Caregiver BurdenNCT06099197
I-CARE 2: Mobile Telehealth to Reduce Alzheimer'S-related Symptoms in Hispanic Individuals
A study testing Brain CareNotes and Dementia Guide Expert in people with Caregiver Burden and Alzheimer Disease, run by Indiana University at 1 site in United States.
Trial summary
This study is a randomized, controlled trial (RCT) to evaluate usability and acceptability, and met and unmet needs from a caregiver intervention app, Brain CareNotes, among unpaid Hispanic caregivers of patients with dementia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregiver Burden, Alzheimer Disease
- What is being tested?
- Brain CareNotes and Dementia Guide Expert
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2023to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: I-CARE 2 RCT: Mobile Telehealth to Reduce Alzheimer'S-related Symptoms for Hispanic Caregivers and Patients
This study is a randomized, controlled trial (RCT) to evaluate usability and acceptability, and met and unmet needs from a caregiver intervention app, Brain CareNotes, among unpaid Hispanic caregivers of patients with dementia. Brain CareNotes provides support for management of the behavioral and psychological symptoms of dementia (BPSD) displayed by care recipients. Over 10 months, the trial will enroll 40 Hispanic caregivers of community-dwelling patients diagnosed with Alzheimer's disease or a related dementia (ADRD). Caregivers will be randomized to use the Brain CareNotes app or an attention control education-only app for 12 months, with usage reminders.
Read the detailed description
This study is a hybrid efficacy-effectiveness RCT to evaluate usability and acceptability, and met and unmet needs from a caregiver intervention app, Brain CareNotes. Over 10 months, the trial will enroll 40 Hispanic caregivers. Participants will be randomized to use the Brain CareNotes app or an attention control education-only app (Dementia Guide Expert) for 12 months.
The primary objective is to test the the usability and acceptability, as well as needs met and unmet by Brain CareNotes among Hispanic caregivers of persons with dementia. Barriers in access and acceptance of dementia care resources have been previously identified including gaps in understanding of beliefs or practices between patients and local health systems, low health literacy, language barriers, and other cultural factors. These barriers may affect usability and acceptance of interventions. Therefore, it is hypothesized that average scores on the Simplified Systems Usability Scale will be less than 70 and low acceptance rates will be reported by more than 70% of the Hispanic co-hort. These measures will be administered at 3, 6 and 12 months.
The secondary objective is to examine the needs of Hispanic caregivers that are met and unmet by the Brain CareNotes intervention. Information on how unique culturally influenced needs were met or not met by Brain CareNotes will be collected and suggestions for changes to the intervention app will be identified. This aim will be addressed qualitatively by providing semi-structured interviews guided by the PROGRESS-PLUS framework to the Hispanic participants who received the Brain CareNotes intervention (n=20) about their experience with the intervention and suggestions for changes. The PROGRESS-PLUS framework addresses cultural and socio-economic factors that should be considered when creating behavioral interventions that are culturally compatible. It is expected that responses to interviews will identify themes consistent with a lack of cultural compatibility to factors identified by the PROGRESS-PLUS framework.
- Conditions
- Caregiver Burden, Alzheimer Disease
- Being tested
- Brain CareNotes, Dementia Guide Expert
- Keywords
- Alzheimer's disease and related dementias, Hispanic caregivers, Caregiver Burden, Behavioral and psychological symptoms of dementia
- Medical subject headings
- Caregiver Burden, Alzheimer Disease, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain CareNotesBehavioural
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.
Dementia Guide ExpertBehavioural
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."
| Study group | Role | What they receive |
|---|---|---|
| Brain CareNotes | Experimental | 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. Receives: Behavioral: Brain CareNotes |
| Attention Control App | Active comparator | 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." Receives: Behavioral: Dementia Guide Expert |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Usability Scale
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.
Measured: 3 months, 6 months,12 months
Behavioral Intention Questionnaire
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.
