An interventional study of Brain CareNotes Latino and Dementia Care app in Caregiver Burden of People With Dementia, sponsored by Indiana University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Indiana University · Not applicable, Interventional, and Supportive care
Among 10 studies in Caregiver Burden by Indiana University — 3 open to participants now, 4 under way, none of them phase 3. Caregiver Burden · Indiana University.
Among the 10 studies in Caregiver Burden by Indiana University, this one is the 4th largest by planned enrollment, is the only one that started in 2027, is one of 10 with no phase, and was the 10th registered.
500 studies on the registry are indexed under Caregiver Burden; 164 are open to participants now.
Browse Caregiver Burden studies →3 of the 10 studies in Caregiver Burden by Indiana University are open now, in 1 country. Recruiting first, the newest first:
Indiana University · Sites in United States
Indiana University · Sites in United States
By country, each count listing its studies:
Of the 88 Caregiver Burden studies recruiting now, 67 (76%) set no upper age limit and 7 (8%) stop at 75 or younger; 8 take children under 18; 38 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
First in 2018; this study’s year is marked. 1 started in 2027.
This study's planned enrollment of 60 is below the median of 71 across 402 interventional studies indexed under Caregiver Burden.
Median enrollment 60 across the 10 interventional studies. Of the 6 that completed or were terminated, 1 (17%) have results posted.
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Indiana University is the lead sponsor of 986 studies on the registry; 198 are open to participants now.
Of its 148 completed or terminated interventional studies of FDA-regulated products, 118 (80%) have results posted.
2 of the studies in Caregiver Burden by Indiana University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06099197Indiana UniversityI-CARE 2: Mobile Telehealth to Reduce Alzheimer'S-related Symptoms in Hispanic Individuals | 2026-11 |
| NCT05733520Indiana UniversityI-CARE 2: Mobile Telehealth to Reduce Alzheimer'S-related Symptoms | 2027-07-30 |
Among the 10 studies in Caregiver Burden by Indiana University, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The goal of this clinical trial is to evaluate usability, feasibility and preliminary efficacy of a mobile telehealth supported behavioral intervention for caregivers of persons with dementia who identify as Hispanic. The main question it aims to answer is: "is a mobile telehealth supported behavioral intervention aimed at supporting caregivers in managing behavioral and psychological symptoms of dementia (BPSD) usable and acceptable and can it preliminarily reduce depressive symptoms and caregiver burden after 6 months of exposure?
Hypothesis: The mobile/telehealth supported intervention will be feasible, as indicated by recruitment and retention rates, data completion, and usability and acceptance measures.
Exploratory Hypothesis: The mobile/telehealth supported intervention will improve caregiver burden and reduce BPSD as measured by the Neuropsychiatric Inventory (NPI-Q).
Researchers will compare an intervention group to a control group to see if there are differences in preliminary outcomes.
Participants will communicate with care coaches through the app and through individualized remotely delivered sessions. The app generates advice cards to develop a care plan that addresses behavioral and psychological symptoms of dementia (BPSD), and tracks cognitive, functional, behavioral and psychological symptoms of the patient and informal caregiver participant's health and quality of life. Individual care coach sessions will focus on management of BPSD and caregiver burden.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- Caregivers of individuals with non-dementia related disease.
This arm will include participants receiving the intervention
Behavioral: Brain CareNotes Latino
Control groups will receive an information only app
Other: Dementia Care app
This is a mobile app supported behavioral intervention. Caregivers/ participants will communicate with care coaches through the app and through individualized remotely delivered sessions. The app generates advice cards to develop a care plan that addresses behavioral and psychological symptoms of dementia (BPSD), and tracks cognitive, functional, behavioral and psychological symptoms of the patient and informal caregiver participant's health and quality of life. Individual care coach sessions will focus on management of BPSD and caregiver burden.
Information only app that is freely available in the app store and provides information on dementia care.
Feasibility of the intervention will be measured by recruitment rate
recruitment rate will be calculated by calculating No. approached, No. agreeing, No. consenting, and No. consenting/No. approached.
Time frame: After 6 months participation completed.
Data completion
Data completion will be collected continually and computed after the final assessment by calculating No. of complete caregiver burden and BPSD assessments per consenting participant/total No. of possible assessments. We will separately compute missing data and attrition for all causes vs. death in the intervention vs. control groups. An enrollment and completion rate of 80% will be considered evidence for successful feasibility.
Time frame: After 6 month participation.
System Usability Scale (SUS)
The System Usability Scale (SUS) is a 10-item questionnaire scored on a 5-point Likert scale (1 = "Strongly Disagree" to 5 = "Strongly Agree"). Total administration time is 1-2 minutes. The total score range is 0 to 100 ( calculated using a specific scoring formula, not a simple percentage). Identified benchmarks will include mean SUS scores of 68 and above. English and Spanish versions of the SUS will be administered to measure usability
Time frame: The SUS will be administered at baseline, 3 and 6 month follow up appointment.
Accessibility of Intervention Measure (AIM)
The Acceptability of Intervention Measure (AIM) (developed by Weiner et al., 2017) consists of 4 items rated on a 5-point Likert scale (1 = "Completely Disagree" to 5 = "Completely Agree"). Total administration time is 1-2 minutes. Average score of1 to 5 is calculated by averaging all 4 items. Summed total score range is 4 to 20 (calculated by adding all 4 items together). Higher scores indicate greater intervention acceptability. English and Spanish versions of the AIM will be administered.
Time frame: Baseline, 3 and 6 month follow up appointment.
Caregiver burden and patient BPSD severity will be measured by the Neuropsychiatric Inventory Questionnaire (NPI-Q)
The Neuropsychiatric Inventory Questionnaire (NPI-Q) is a brief clinical measurement filled out by a caregiver to assess behavioral and psychological symptoms in dementia across 12 domains (e.g., agitation, depression, anxiety, apathy, delusions, hallucinations). It takes about 5-10 minutes to complete. Symptom severity score ranges from 0-36 and the caregiver distress score ranges for 0-60. Higher scores indicate greater behavioral severity and heavier caregiver burden.
Time frame: To be collected at baseline, 3 and 6 month follow up.
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Mar 2027; primary completion for Aug 2028, 17 months later.
Of 282 non-industry interventional studies with no phase under Caregiver Burden, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 31. This study's planned 17 months is close to that.
Counting every sponsor, half of 291 studies reached it within 16 months; a quarter within 7 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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