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Dementia |
Senility |
Clinical Trial: A Telehealth Education Program for Caregivers of Veterans with Dementia
This study is currently recruiting patients.
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Purpose
There is a substantial number of older persons with dementia in the U.S. That number is expected to rise, dramatically, in the future because the incidence of dementia increases, exponentially, with age. Also, the oldest old are the fastest growing segment of the U.S. population. Caring for elderly, demented persons can create increased caregiver stress. This can lead to caregiver, “burn out”, and premature institutionalization when caregivers have inadequate coping skills. For these reasons, the need to find an effective and efficient means of meeting the health and social services needs of veterans with dementia will increase sharply in future years.
This study is designed to evaluate the impact of a Telehealth Education Program (TEP) to enhance caregiver’s abilities to communicate with and reduce behavioral symptoms among community dwelling veterans with moderate to severe dementia. In addition, this study will look at the impact of TEP on health care utilization and cost. Also, TEP is a low cost, easily replicable intervention that has the potential to reach many underserved veterans. The study is designed to: 1) evaluate the impact of a Telehealth Education Program (TEP) on outpatient veterans with dementia, 2) help spousal caregivers gain the knowledge and skills necessary to provide the highest quality of care possible for their spouse and to prevent premature institutionalization of the spouse, 3) develop a telehealth training manual for VA clinical staff and a workbook for family members, 4) improve the biopsychosocial well-being of outpatients with dementia and their caregivers throughout the U.S., while reducing unnecessary health care utilization and premature institutionalization.
One hundred-sixty veterans with dementia and their spouses will be recruited throughout VISN 2, randomly assigned to TEP or a usual care group (UC), and assessed at baseline, and at three and twelve months after baseline. The study will employ a 2x3x2 (2 intervention conditions, 3 times of measurement, 2 leaders) randomized control group design. The TEP intervention groups will be involved in a ten session psychoeducational program delivered to caregivers by telephone.
Three hypotheses will be examined. Compared with UC veterans and caregivers, (1) TEP veterans will experience significant (<0.05) reduction in agitation, behavior problems and symptoms of depression at three and twelve months after baseline. (2) TEP caregivers will experience a significant increase in dementia management skills and feelings of caregiver competence and mastering and a significant decrease in caregiver hassles at three and twelve months after baseline. (3) TEP veterans will experience significantly more days in the community and fewer hospital admissions, inpatient bed days of care, nursing home admissions, and nursing home bed days of care one year after baseline. To test the hypothesis, outcome variables will be analyzed using random effects regression models and survival analysis.
| Condition | Treatment or Intervention |
|---|---|
| Dementia | Behavior: educational program, by telephone |
MedlinePlus related topics: Dementia
Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Expected Total Enrollment: 160
Study start: March 2004; Expected completion: February 2007
Eligibility
Genders Eligible for Study: Both
Accepts Healthy Volunteers
Criteria
- Spouse of veteran
Location and Contact Information
New York
VA Health Care Network Upstate New York, Albany, New York, 12208, United States; Recruiting
Mollie Shulan, MD, Principal Investigator
VA Western New York Health Care System, Buffalo, Buffalo, New York, 14215, United States; Recruiting
Laura Wray, PhD, Sub-Investigator
More Information
Record last reviewed: March 2005
Last Updated: March 16, 2005
Record first received: March 16, 2005
ClinicalTrials.gov Identifier: NCT00105638
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- 2001-2002 Alzheimer’s Disease Progress Report (Alzheimer's Disease Education and Referral Center, NIA, NIH, HHS)
- AIDS - Neurological Complications (National Institute of Neurological Disorders and Stroke)

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