Trial Outcomes & Findings for LifeZig Personalized Reminiscence Video With Slideshows and Music for Individuals With Alzheimer's and Dementia (NCT NCT00759863)
NCT ID: NCT00759863
Last Updated: 2010-03-02
Results Overview
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of dementia patients, related to patient functioning, disoriented behavior, depression/anxiety, irritable behavior, and withdrawn behavior, consisting of 32 items, divided in four sub-scales: "Personal Care", "Communication, Awareness \& Memory", "Mood", and "Interpersonal Awareness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.
COMPLETED
PHASE2
242 participants
6 months
2010-03-02
Participant Flow
Participant milestones
| Measure |
Lifezig
Subjects watch personalized reminiscence video channels developed by program staff with the help of family members/caregivers (using the LifeZig system)
|
Usual Care
Subjects follow routine activities applied by nurses or caregivers, such as traditional reminiscence, crafts, singing, recreational activities, and other activities.
|
|---|---|---|
|
Overall Study
STARTED
|
144
|
98
|
|
Overall Study
COMPLETED
|
124
|
80
|
|
Overall Study
NOT COMPLETED
|
20
|
18
|
Reasons for withdrawal
| Measure |
Lifezig
Subjects watch personalized reminiscence video channels developed by program staff with the help of family members/caregivers (using the LifeZig system)
|
Usual Care
Subjects follow routine activities applied by nurses or caregivers, such as traditional reminiscence, crafts, singing, recreational activities, and other activities.
|
|---|---|---|
|
Overall Study
Death, moved, or lost contact
|
20
|
18
|
Baseline Characteristics
LifeZig Personalized Reminiscence Video With Slideshows and Music for Individuals With Alzheimer's and Dementia
Baseline characteristics by cohort
| Measure |
Lifezig
n=144 Participants
Subjects watch personalized reminiscence video channels developed by program staff with the help of family members/caregivers (using the LifeZig system)
|
Usual Care
n=98 Participants
Subjects follow routine activities applied by nurses or caregivers, such as traditional reminiscence, crafts, singing, recreational activities, and other activities.
|
Total
n=242 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
84.02 years
STANDARD_DEVIATION 7.31 • n=99 Participants
|
84.48 years
STANDARD_DEVIATION 7.03 • n=107 Participants
|
84.21 years
STANDARD_DEVIATION 7.16 • n=206 Participants
|
|
Sex: Female, Male
Female
|
116 Participants
n=99 Participants
|
80 Participants
n=107 Participants
|
196 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
144 participants
n=99 Participants
|
98 participants
n=107 Participants
|
242 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThis 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.
Outcome measures
| Measure |
Lifezig
n=124 Participants
Subjects watch personalized reminiscence video channels developed by program staff with the help of family members/caregivers (using the LifeZig system)
|
Usual Care
n=80 Participants
Subjects follow routine activities applied by nurses or caregivers, such as traditional reminiscence, crafts, singing, recreational activities, and other activities.
|
|---|---|---|
|
Multidimensional Observation Scale for Elderly Subject
|
69.75 Units on a scale
Standard Deviation 19.05
|
77.99 Units on a scale
Standard Deviation 15.17
|
SECONDARY outcome
Timeframe: 6 monthsThis 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.
Outcome measures
| Measure |
Lifezig
n=124 Participants
Subjects watch personalized reminiscence video channels developed by program staff with the help of family members/caregivers (using the LifeZig system)
|
Usual Care
n=80 Participants
Subjects follow routine activities applied by nurses or caregivers, such as traditional reminiscence, crafts, singing, recreational activities, and other activities.
|
|---|---|---|
|
Revised Memory and Behavior Problems Checklist
|
11.39 Units on a scale
Standard Deviation 10.82
|
15.55 Units on a scale
Standard Deviation 11.66
|
SECONDARY outcome
Timeframe: 6 monthsThe 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.
Outcome measures
| Measure |
Lifezig
n=124 Participants
Subjects watch personalized reminiscence video channels developed by program staff with the help of family members/caregivers (using the LifeZig system)
|
Usual Care
n=80 Participants
Subjects follow routine activities applied by nurses or caregivers, such as traditional reminiscence, crafts, singing, recreational activities, and other activities.
|
|---|---|---|
|
Center for Epidemiologic Studies Depression Scale
|
11.00 Units on a scale
Standard Deviation 8.35
|
10.43 Units on a scale
Standard Deviation 8.74
|
Adverse Events
Lifezig
Usual Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place