium |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Nervous System Diseases Alzheimer Disease Central Nervous System Diseases |
Neurodegenerative Diseases Tauopathies Brain Diseases Dementia |