- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00759863
LifeZig Personalized Reminiscence Video With Slideshows and Music for Individuals With Alzheimer's and Dementia (Lifezig)
LifeZig System for Individuals With Alzheimer's Disease
The LifeZig Project is a research study of a new reminiscence activity for individuals with Alzheimer's Disease (AD) and other types of dementia, based on the LifeZig system, with personalized video channels containing old photographs and music on television.
The goal of the LifeZig study is to enhance the quality of life for dementia patients and their families/caregivers, decrease the burden of care, and contribute to positive interaction between dementia patients and families/caregivers.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Moffett Field, California, United States, 94035-0128
- Photozig, Inc.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Inclusion criteria for dementia patients:
- documented diagnosis of probable Alzheimer's or other type of dementia, medically stable, and visual/hearing capabilities to watch television.
Inclusion criteria for family members/caregivers:
- provide care or be a family member of dementia patient, have knowledge of the person, and be able to provide old photographs of dementia patient.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lifezig
Subjects watch personalized reminiscence video channels developed by program staff with the help of family members/caregivers (using the LifeZig system)
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Personalized Reminiscence Video
Other Names:
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No Intervention: Usual Care
Subjects follow routine activities applied by nurses or caregivers, such as traditional reminiscence, crafts, singing, recreational activities, and other activities.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Multidimensional Observation Scale for Elderly Subject
Time Frame: 6 months
|
This scale reflects the overall well-being of dementia patients.
The construct being assessed is the quality of life of dementia patients, related to patient functioning, disoriented behavior, depression/anxiety, irritable behavior, and withdrawn behavior, consisting of 32 items, divided in four sub-scales: "Personal Care", "Communication, Awareness & Memory", "Mood", and "Interpersonal Awareness Behaviors".
The overall score provides an indication of the overall perceived well-being of the dementia patient.
Best value = 32.
Worst Value = 144.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Revised Memory and Behavior Problems Checklist
Time Frame: 6 months
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This scale measures the type/number of dementia patients disturbing behaviors, and how much they bother caregivers with 24 items describing possible troublesome behaviors that the patient might evidence in the past month.
Caregivers are first asked whether the dementia patient had displayed any of these in the time period, and secondly to rate on a 5-point scale (0=not at all; 4= extremely) how much this "bothered or upset" them.
A "conditional bother" score is calculated which is the "upset" or "bother" ratings for only the problematic behavior that occurred.
Best value = 0. Worst Value = 96.
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6 months
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Center for Epidemiologic Studies Depression Scale
Time Frame: 6 months
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The Center for Epidemiological Studies Depression scale (CES-D) is a 20-item measure that asks about the frequency of depressive symptoms (affective, psychological, and somatic) within the past week.
The construct being assessed is the caregiver depression.
Best value = 0. Worst Value = 60.
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6 months
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Collaborators and Investigators
Sponsor
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
- Pz-A102b
- R44AG022261 (U.S. NIH Grant/Contract)
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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