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NCT Number: NCT07054385

I-CARE Rural Pilot: Intervention for Rural-Dwelling Dementia Caregivers

The purpose of this study is to assess feasibility and to estimate efficacy of our app "Brain CareNotes" for dementia caregivers who reside in a rural setting (as defined by RUCA codes 4 through 10). The Brain CareNotes app is designed to reduce informal caregiver burden of those caring for individuals with Alzheimer's disease and related dementias (ADRD) and behavioral and psychological symptoms of dementia (BPSD) of individuals with ADRD. The study will enroll up to 60 rural caregivers of community-dwelling individuals living with ADRD. Caregivers will be randomized to use the Brain CareNotes app or an attention control education-only app for six months, with usage reminders.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Caregiver Burden Alzheimer Disease Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Stress, Psychological Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University Bloomington

Bloomington, Indiana, 47405, United States

About this study

This study will evaluate the feasibility and estimate the effect of Brain CareNotes on caregiver burden and patient BPSD. The study will enroll up to 60 rural-dwelling caregivers. Participants will be randomized to use the Brain CareNotes app or an attention control education-only app (Dementia Guide Expert) for six months.

The primary objective is to evaluate the feasibility of Brain CareNotes, as assessed by caregiver-reported a) usability, as assessed by the 10-item Simplified System Usability Scale and b) acceptance as assessed by the 4-item Behavioral Intention questionnaire.

The secondary objective is to estimate the effect of Brain CareNotes on a) caregiver burden and b) patient BPSD at six months, compared to attention control. These outcomes are calculated using the caregiver-reported Neuropsychiatric Inventory (NPI): the NPI caregiver distress sub-score measures caregiver burden and the NPI total score measures patient BPSD. The investigators will obtain NPI responses from caregivers at baseline, three, and six months.

Exploratory objectives are to estimate the effect of Brain CareNotes on a) caregiver depressive symptoms and b) patient and caregiver acute care utilization at six months; and to examine early effects at three months on c) the usability and acceptance of Brain CareNotes, and d) caregiver burden and BPSD. Caregiver depressive symptoms will be assessed by the Patient Health Questionnaire-9 (PHQ-9), administered at baseline, three, and six months. Acute care utilization data will be obtained from self-reports to identify both caregivers' and patients' hospital and emergency visits that occurred within six months of enrollment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Self-identified primary unpaid rural (RUCA Code of 4-10) caregiver of a person diagnosed with ADRD (at any stage) who are:
  • Receiving primary care and
  • Community-dwelling;
  • English literate;
  • Age ≥ 18 years

Exclusion criteria

  • 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)

Treatment and study plan

Brain CareNotes

Behavioral

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 Expert

Behavioral

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."

Primary outcomes

  1. App Usability

    Time frame: Six 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.

  2. App Acceptability

    Time frame: Six 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.

Secondary outcomes

  1. Patient BPSD

    Time frame: Six Months

    Behavioral (e.g. agitation, aggression, wandering) and psychological (e.g. delusions, hallucinations) symptoms of dementia as measured by the Neuropsychiatric Inventory (NPI). The NPI is a 12-item questionnaire. The total score is calculated by adding the product of the frequency and severity of those 12 items. A score of 0 would indicate that no symptoms are present while a score of 144 would indicate that all symptoms are present at the highest level of frequency and severity.

  2. Caregiver Burden

    Time frame: Six Months

    The burden experienced by caregivers caused by their caregiving responsibilities measured by the Neuropsychiatric Inventory (NPI) caregiver distress sub-score. The distress score is calculated by adding the distress score for each of the 12 items of the NPI. A score of 0 would indicate that the BPSD cause no distress while a score of 60 would indicate that each symptom causes severe distress for the caregiver.

Other outcomes

  1. Caregiver Depressive Symptoms

    Time frame: Six Months

    Caregiver depression as measured by the Patient Health Questionnaire (PHQ)-9. The PHQ-9 is a 9-item questionnaire using a 0-3 rating scale. Scores range from 0-27. A total score of 0 represents no depression, while score of 5, 10, 15, and 20 serve as cut points for mild, moderate, moderately severe, and severe depression, respectively.

  2. Patient Acute Care Utilization

    Time frame: Six Months

    Patient visits to emergency rooms, hospitals, or inpatient diagnoses. Obtained from caregiver self-reports.

  3. Caregiver Acute Care Utilization

    Time frame: Six Months

    Caregiver visits to emergency rooms, hospitals, or inpatient diagnoses. Obtained from caregiver self-reports.

  4. Caregiver Self-Efficacy

    Time frame: Six Months

    Caregiver perceived self-efficacy as measured using the Revised Scale for Caregiving Self-Efficacy. It consists of 3 sections each with five items. Participants rank self-efficacy on a scale of 0-100 for each item, with a higher score representing greater confidence. Thus, a high total score represents greater self-efficacy.

  5. Caregiver Social Support

    Time frame: Six Months

    Caregiver perceived social support measured using the Multidimensional Scale of Perceived Social Support (MSPSS). The MSPSS is a 12-item questionnaire using a 7-point Likert scale where 1 is very strongly disagree and 7 is very strongly agree. Scores range from 12-84. A low score represents minimal social support while a high score represents a great level of perceived social support.

  6. App Use

    Time frame: Six Months

    Usage logs of app use over time.

Sponsors and collaborators

Lead sponsor

Richard Holden

Other

Registry information

Official study title

I-CARE-Rural Pilot: Remote Digital Intervention for Rural-Dwelling Dementia Caregivers

Acronym: I-CARE-Rural-P

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 8, 2025
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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