- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03119259
Technology Intervention to Support Caregiving for Alzheimer's Disease (I-CARE) (I-CARE)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Indiana
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Indianapolis, Indiana, United States, 46202
- IU Health
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Indianapolis, Indiana, United States, 46202
- Eskenazi Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ABC Clinical Program Only and Usual Care
Patients and informal caregivers randomized to the comparison group will receive care provided by the ABC Clinical Program and IUHP.
The ABC Clinical Program is the standard of ADRD care at Eskenazi Health and Primary Care Visits at Indiana University Health is the usual care.
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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:
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Experimental: BCN Mobile App Plus ABC and BCN Mobile app only
Patients and caregivers randomized to the intervention group will continue to receive care in ABC clinical program and IUHP, and have the BCN software installed on either the caregiver's personal mobile device (assuming it meets minimal technical requirements) or a device provided by the study, per participant preference.
A research assistant will orient participants to the device, provide training on the BCN software, and troubleshoot technical issues.
Participants will receive daytime technical support by phone, electronic support request through a separate app, or printed and in-app help manuals.
Hardware, software, and connectivity check-ups will be provided by study research personnel.
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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:
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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility: Recruitment rate
Time Frame: 15 month accrual period
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Recruitment rate will be collected continually and computed at the end of the accrual period by calculating # approached, # agreeing, # consenting, and # consenting / # approached.
We will also calculate the monthly rate.
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15 month accrual period
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Feasibility: Data completeness
Time Frame: 21 month outcome assessment period
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Data completion will be collected continually and computed after the final assessment by calculating # complete caregiver burden and BPSD assessments per consenting participant / total possible assessments.
We will separately compute missing data and attrition for all causes vs. death in the intervention vs. control groups.
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21 month outcome assessment period
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Feasibility: BCN usability
Time Frame: 3 months
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BCN usability will be assessed in the BCN intervention group at 3 months by a modified System Usability Scale (SUS), a validated 10-item scale (e.g., "Learning to use Brain CareNotes was quick for me") with a 5-point response scale (strongly disagree to strongly agree).
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3 months
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Feasibility: BCN usability
Time Frame: 6 months
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BCN usability will be assessed in the BCN intervention group at 6 months by a modified System Usability Scale (SUS), a validated 10-item scale (e.g., "Learning to use Brain CareNotes was quick for me") with a 5-point response scale (strongly disagree to strongly agree).
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6 months
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Feasibility: BCN acceptance
Time Frame: 3 months
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BCN acceptance will be assessed in the BCN intervention group at 3 months as the mean score on a Behavioral Intention scale (e.g., "If it were up to you, to what extent would you want to use the BCN app?").
The 4-item scale, adapted for health IT, uses a 7-point response scale from 0 (not at all) to 6 (a great deal).
Behavioral intention is the canonical assessment for user acceptance of technology.
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3 months
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Feasibility: BCN acceptance
Time Frame: 6 months
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BCN acceptance will be assessed in the BCN intervention group at 6 months as the mean score on a Behavioral Intention scale (e.g., "If it were up to you, to what extent would you want to use the BCN app?").
The 4-item scale, adapted for health IT, uses a 7-point response scale from 0 (not at all) to 6 (a great deal).
Behavioral intention is the canonical assessment for user acceptance of technology.
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6 months
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Feasibility: BCN use
Time Frame: 3 months
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BCN use will be collected continually from server activity (via API server queries) for log-in; survey initiation; survey completion; Notes browsed, saved, created, edited; assessment graph used; and message sent and received.
We will compute daily and weekly use rates for each use type and for "any" use at 3 months.
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3 months
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Feasibility: BCN use
Time Frame: 6 months
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BCN use will be collected continually from server activity (via API server queries) for log-in; survey initiation; survey completion; Notes browsed, saved, created, edited; assessment graph used; and message sent and received.
We will compute daily and weekly use rates for each use type and for "any" use at 6 months.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Caregiver Burden
Time Frame: baseline.
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Informal caregiver burden will be assessed by calculating the NPI-Caregiver Distress score (possible range from 0-60) from the researcher administered Neuropsychiatric Inventory (NPI) at baseline.
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baseline.
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Caregiver Burden
Time Frame: 3 months
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Informal caregiver burden will be assessed by calculating the NPI-Caregiver Distress score (possible range from 0-60) from the researcher administered Neuropsychiatric Inventory (NPI) at 3 months.
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3 months
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Caregiver Burden
Time Frame: 6 months
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Informal caregiver burden will be assessed by calculating the NPI-Caregiver Distress score (possible range from 0-60) from the researcher administered Neuropsychiatric Inventory (NPI) at 6 months.
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6 months
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Patient BPSD severity
Time Frame: baseline
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Patient behavioral and psychological symptoms of dementia (BPSD) will be assessed by calculating the NPI total score (possible range from 0-144) from the researcher- administered Neuropsychiatric Inventory (NPI) at baseline.
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baseline
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Patient BPSD severity
Time Frame: 3 months
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Patient behavioral and psychological symptoms of dementia (BPSD) will be assessed by calculating the NPI total score (possible range from 0-144) from the researcher- administered Neuropsychiatric Inventory (NPI) at 3 months.
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3 months
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Patient BPSD severity
Time Frame: 6 months
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Patient behavioral and psychological symptoms of dementia (BPSD) will be assessed by calculating the NPI total score (possible range from 0-144) from the researcher- administered Neuropsychiatric Inventory (NPI) at 6 months.
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6 months
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Acute care utilization
Time Frame: 3 months
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After patient and caregiver have been consented, all-cause hospital and emergency room admissions during the study period will be collected from electronic medical records and the Indiana Network for Patient Care (INPC), the clinical data repository of the regenstrief built regional health information exchange and computed as a rate at 3 months.
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3 months
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Acute Care Utilization
Time Frame: 6 months
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After patient and caregiver have been consented, all-cause hospital and emergency room admissions during the study period will be collected from electronic medical records and the Indiana Network for Patient Care (INPC), the clinical data repository of the regenstrief built regional health information exchange and computed as a rate at 6 months.
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6 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Malaz Boustani, MD, MPH, Indiana University
- Principal Investigator: Richard J. Holden, PhD, Indiana University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1606267154
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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