Alzheimer Disease, Caregiver Burden
Conditions
Keywords
Alzheimer disease and related dementias, Caregiver, Caregiver Burden, Behavioral and psychological symptoms of dementia, Rural
Brief summary
The purpose of this study is to assess feasibility and to estimate efficacy of our app "Brain CareNotes" for dementia caregivers who reside in a rural setting (as defined by RUCA codes 4 through 10). The Brain CareNotes app is designed to reduce informal caregiver burden of those caring for individuals with Alzheimer's disease and related dementias (ADRD) and behavioral and psychological symptoms of dementia (BPSD) of individuals with ADRD. The study will enroll up to 60 rural caregivers of community-dwelling individuals living with ADRD. Caregivers will be randomized to use the Brain CareNotes app or an attention control education-only app for six months, with usage reminders.
Detailed description
This study will evaluate the feasibility and estimate the effect of Brain CareNotes on caregiver burden and patient BPSD. The study will enroll up to 60 rural-dwelling caregivers. Participants will be randomized to use the Brain CareNotes app or an attention control education-only app (Dementia Guide Expert) for six months. The primary objective is to evaluate the feasibility of Brain CareNotes, as assessed by caregiver-reported a) usability, as assessed by the 10-item Simplified System Usability Scale and b) acceptance as assessed by the 4-item Behavioral Intention questionnaire. The secondary objective is to estimate the effect of Brain CareNotes on a) caregiver burden and b) patient BPSD at six months, compared to attention control. These outcomes are calculated using the caregiver-reported Neuropsychiatric Inventory (NPI): the NPI caregiver distress sub-score measures caregiver burden and the NPI total score measures patient BPSD. The investigators will obtain NPI responses from caregivers at baseline, three, and six months. Exploratory objectives are to estimate the effect of Brain CareNotes on a) caregiver depressive symptoms and b) patient and caregiver acute care utilization at six months; and to examine early effects at three months on c) the usability and acceptance of Brain CareNotes, and d) caregiver burden and BPSD. Caregiver depressive symptoms will be assessed by the Patient Health Questionnaire-9 (PHQ-9), administered at baseline, three, and six months. Acute care utilization data will be obtained from self-reports to identify both caregivers' and patients' hospital and emergency visits that occurred within six months of enrollment.
Interventions
BEHAVIORALBrain CareNotes
The Brain CareNotes mobile telehealth app is used by unpaid caregivers for BPSD management. It includes remote communication with an external human support person-a care coach-as well as features for users to independently perform health-related activities.
BEHAVIORALDementia Guide Expert
Dementia Guide Expert provides education only and no interactive BPSD management support, coaching, assessment, or external response. It contains "evidence-based expert information on what dementia is, types, contributing factors, risks, symptoms, stages, diagnosis, tests, treatment, management, communication techniques, and links to resources and support services."
Sponsors
Richard Holden
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The participant, primary investigator and outcome assessor will be masked to the app assignment (Brain CareNotes vs Attention Control App). The participant will be aware of the treatment received but is masked to whether the app they are assigned is the intervention versus control.
Intervention model description
Participants will be randomized to receive the Brain CareNotes app or an attention control app.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Self-identified primary unpaid rural (RUCA Code of 4-10) caregiver of a person diagnosed with ADRD (at any stage) who are: * Receiving primary care and * Community-dwelling; * English literate; * Age ≥ 18 years
Exclusion criteria
* Care recipient is a permanent resident of an extended care facility (nursing home); * Involvement in another clinical trial that would prevent or interfere with study objectives; * Sensory or other impairment prohibiting the use of a mobile touchscreen device or other study activity (after correction)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| App Usability | Six Months | 10-item standardized survey of user-reported technology usability, based on revised System Usability Scale, with scale score computed ranging from 0-100, with 100 indicating highest possible perceived usability. |
| App Acceptability | Six Months | A 4-item questionnaire assessing a user's intention to use a technology in the near future. Scores range from 0-24 with a high score representing greater intention to use the technology. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient BPSD | Six Months | Behavioral (e.g. agitation, aggression, wandering) and psychological (e.g. delusions, hallucinations) symptoms of dementia as measured by the Neuropsychiatric Inventory (NPI). The NPI is a 12-item questionnaire. The total score is calculated by adding the product of the frequency and severity of those 12 items. A score of 0 would indicate that no symptoms are present while a score of 144 would indicate that all symptoms are present at the highest level of frequency and severity. |
| Caregiver Burden | Six Months | The burden experienced by caregivers caused by their caregiving responsibilities measured by the Neuropsychiatric Inventory (NPI) caregiver distress sub-score. The distress score is calculated by adding the distress score for each of the 12 items of the NPI. A score of 0 would indicate that the BPSD cause no distress while a score of 60 would indicate that each symptom causes severe distress for the caregiver. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJordan R Hill, PhD
Indiana University, Bloomington
PRINCIPAL_INVESTIGATORRichard J Holden, PhD
Indiana University, Bloomington
Outcome results
None listed