Online Caregiver Psychoeducation and Support for Alzheimer's

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00416078
First received: December 22, 2006
Last updated: January 2, 2014
Last verified: December 2013
  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

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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: June 2014
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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00416078

Locations
United States, California
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, United States, 90073
Sponsors and Collaborators
Investigators
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: January 2, 2014
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 April 22, 2014