Alzheimer Disease
Conditions
Brief summary
Caring Light is designed to help caregivers of someone with Alzheimer's Disease and related dementia to cope with the difficulties related to caregiving, reduce stress, and improve quality of life.
Detailed description
The goals of this study are to evaluate materials related to dementia caregiving and how to cope with difficult situations faced by caregivers. Based on this research, the investigators are developing the new Caring Light mobile app with a self-paced program to enhance the quality of life, a curriculum that incorporates relaxation techniques, and coping skills training.
Interventions
BEHAVIORALCaring Response App
Participants will receive the Caring Light mobile app containing the coping skills 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 |
|---|---|---|
| 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. |
| 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. |
| 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 |
|---|---|
| Caring Light Training Caring Light mobile app with coping skills training.
Caring Response App: Participants will receive the Caring Light mobile app containing the coping skills training. | 82 |
| Educational Training Traditional educational program.
Traditional Educational/Resources Program: Participants will receive a traditional educational/resources program, containing a workbook and online resources. | 82 |
| Total | 164 |
Baseline characteristics
| Characteristic | Caring Light Training | Educational Training | Total |
|---|---|---|---|
| Age, Continuous | 55.5 years STANDARD_DEVIATION 11.1 | 56.3 years STANDARD_DEVIATION 12 | 55.9 years STANDARD_DEVIATION 11.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 11 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 68 Participants | 71 Participants | 139 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 68 Participants | 70 Participants | 138 Participants |
| Sex: Female, Male Male | 14 Participants | 12 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 82 | 0 / 82 |
| other Total, other adverse events | 0 / 82 | 0 / 82 |
| serious Total, serious adverse events | 0 / 82 | 0 / 82 |
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
Population: Caregivers with full data for the CES-D instrument were included in the outcomes analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caring Light Training | Center for Epidemiological Studies Depression Scale | 17.72 units on a scale | Standard Deviation 10.9 |
| Educational Training | Center for Epidemiological Studies Depression Scale | 21.70 units on a scale | Standard Deviation 9.93 |
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
Population: Caregivers with full data for the Perceived Stress Scale were included in the outcomes analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caring Light Training | Perceived Stress Scale | 17.16 units on a scale | Standard Deviation 7.41 |
| Educational Training | Perceived Stress Scale | 19.36 units on a scale | Standard Deviation 5.82 |
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
Population: Caregivers with full data for the Revised Memory and Behavior Problems Checklist were included in the outcomes analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caring Light Training | Revised Memory and Behavior Problems Checklist | 0.52 units on a scale | Standard Deviation 0.54 |
| Educational Training | Revised Memory and Behavior Problems Checklist | 0.64 units on a scale | Standard Deviation 0.55 |