N/A
N=53
Technology Intervention to Support Caregiving for Alzheimer's Disease (I-CARE)
Dementia, Alzheimer Type
Bottom Line
View on ClinicalTrials.gov: NCT03119259 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Feasibility: Recruitment Rate — 4.1 participants recruited per month
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ABC Clinical Program (Behavioral); BCN (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility: Recruitment Rate |
4.1 | — |
| PRIMARY Feasibility: Data Completeness |
19; 21; 22; 23 | — |
| PRIMARY Feasibility: BCN Usability (3 Months) |
76.3 | — |
| PRIMARY Feasibility: BCN Usability (6 Months) |
72.5 | — |
| PRIMARY Feasibility: BCN Acceptance (3 Months) |
2 | — |
| PRIMARY Feasibility: BCN Acceptance (6 Months) |
2.0 | — |
| SECONDARY Caregiver Burden (Baseline) |
9.8; 8.5 | — |
| SECONDARY Caregiver Burden (3 Months) |
10.9; 7.5 | — |
| SECONDARY Caregiver Burden (6 Months) |
8.8; 7.8 | — |
| SECONDARY BPSD Severity (Baseline) |
17.2; 16.4 | — |
| SECONDARY BPSD Severity (3 Months) |
18.3; 12.4 | — |
| SECONDARY BPSD Severity (6 Months) |
18.5; 15.9 | — |
| SECONDARY Acute Care Utilization (3 Months) |
7; 13; 5; 6 | — |
| SECONDARY Acute Care Utilization (6 Months) |
3; 13; 5; 3 | — |
Summary
The specific aims of this study are 1) to test the trial and intervention feasibility of Brain Care Notes (BCN) app, 2) To estimate the effect size of BCN on reducing informal caregiver burden at 6 months, and 3) To estimate the effect size of BCN on reducing patient behavioral and psychological symptoms of dementia (BPSD) at 6 months. Subjects will be recruited from the Aging Brain Care (ABC) program of Eskenazi Health and Indiana University Health located in central Indiana.
Eligibility Criteria
Inclusion Criteria
- Patient has received a diagnosis of possible or probable Alzheimer's disease and Related Dementia from a physician in the ABC Clinical Program;
- Caregiver is at least 18 years of age and does not have a visual impairment significant enough to interfere with his/her ability to use BCN;
- Both patient and caregiver are community-dwelling in central Indiana; and
- Both patient and caregiver are willing to participate in the ABC Clinical Program (including receiving home visits).
Exclusion Criteria
- Either the patient or his/her informal caregiver does not have the ability to communicate in English.
Data sourced from ClinicalTrials.gov (NCT03119259). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.