Alzheimer Disease
Conditions
Brief summary
Our study is designed to help caregivers of someone with Alzheimer's Disease and related dementia to understand and deal with the difficult behaviors of a person with dementia.
Detailed description
The goal of this study is to develop and evaluate the Caring Response mobile app, containing a training that builds skills and stimulates practice. The investigators are evaluating different materials, which may encourage caregiver participation, enable user interaction, and promote better assimilation of concepts. The research team is designing the program to help to enhance caregivers' skills to deal with difficult behaviors, reduce distress, and improve quality of life.
Interventions
BEHAVIORALCaring Response App
Participants will receive the Caring Response mobile app containing the Virtual Patient Behavioral Response Training.
Participants will receive a traditional educational/resources program, containing a workbook and online resources.
Sponsors
Photozig, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Care for an individual with Alzheimer's Disease or other dementia. * Own a smartphone or tablet and have Internet access. * Minimum age of 18 years old. * Spend at least 8 hours/week caring for a person with dementia.
Exclusion criteria
* Severe psychological or physical illness. * Inability to read and follow English instructions. * High level of depressive symptoms. * Unwillingness to participate in all aspects of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Revised Memory and Behavior Problems Checklist | 3 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. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=4. Higher values represent a worse outcome. |
| Center for Epidemiological Studies Depression Scale | 3 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 scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=60. Higher values represent a worse outcome. |
| Perceived Stress Scale | 3 months | The Perceived Stress Scale measures the overall level of stress. This instrument contains 10 items accessing overall appraisals of stress in the past month. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=40. Higher values represent a worse outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Virtual Patient Behavioral Response Training Caring Response mobile app with a behavioral training.
Caring Response App: Participants will receive the Caring Response mobile app containing the Virtual Patient Behavioral Response Training. | 78 |
| Educational Training Traditional educational program.
Traditional Educational/Resources Program: Participants will receive a traditional educational/resources program, containing a workbook and online resources. | 78 |
| Total | 156 |
Baseline characteristics
| Characteristic | Virtual Patient Behavioral Response Training | Educational Training | Total |
|---|---|---|---|
| Age, Continuous | 46.0 years STANDARD_DEVIATION 13.5 | 51.2 years STANDARD_DEVIATION 14.1 | 48.6 years STANDARD_DEVIATION 14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 14 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 74 Participants | 64 Participants | 138 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 60 Participants | 64 Participants | 124 Participants |
| Sex: Female, Male Male | 18 Participants | 14 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 78 | 0 / 78 |
| other Total, other adverse events | 0 / 78 | 0 / 78 |
| serious Total, serious adverse events | 0 / 78 | 0 / 78 |
Outcome results
Primary
Center for Epidemiological 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 scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=60. Higher values represent a worse outcome.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Patient Behavioral Response Training | Center for Epidemiological Studies Depression Scale | 15.84 units on a scale | Standard Deviation 9.97 |
| Educational Training | Center for Epidemiological Studies Depression Scale | 21.00 units on a scale | Standard Deviation 11.76 |
Primary
Perceived Stress Scale
The Perceived Stress Scale measures the overall level of stress. This instrument contains 10 items accessing overall appraisals of stress in the past month. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=40. Higher values represent a worse outcome.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Patient Behavioral Response Training | Perceived Stress Scale | 15.78 units on a scale | Standard Deviation 6.23 |
| Educational Training | Perceived Stress Scale | 19.01 units on a scale | Standard Deviation 7.09 |
Primary
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. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=4. Higher values represent a worse outcome.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Patient Behavioral Response Training | Revised Memory and Behavior Problems Checklist | 0.66 units on a scale | Standard Deviation 0.69 |
| Educational Training | Revised Memory and Behavior Problems Checklist | 0.89 units on a scale | Standard Deviation 0.78 |