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

Not Applicable

Completed

• Conditions: Dementia, Alzheimer Type
• Interventions: Behavioral: ABC Clinical Program; Behavioral: BCN

• Registration Number: NCT03119259
• Lead Sponsor: Indiana University

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-04-12
• Study First Submitted QC: 2017-04-13
• Study First Posted: 2017-04-18
• Study Start: 2019-11-25
• Primary Completion: 2021-07-31
• Study Completion: 2021-07-31
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-01
• Last Update Posted: 2021-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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).

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABC Clinical Program Only and Usual Care	ABC Clinical Program	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.
BCN Mobile App Plus ABC and BCN Mobile app only	ABC Clinical Program	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.
BCN Mobile App Plus ABC and BCN Mobile app only	BCN	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.

Primary Outcome Measures

Name	Time	Method
Feasibility: Recruitment Rate	15 month accrual period	Recruitment rate is the average monthly rate of recruitment into the study, calculated as participants recruited over the accrual period.
Feasibility: Data Completeness	6 months after enrollment and randomization	Data completeness is the number of enrolled and randomized individuals who provided data at 3 and 6 months.
Feasibility: BCN Usability (3 Months)	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).
Feasibility: BCN Usability (6 Months)	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.
Feasibility: BCN Acceptance (3 Months)	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.
Feasibility: BCN Acceptance (6 Months)	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 Outcome Measures

Name	Time	Method
Caregiver Burden (Baseline)	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)
Caregiver Burden (3 Months)	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)
Caregiver Burden (6 Months)	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)
BPSD Severity (Baseline)	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).
BPSD Severity (3 Months)	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).
BPSD Severity (6 Months)	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).
Acute Care Utilization (3 Months)	3 months	Number of all-cause hospital and emergency room admissions among patients and caregivers in the first 3 months (3 months post-intervention).
Acute Care Utilization (6 Months)	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).

Trial Locations

Locations (2)

Eskenazi Health; 🇺🇸 Indianapolis, Indiana, United States

IU Health; 🇺🇸 Indianapolis, Indiana, United States