Measured: 3 months, 6 months, 12 months
Secondary outcomes (1)
Qualitative Interview
Participants in the intervention group will complete semi-structured interviews guided by the PROGRESS-PLUS framework. The purpose of these interviews will be to determine their needs that were met or not met by the study intervention.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start26 Sep 2023
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver BurdenStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to receive the Brain CareNotes app or an attention control app.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Miriam J Rodriguez, Indiana University
- Investigators
- Richard J Holden, PhD, Principal investigator, Indiana UniversityMalaz Boustani, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099197
- Sponsor's protocol ID
- 20311
- Other IDs
- R01AG078234
- Status last verified
- Aug 2026
- First submitted
- 19 Oct 2023
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- I-CARE 2 RCT: Mobile Telehealth to Reduce Alzheimer'S-related Symptoms for Hispanic Caregivers and Patients
- ClinicalTrials.gov ID
- NCT06099197
- Acronym / sponsor ID
- 20311
- Conditions
- Caregiver Burden, Alzheimer Disease
- Keywords
- Alzheimer's disease and related dementias, Hispanic caregivers, Caregiver Burden, Behavioral and psychological symptoms of dementia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 26 Sep 2023 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 25 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized, controlled trial (RCT) to evaluate usability and acceptability, and met and unmet needs from a caregiver intervention app, Brain CareNotes, among unpaid Hispanic caregivers of patients with dementia. Brain CareNotes provides support for management of the behavioral and psychological symptoms of dementia (BPSD) displayed by care recipients. Over 10 months, the trial will enroll 40 Hispanic caregivers of community-dwelling patients diagnosed with Alzheimer's disease or a related dementia (ADRD). Caregivers will be randomized to use the Brain CareNotes app or an attention control education-only app for 12 months, with usage reminders.
Detailed description
This study is a hybrid efficacy-effectiveness RCT to evaluate usability and acceptability, and met and unmet needs from a caregiver intervention app, Brain CareNotes. Over 10 months, the trial will enroll 40 Hispanic caregivers. Participants will be randomized to use the Brain CareNotes app or an attention control education-only app (Dementia Guide Expert) for 12 months.
The primary objective is to test the the usability and acceptability, as well as needs met and unmet by Brain CareNotes among Hispanic caregivers of persons with dementia. Barriers in access and acceptance of dementia care resources have been previously identified including gaps in understanding of beliefs or practices between patients and local health systems, low health literacy, language barriers, and other cultural factors. These barriers may affect usability and acceptance of interventions. Therefore, it is hypothesized that average scores on the Simplified Systems Usability Scale will be less than 70 and low acceptance rates will be reported by more than 70% of the Hispanic co-hort. These measures will be administered at 3, 6 and 12 months.
The secondary objective is to examine the needs of Hispanic caregivers that are met and unmet by the Brain CareNotes intervention. Information on how unique culturally influenced needs were met or not met by Brain CareNotes will be collected and suggestions for changes to the intervention app will be identified. This aim will be addressed qualitatively by providing semi-structured interviews guided by the PROGRESS-PLUS framework to the Hispanic participants who received the Brain CareNotes intervention (n=20) about their experience with the intervention and suggestions for changes. The PROGRESS-PLUS framework addresses cultural and socio-economic factors that should be considered when creating behavioral interventions that are culturally compatible. It is expected that responses to interviews will identify themes consistent with a lack of cultural compatibility to factors identified by the PROGRESS-PLUS framework.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to receive the Brain CareNotes app or an attention control app.
| Arm | Type | Receives |
|---|---|---|
| Brain CareNotes | Experimental | Behavioral: Brain CareNotesThe 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. |
| Attention Control App | Active comparator | Behavioral: Dementia Guide ExpertDementia 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." |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain CareNotesThe 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. | Behavioural | Brain CareNotes |
| Dementia Guide ExpertDementia 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." | Behavioural | Attention Control App |
Primary outcome
System Usability Scale
Time frame: 3 months, 6 months,12 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.
Behavioral Intention Questionnaire
Time frame: 3 months, 6 months, 12 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.
1 secondary outcome
Qualitative Interview
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard J Holden, PhD principal investigator
Indiana University
Malaz Boustani, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain CareNotes and Dementia Guide Expert in people with Caregiver Burden and Alzheimer Disease, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Scale (time frame: 3 months, 6 months,12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.