Clinical trial NCT00416078: Online Caregiver Psychoeducation and Support for Alzheimer's
Official title: Caregiver Psychoeducation and Support: Improving Outcomes in AD/ADRD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Alzheimer's Disease
Keywords: technology development and assessment
internet
randomized control trial
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2006-12-27
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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..

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 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

Primary outcomes:
measure: Change in Caregiver Burden From Baseline
timeFrame: baseline to end-of-treatment (6 months)
measure: Change in Frequency of Patient Problematic Behavioral Patterns From Baseline
timeFrame: baseline to end of treatment (6 months)
measure: Change in Caregiver Negative Reactions to Problematic Behavioral Patterns From Baseline
timeFrame: baseline to end of treatment (6 months)
measure: Change in Caregiver Depression From Baseline
timeFrame: baseline to end-of-treatment (6 months)
Secondary outcomes:
measure: Change in Caregiver Report of Patient Medication Adherence From Baseline
timeFrame: baseline to end-of-treatment (6 months)
Other outcomes:
measure: Number of Participants Placed in Assisted Living or Nursing Homes 12 Months From Baseline
timeFrame: baseline to end-of-follow-up (12 months from baseline)
Locations:
city: West Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System, West LA
state: California
Study officials:
affiliation: VA Greater Los Angeles Healthcare System, West LA
name: Theodore J. Hahn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hayden LJ, Glynn SM, Hahn TJ, Randall F, Randolph E. The use of Internet technology for psychoeducation and support with dementia caregivers. Psychol Serv. 2012 May;9(2):215-8. doi: 10.1037/a0027056.
citation: Gonzalez-Fraile E, Ballesteros J, Rueda JR, Santos-Zorrozua B, Sola I, McCleery J. Remotely delivered information, training and support for informal caregivers of people with dementia. Cochrane Database Syst Rev. 2021 Jan 4;1(1):CD006440. doi: 10.1002/14651858.CD006440.pub3.