Last reviewed · How we verify
Technology Intervention to Support Caregiving for Alzheimer's Disease (I-CARE)
NA trial testing ABC Clinical Program in Dementia, Alzheimer Type in 53 participants. Completed in 31 July 2021.
| Lead sponsor | Indiana University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | health services research |
| Enrollment | 53 |
| Start date | 25 November 2019 |
| Primary completion | 31 July 2021 |
| Estimated completion | 31 July 2021 |
| Sites | 2 locations across United States |
Indiana University
18 and older, any sex, with Dementia, Alzheimer Type. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Recruitment rate is the average monthly rate of recruitment into the study, calculated as participants recruited over the accrual period.
| Group | Value | 95% CI |
|---|---|---|
| All Participants | 4.1 | ± 4.1 |
Data completeness is the number of enrolled and randomized individuals who provided data at 3 and 6 months.
| Group | Value | 95% CI |
|---|---|---|
| Usual Care | 19 | |
| Brain CareNotes (BCN) Software | 21 |
| Group | Value | 95% CI |
|---|---|---|
| Usual Care | 22 | |
| Brain CareNotes (BCN) Software | 23 |
BCN usability at 3 months is the summary score on the modified System Usability Scale (SUS) 10-item scale instrument, ranging from 0 (worst outcome) to 100 (best outcome).
| Group | Value | 95% CI |
|---|---|---|
| Brain CareNotes (BCN) Software App | 76.3 | 66.3 – 83.8 |
BCN usability at 6 months is the summary score on the modified System Usability Scale (SUS) 10-item scale instrument, ranging from 0 to 100. Higher scores indicate higher usability.
| Group | Value | 95% CI |
|---|---|---|
| Brain CareNotes (BCN) Software App | 72.5 | 70 – 90 |
Acceptance at 3 months is the mean score on the Behavioral Intention 4-item scale on a 7-point response scale from 0 (not at all) to 6 (a great deal). Higher scores indicate higher acceptance.
| Group | Value | 95% CI |
|---|---|---|
| Brain CareNotes (BCN) Software App | 2 | 1.5 – 4.0 |
Acceptance at 6 months is the mean score on the Behavioral Intention 4-item scale on a 7-point response scale from 0 (not at all) to 6 (a great deal).
| Group | Value | 95% CI |
|---|---|---|
| Brain CareNotes (BCN) Software App | 2.0 | 1.0 – 3.0 |
Informal caregiver burden at baseline, assessed by calculating the NPI-Caregiver Distress score (possible range from 0, best outcome, to 60, worst outcome) from the researcher administered Neuropsychiatric Inventory (NPI)
| Group | Value | 95% CI |
|---|---|---|
| Usual Care | 9.8 | ± 7.4 |
| Brain CareNotes (BCN) Software | 8.5 | ± 6.3 |
Informal caregiver burden at 3 months, assessed by calculating the NPI-Caregiver Distress score (possible range from 0, best outcome, to 60, worst outcome) from the researcher administered Neuropsychiatric Inventory (NPI)
| Group | Value | 95% CI |
|---|---|---|
| Usual Care | 10.9 | ± 8.2 |
| Brain CareNotes (BCN) Software | 7.5 | ± 6.8 |
Informal caregiver burden at 6 months, assessed by calculating the NPI-Caregiver Distress score (possible range from 0, best outcome, to 60, worst outcome) from the researcher administered Neuropsychiatric Inventory (NPI)
| Group | Value | 95% CI |
|---|---|---|
| Usual Care | 8.8 | ± 7.0 |
| Brain CareNotes (BCN) Software | 7.8 | ± 6.2 |
Severity of patient behavioral and psychological symptoms of dementia (BPSD) at baseline, assessed by calculating the NPI total score (possible range from 0, best outcome, to 144, worst outcome) from caregiver-reported responses to the researcher-administered Neuropsychiatric Inventory (NPI).
| Group | Value | 95% CI |
|---|---|---|
| Usual Care | 17.2 | ± 15.5 |
| Brain CareNotes (BCN) Software | 16.4 | ± 13.4 |
Severity of patient behavioral and psychological symptoms of dementia (BPSD) at 3 months, assessed by calculating the NPI total score (possible range from 0, best outcome, to 144, worst outcome) from caregiver-reported responses to the researcher-administered Neuropsychiatric Inventory (NPI).
| Group | Value | 95% CI |
|---|---|---|
| Usual Care | 18.3 | ± 15.1 |
| Brain CareNotes (BCN) Software | 12.4 | ± 11.0 |
Severity of patient behavioral and psychological symptoms of dementia (BPSD) at 6 months, assessed by calculating the NPI total score (possible range from 0, best outcome, to 144, worst outcome) from caregiver-reported responses to the researcher-administered Neuropsychiatric Inventory (NPI).
| Group | Value | 95% CI |
|---|---|---|
| Usual Care | 18.5 | ± 16.0 |
| Brain CareNotes (BCN) Software | 15.9 | ± 12.9 |
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.
4 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03119259.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing