Clinical trial NCT03119259: Technology Intervention to Support Caregiving for Alzheimer's Disease (I-CARE)
Official title: Technology Intervention to Support Caregiving for Alzheimer's Disease (I-CARE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia, Alzheimer Type
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2017-04-18
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility: Recruitment Rate
timeFrame: 15 month accrual period
measure: Feasibility: Data Completeness
timeFrame: 6 months after enrollment and randomization
measure: Feasibility: BCN Usability (3 Months)
timeFrame: 3 months
measure: Feasibility: BCN Usability (6 Months)
timeFrame: 6 months
measure: Feasibility: BCN Acceptance (3 Months)
timeFrame: 3 months
measure: Feasibility: BCN Acceptance (6 Months)
timeFrame: 6 months
Secondary outcomes:
measure: Caregiver Burden (Baseline)
timeFrame: baseline
measure: Caregiver Burden (3 Months)
timeFrame: 3 months
measure: Caregiver Burden (6 Months)
timeFrame: 6 months
measure: BPSD Severity (Baseline)
timeFrame: baseline
measure: BPSD Severity (3 Months)
timeFrame: 3 months
measure: BPSD Severity (6 Months)
timeFrame: 6 months
measure: Acute Care Utilization (3 Months)
timeFrame: 3 months
measure: Acute Care Utilization (6 Months)
timeFrame: 6 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Eskenazi Health
state: Indiana
city: Indianapolis
country: United States
facility: IU Health
state: Indiana
Study officials:
affiliation: Indiana University
name: Richard J. Holden, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University
name: Malaz Boustani, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Braly T, Muriathiri D, Brown JC, Taylor BM, Boustani MA, Holden RJ. Technology intervention to support caregiving for Alzheimer's disease (I-CARE): study protocol for a randomized controlled pilot trial. Pilot Feasibility Stud. 2021 Jan 11;7(1):23. doi: 10.1186/s40814-020-00755-2.