Caregiver Burden of People With DementiaFAMILIANCT07792889
AIM 3 Focused Adaptation of a Mobile Caregiver Intervention for Dementia Caregivers
A study testing Brain CareNotes Latino and Dementia Care app in people with Caregiver Burden of People With Dementia, run by Indiana University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregiver Burden of People With Dementia
- What is being tested?
- Brain CareNotes Latino and Dementia Care app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Mar 2027to Aug 2028
- 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
- Self-identify as Hispanic/Latino and are informal caregivers of a person with dementia.
- Able to speak or read English or Spanish
- Able to use technology as measured by a technology screening measure.
- Age 18 and older
Who cannot join
- Caregivers of individuals with non-dementia related disease.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: FAMILIA: Focused Adaptation of a Mobile Intervention for Dementia Caregivers
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.
Read more
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.
- Conditions
- Caregiver Burden of People With Dementia
- Being tested
- Brain CareNotes Latino, Dementia Care app
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain CareNotes LatinoBehavioural
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.
Dementia Care appOther
Information only app that is freely available in the app store and provides information on dementia care.
| Study group | Role | What they receive |
|---|---|---|
| Mobile/telehealth supported behavioral intervention | Experimental | This arm will include participants receiving the intervention Receives: Behavioral: Brain CareNotes Latino |
| Control group | Placebo comparator | Control groups will receive an information only app Receives: Other: Dementia Care app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline, 3 and 6 month follow up appointment.
Secondary outcomes (1)
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.
Measured: To be collected at baseline, 3 and 6 month follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study startMar 2027 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver Burden of People With DementiaStudies 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792889
- Sponsor's protocol ID
- 32712
- Other IDs
- K23AG084856
- Acronym
- FAMILIA
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FAMILIA: Focused Adaptation of a Mobile Intervention for Dementia Caregivers
- ClinicalTrials.gov ID
- NCT07792889
- Acronym / sponsor ID
- FAMILIA / 32712
- Conditions
- Caregiver Burden of People With Dementia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Mar 2027 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 28 Aug 2026 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile/telehealth supported behavioral intervention | Experimental | Behavioral: Brain CareNotes LatinoThis arm will include participants receiving the intervention |
| Control group | Placebo comparator | Other: Dementia Care appControl groups will receive an information only app |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Self-identify as Hispanic/Latino and are informal caregivers of a person with dementia.
- Able to speak or read English or Spanish
- Able to use technology as measured by a technology screening measure.
- Age 18 and older
Key exclusion criteria (1 listed)
- Caregivers of individuals with non-dementia related disease.
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 CareNotes LatinoThis 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. | Behavioural | Mobile/telehealth supported behavioral intervention |
| Dementia Care appInformation only app that is freely available in the app store and provides information on dementia care. | Other | Control group |
Primary outcome
Feasibility of the intervention will be measured by recruitment rate
Time frame: After 6 months participation completed.
recruitment rate will be calculated by calculating No. approached, No. agreeing, No. consenting, and No. consenting/No. approached.
Data completion
Time frame: After 6 month participation.
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.
System Usability Scale (SUS)
Time frame: The SUS will be administered at baseline, 3 and 6 month follow up appointment.
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
Accessibility of Intervention Measure (AIM)
Time frame: Baseline, 3 and 6 month follow up appointment.
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.
1 secondary outcome
Caregiver burden and patient BPSD severity will be measured by the Neuropsychiatric Inventory Questionnaire (NPI-Q)
Time frame: To be collected at baseline, 3 and 6 month follow up.
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 28 Aug 2026.
- Individual participant dataSharing planned: No
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Buddy-Up Dyadic Physical Activity Program for Persons With Dementia and Family Caregivers
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Brain CareNotes Latino and Dementia Care app in people with Caregiver Burden of People With Dementia, run by Indiana University.
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 4 inclusion and 1 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: opening soon, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Contact Miriam Rodriguez, PhD (812-856-1661, mijrodri@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the intervention will be measured by recruitment rate (time frame: After 6 months participation completed.). The study lists 4 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 28 Aug 2026.