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Completed

NCT Number: NCT03119259

Technology Intervention to Support Caregiving for Alzheimer's Disease (I-CARE)

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.

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Key information

Conditions

Dementia, Alzheimer Type Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eskenazi Health, Indianapolis, Indiana, United States

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About this study

Informal caregivers of patients with Alzheimer's disease and related dementia (ADRD) manage a complex spectrum of patient behavioral and psychological symptoms of dementia (BPSD). BPSD are major contributing factors to caregivers' burden and adverse health outcomes, leading to an increase of unplanned hospitalizations and a decrease in quality of life. The National Alzheimer's Project Act recognizes the need for interventions that "enable family caregivers to continue to provide care while maintaining their own health and well-being." Furthermore, recommendations from 2015 and 2018 Alzheimer's Disease Research Summits include the application of technology to improve caregiving research and ADRD care

This pilot randomized controlled trial, will test the feasibility and estimate the effect size of integrating mobile health technology BrainCare Notes (BCN) into an existing, fully operational, and self-sustaining clinical program (Aging Brain Care; ABC) and IU Health primary care physician clinics (IUHP). BCN is a mobile application (app) for informal caregivers of patients with Alzheimer's Disease and related dementia (ADRD). The BCN app delivers 24/7 psychoeducation and caregiver support, assessment of informal caregiver status and patients' behavioral and psychological symptoms of dementia (BPSD), and engagement tools for self-management and communication. Over a 15 month accrual period, we propose to enroll from the ABC clinical program and IUHP 60 dyads consisting of an adult patient with ADRD and one (primary) informal caregiver. The intervention will continue for 6 months and final assessments will be completed at 6 months. Feasibility data will be collected throughout the study and assessed at the end of the study by computing: (a) recruitment rate; (b) data completion; (c) BCN usability; (d) BCN acceptance; and (e) BCN use. Caregiver burden and patient BPSD will be collected at baseline, 3, and 6 months and evaluated for changes from baseline to 6 months in each group. Means, standard deviations, and confidence intervals will be computed to test feasibility hypotheses. Mixed linear models will be used to test hypotheses comparing the two conditions at 6 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient has received a diagnosis of possible or probable Alzheimer's disease and Related Dementia from a physician in the ABC Clinical Program;
  • Caregiver is at least 18 years of age and does not have a visual impairment significant enough to interfere with his/her ability to use BCN;
  • Both patient and caregiver are community-dwelling in central Indiana; and
  • Both patient and caregiver are willing to participate in the ABC Clinical Program (including receiving home visits).

Exclusion criteria

  • Either the patient or his/her informal caregiver does not have the ability to communicate in English.

Treatment and study plan

ABC Clinical Program

Behavioral

The goal of the ABC Clinical Program is to help primary care physicians achieve the standard of care in the diagnosis, evaluation and management of patients with ADRD. The ABC Clinical Program is delivered by an interdisciplinary team led by a care coordinator. The informal caregiver is also enrolled in the program and caregiver burden is assessed and managed. The ABC team collects all relevant data and formulates an individualized care plan in collaboration with the informal caregiver. The care coordinator communicates the team's recommendations to the primary care physician and finalizes a collaborative plan of action. During the next year, the ABC team uses face-to-face and telephone interactions with the patient and caregiver to monitor and modify implementation of the care plan.

The goal of IUHP Usual Care is to provide preventive care services to their patients. Older adults are assessed for ADRD during clinic visits and refered to brain care specialty as necessary.

Other names: IUHP Usual Care

BCN

Behavioral

BCN is a mobile application (app) for informal caregivers of patients with Alzheimer's Disease and related dementias (ADRD). The BCN app delivers the following behavioral support:

  • 24/7 psychoeducation and caregiver support on a variety of ADRD related topics, presented as a browse-able library of stories and advice cards or "Notes";
  • Assessment of informal caregiver status and patients behavioral and psychological symptoms of dementia (BPSD), in the form of the selfadministered HABC Monitor, along with reporting and historical tracking of HABC Monitor scores;
  • Engagement tools, in particular, (i) a toolkit for saving, sorting, creating/editing, and sharing Notes and (ii) a bi-directional messaging tool for communicating with clinicians or trusted others.

Primary outcomes

  1. Feasibility: Recruitment Rate

    Time frame: 15 month accrual period

    Recruitment rate is the average monthly rate of recruitment into the study, calculated as participants recruited over the accrual period.

  2. Feasibility: Data Completeness

    Time frame: 6 months after enrollment and randomization

    Data completeness is the number of enrolled and randomized individuals who provided data at 3 and 6 months.

  3. Feasibility: BCN Usability (3 Months)

    Time frame: 3 months

    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).

  4. Feasibility: BCN Usability (6 Months)

    Time frame: 6 months

    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.

  5. Feasibility: BCN Acceptance (3 Months)

    Time frame: 3 months

    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.

  6. Feasibility: BCN Acceptance (6 Months)

    Time frame: 6 months

    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).

Secondary outcomes

  1. Caregiver Burden (Baseline)

    Time frame: baseline

    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)

  2. Caregiver Burden (3 Months)

    Time frame: 3 months

    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)

  3. Caregiver Burden (6 Months)

    Time frame: 6 months

    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)

  4. BPSD Severity (Baseline)

    Time frame: baseline

    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).

  5. BPSD Severity (3 Months)

    Time frame: 3 months

    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).

  6. BPSD Severity (6 Months)

    Time frame: 6 months

    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).

  7. Acute Care Utilization (3 Months)

    Time frame: 3 months

    Number of all-cause hospital and emergency room admissions among patients and caregivers in the first 3 months (3 months post-intervention).

  8. Acute Care Utilization (6 Months)

    Time frame: 6 months

    Number of all-cause hospital and emergency room admissions among patients and caregivers in the last 3 months (at 6 months post-intervention).

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: I-CARE

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 18, 2017
Registry last updated
Sep 19, 2024

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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