Back to resultsLifeZig Personalized Reminiscence Video With Slideshows and Music for Individuals With Alzheimer's and Dementia (Lifezig)
Primary Purpose
Alzheimer's Disease, Dementia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lifezig
Sponsored by
About this trial
This is an interventional supportive care trial for Alzheimer's Disease
Eligibility Criteria
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.
Sites / Locations
- Photozig, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Lifezig
Usual Care
Arm Description
Subjects watch personalized reminiscence video channels developed by program staff with the help of family members/caregivers (using the LifeZig system)
Subjects follow routine activities applied by nurses or caregivers, such as traditional reminiscence, crafts, singing, recreational activities, and other activities.
Outcomes
Primary Outcome Measures
Multidimensional Observation Scale for Elderly Subject
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of dementia patients, related to patient functioning, disoriented behavior, depression/anxiety, irritable behavior, and withdrawn behavior, consisting of 32 items, divided in four sub-scales: "Personal Care", "Communication, Awareness & Memory", "Mood", and "Interpersonal Awareness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.
Secondary Outcome Measures
Revised Memory and Behavior Problems Checklist
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.
Center for Epidemiologic Studies Depression Scale
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00759863
Brief Title
LifeZig Personalized Reminiscence Video With Slideshows and Music for Individuals With Alzheimer's and Dementia
Acronym
Lifezig
Official Title
LifeZig System for Individuals With Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Photozig, Inc.
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
This program creates personalized TV channels with old photographs of AD patients, music, narration and relaxing sounds; as an activity to relax dementia patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Dementia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
242 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lifezig
Arm Type
Experimental
Arm Description
Subjects watch personalized reminiscence video channels developed by program staff with the help of family members/caregivers (using the LifeZig system)
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Subjects follow routine activities applied by nurses or caregivers, such as traditional reminiscence, crafts, singing, recreational activities, and other activities.
Intervention Type
Behavioral
Intervention Name(s)
Lifezig
Other Intervention Name(s)
LifeZig Personalized Reminiscence Slideshow
Intervention Description
Personalized Reminiscence Video
Primary Outcome Measure Information:
Title
Multidimensional Observation Scale for Elderly Subject
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Revised Memory and Behavior Problems Checklist
Description
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.
Time Frame
6 months
Title
Center for Epidemiologic Studies Depression Scale
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Kajiyama, MS
Organizational Affiliation
Photozig, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Photozig, Inc.
City
Moffett Field
State/Province
California
ZIP/Postal Code
94035-0128
Country
United States
12. IPD Sharing Statement
Learn more about this trial
LifeZig Personalized Reminiscence Video With Slideshows and Music for Individuals With Alzheimer's and Dementia
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