Online Caregiver Psychoeducation and Support for Alzheimer's
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Purpose
This study is piloting a new internet-based intervention to provide support for caregivers of VA patients with Alzheimer's disease. Veterans with a clinical diagnosis of AD and their caregiver/relatives will be randomized to receive one of two interventions: (1) customary care (cc) and access to an intensive, interactive online education and support website intervention for 6 months, or (2) cc and monthly telephone with project staff. It is hypothesized that participation in the intensive intervention will result in a reduced frequency in patient problematic behavior and a reduction in caregiver depression, burden, and negative responses to problematic patient behaviors.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease |
Behavioral: website intervention Behavioral: supportive telephone calls |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Caregiver Psychoeducation and Support: Improving Outcomes in AD/ADRD |
- Increased community tenure; increased medication compliance [ Time Frame: end-of-treatment (6 months) and end of follow-up (12 months) ] [ Designated as safety issue: No ]
- Decreased family burden; increased family management of problematic behavioral patterns [ Time Frame: end-of-treatment (6 months) and end of follow-up (12 months) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 204 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | December 2013 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
relative access to website support for 6 months embedded in one year of customary care
|
Behavioral: website intervention
6 months weekly online educational and skills building intervention for AD caregivers
Behavioral: supportive telephone calls
brief weekly transitioning to monthly support calls to caregivers of person with AD
|
|
Active Comparator: Arm 2
relative supportive telephone calls for six months embedded in customary care
|
Behavioral: supportive telephone calls
brief weekly transitioning to monthly support calls to caregivers of person with AD
|
Detailed Description:
Alzheimer's disease (AD) is a progressive brain disease resulting in cognitive and functional decline. While some pharmacological agents and behavioral programs are now available to slow the rate of decline, there is no cure. Caregivers, who typically are the female spouses or daughters of afflicted individuals, must confront both the deterioration of a loved one, and that person's need for increasingly demanding care. Caregivers tend to experience high levels of depression, anxiety, and burden. Data suggest that providing education, social support, and ongoing professional consultation to families involved in the care of a relative with AD results in improvement in caregiver psychological status, and sometimes even slows the functional decline of the patient.
Recent technological advancements in video conferencing, online communication, and streaming audio/video presentations, which are increasingly easy to use and gaining widespread acceptance among mental health professionals as well as the public, have given rise to a great deal of interest in telemedicine and telepsychiatry. This study aims to test an Internet-based family intervention for AD that relatives can access from their homes through the world-wide web with ease, and at no cost. In addition to improving patient outcomes through instruction of effective behavioral management, we propose that participation in an Internet program will also reduce caregiver depression and burden. Two hundred four veterans with a clinical diagnosis of AD and their caregiver/relatives are being randomized to receive one of two interventions: (1) customary care (cc) and access to an intensive, interactive online education and support website intervention for 6 months, or (2) cc and monthly telephone with project staff. We hypothesize that participation in the intensive intervention will result in a reduced frequency in patient problematic behavior and a reduction in caregiver depression, burden, and negative responses to problematic patient behaviors. The overriding long-term objective is to develop an effective online education and support program for caregivers of patients with AD that can be manualized, replicated, and disseminated to other clinical and research centers, within both the VA health care system and the community, to enhance the efficiency and effectiveness of psychosocial treatment in AD.
Project recruitment has been completed. Participant feedback about the website (collected at mid and end of the 12 month study period) has been very positive. We are continually updating our website to provide more behavioral management information and access to other resources. One year attrition rates have been low (less than 20%), which is noteworthy for a project with little face to face contact between investigators and participants. We have continued to refine our procedures for providing ongoing technical support to participants, as many are older and have limited experience on the computer and with the internet. We are currently developing a qualitative assessment component of the study so we can more clearly understand issues in caregiving in our population as well as their impression of the website intervention.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient living in community and ambulatory
- Patient has diagnosis of Alzheimer's disease
- Patient age 50-95
- Caregiver age 18-90- Patient currently under treatment for Alzheimer's disease
- Patient and caregiver reside within 2 hours of Los Angeles
- Caregiver has home internet access
- Patient has close contact with caregiver
Exclusion Criteria:
- Patient lives in residential setting
- No family contact
- Acute illness or chronic disease in patient or caregiver
- Patient or caregiver plans to leave area within the year
Contacts and Locations| United States, California | |
| VA Greater Los Angeles Healthcare System, West LA | |
| West Los Angeles, California, United States, 90073 | |
| Principal Investigator: | Theodore J. Hahn, MD | VA Greater Los Angeles Healthcare System, West LA |
More Information
Publications:
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00416078 History of Changes |
| Other Study ID Numbers: | IIR 05-107 |
| Study First Received: | December 22, 2006 |
| Last Updated: | February 12, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
technology development and assessment internet randomized control trial |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 17, 2013