Online Caregiver Psychoeducation and Support for Alzheimer's

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00416078
First received: December 22, 2006
Last updated: April 7, 2015
Last verified: April 2015
  Purpose

This study is piloting an internet-based intervention to provide support for caregivers of VA patients with Alzheimer's disease or related memory difficulties (ADRD). Veterans with a clinical diagnosis of ADRD 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 brief telephone calls with project staff for six month. It is hypothesized that participation in the intensive intervention will result in a reductions in patient problematic behavior and caregiver responses to it, reduced caregiver burden and depression, and improved medication adherence at the end of treatment, and more patients remaining at home through the 12 months post-randomization period..


Condition Intervention Phase
Alzheimer's Disease
Behavioral: caregiver website support
Behavioral: caregiver brief supportive phone calls
Phase 2
Phase 3

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:
  • Change in Caregiver Burden From Baseline [ Time Frame: baseline to end-of-treatment (6 months) ] [ Designated as safety issue: No ]
    Total score on the Zarit Short Burden Scale, a 12 item instrument that utilizes a likert scale 1-5 rating of frequency. The range is 12 (never) to 60 (nearly always) wherein higher scores are more indicative of caregiver burden.

  • Change in Frequency of Patient Problematic Behavioral Patterns From Baseline [ Time Frame: baseline to end of treatment (6 months) ] [ Designated as safety issue: No ]
    Total Score on the Frequency of Problematic Behaviors on the Revised Memory and Behavior Problem Checklist. The Revised Memory and Behavior Checklist is a 24 item instrument that measures the frequency of a behavior on a 0-4 likert scale wherein higher numbers indicate greater frequency. The range is 0-96.

  • Change in Caregiver Negative Reactions to Problematic Behavioral Patterns From Baseline [ Time Frame: baseline to end of treatment (6 months) ] [ Designated as safety issue: No ]
    Total Score on the Negative Reactions Scale from the Revised Memory and Behavior Problem Checklist. The scale measures the caregiver's level of reaction to a series of potential problematic behaviors on a 0-4 likert scale; higher numbers indicate a greater degree of distress. The range is 0-96.

  • Change in Caregiver Depression From Baseline [ Time Frame: baseline to end-of-treatment (6 months) ] [ Designated as safety issue: No ]
    Total score on the Beck Depression Inventory. The Beck Depression Inventory is a 21 item likert scale instrument with a total range of 0 to 63. Higher scores are indicative of increased endorsement of depressive symptoms. Additionally, it utilizes a cutoff score of13 to indicate probable depression


Secondary Outcome Measures:
  • Change in Caregiver Report of Patient Medication Adherence From Baseline [ Time Frame: baseline to end-of-treatment (6 months) ] [ Designated as safety issue: No ]
    Adherence to prescribed medication regimen rated by caregiver on a 1 (0%) to 5 (100%) scale. Higher scores indicate better adherence. Values in statistical table below are least square estimates, and thus may be slightly out-of-range of actual respondent choices on scale.


Other Outcome Measures:
  • Number of Participants Placed in Assisted Living or Nursing Homes 12 Months From Baseline [ Time Frame: baseline to end-of-follow-up (12 months from baseline) ] [ Designated as safety issue: No ]
    Frequency count of individuals placed in assisted living or nursing homes


Enrollment: 53
Study Start Date: August 2007
Study Completion Date: December 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: caregiver website support
caregiver access to website support for 6 months embedded in one year of customary care
Behavioral: caregiver website support
caregiver access to website support for 6 months embedded in one year of customary care
Active Comparator: caregiver brief supportive phone calls
caregiver brief supportive telephone calls for 6 months embedded in one year of customary care
Behavioral: caregiver brief supportive phone calls
caregiver brief supportive telephone calls for 6 months embedded in one year of customary care

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 tested an Internet-based family intervention for AD that relatives can access from their homes with ease, and at no cost. In addition to improving patient outcomes through instruction of effective behavioral management, we proposed that participation in an Internet program would also reduce caregiver depression and burden. Fifty-three veterans with a clinical diagnosis of AD and their caregiver/relatives were 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 brief telephone calls with project staff for 6 months. We hypothesized that, at the end of the active intervention, participation in the intensive intervention would result reduced patient problematic behavior, caregiver burden, depression, and negative responses to problematic patient behaviors, as well as improved patient medication compliance. At 12 month follow-up, we hypothesized access to the online program would result in more patients remaining at home. The overriding longterm project objective was 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.

  Eligibility

Ages Eligible for Study:   18 Years to 95 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: December 16, 2014
Last Updated: April 7, 2015
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
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on May 25, 2015