- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00416078
Online Caregiver Psychoeducation and Support for Alzheimer's
Caregiver Psychoeducation and Support: Improving Outcomes in AD/ADRD
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
California
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West Los Angeles, California, United States, 90073
- VA Greater Los Angeles Healthcare System, West LA
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: caregiver website support
caregiver access to website support for 6 months embedded in one year of customary care
|
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
|
caregiver brief supportive telephone calls for 6 months embedded in one year of customary care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Caregiver Burden From Baseline
Time Frame: baseline to end-of-treatment (6 months)
|
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.
|
baseline to end-of-treatment (6 months)
|
Change in Frequency of Patient Problematic Behavioral Patterns From Baseline
Time Frame: baseline to end of treatment (6 months)
|
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.
|
baseline to end of treatment (6 months)
|
Change in Caregiver Negative Reactions to Problematic Behavioral Patterns From Baseline
Time Frame: baseline to end of treatment (6 months)
|
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.
|
baseline to end of treatment (6 months)
|
Change in Caregiver Depression From Baseline
Time Frame: baseline to end-of-treatment (6 months)
|
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
|
baseline to end-of-treatment (6 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Caregiver Report of Patient Medication Adherence From Baseline
Time Frame: baseline to end-of-treatment (6 months)
|
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.
|
baseline to end-of-treatment (6 months)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Frequency count of individuals placed in assisted living or nursing homes
|
baseline to end-of-follow-up (12 months from baseline)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Theodore J. Hahn, MD, VA Greater Los Angeles Healthcare System, West LA
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIR 05-107
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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