Alzheimer's Disease, Dementia
Conditions
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.
Interventions
BEHAVIORALLifezig
Personalized Reminiscence Video
Sponsors
Photozig, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Multidimensional Observation Scale for Elderly Subject | 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of dementia patients, related to patient functioning, disoriented behavior, depression/anxiety, irritable behavior, and withdrawn behavior, consisting of 32 items, divided in four sub-scales: Personal Care, Communication, Awareness & Memory, Mood, and Interpersonal Awareness Behaviors.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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Revised Memory and Behavior Problems Checklist | 6 months | 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 | 6 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lifezig Subjects watch personalized reminiscence video channels developed by program staff with the help of family members/caregivers (using the LifeZig system) | 144 |
| Usual Care Subjects follow routine activities applied by nurses or caregivers, such as traditional reminiscence, crafts, singing, recreational activities, and other activities. | 98 |
| Total | 242 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death, moved, or lost contact | 20 | 18 |
Baseline characteristics
| Characteristic | Lifezig | Usual Care | Total |
|---|---|---|---|
| Age Continuous | 84.02 years STANDARD_DEVIATION 7.31 | 84.48 years STANDARD_DEVIATION 7.03 | 84.21 years STANDARD_DEVIATION 7.16 |
| Region of Enrollment United States | 144 participants | 98 participants | 242 participants |
| Sex: Female, Male Female | 116 Participants | 80 Participants | 196 Participants |
| Sex: Female, Male Male | 28 Participants | 18 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 144 | 0 / 98 |
| serious Total, serious adverse events | 0 / 144 | 0 / 98 |
Outcome results
Primary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifezig | Multidimensional Observation Scale for Elderly Subject | 69.75 Units on a scale | Standard Deviation 19.05 |
| Usual Care | Multidimensional Observation Scale for Elderly Subject | 77.99 Units on a scale | Standard Deviation 15.17 |
Secondary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifezig | Center for Epidemiologic Studies Depression Scale | 11.00 Units on a scale | Standard Deviation 8.35 |
| Usual Care | Center for Epidemiologic Studies Depression Scale | 10.43 Units on a scale | Standard Deviation 8.74 |
Secondary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifezig | Revised Memory and Behavior Problems Checklist | 11.39 Units on a scale | Standard Deviation 10.82 |
| Usual Care | Revised Memory and Behavior Problems Checklist | 15.55 Units on a scale | Standard Deviation 11.66 |