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

NCT03119259 | Completed Results

• 2 other identifiers: 1606267154R21AG062966
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 2

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.

Conditions

Dementia, Alzheimer Type

Outcome Measures

Primary Outcomes (6)

• Feasibility: Recruitment Rate

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

  15 month accrual period

• Feasibility: Data Completeness

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

  6 months after enrollment and randomization

• Feasibility: BCN Usability (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).

  3 months

• Feasibility: BCN Usability (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.

  6 months

• Feasibility: BCN Acceptance (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.

  3 months

• Feasibility: BCN Acceptance (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).

  6 months

Secondary Outcomes (8)

• Caregiver Burden (Baseline)

  baseline

• Caregiver Burden (3 Months)

  3 months

• Caregiver Burden (6 Months)

  6 months

• BPSD Severity (Baseline)

  baseline

• BPSD Severity (3 Months)

  3 months

Study Arms (2)

ABC Clinical Program Only and Usual Care

ACTIVE COMPARATOR

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.

Behavioral: ABC Clinical Program

BCN Mobile App Plus ABC and BCN Mobile app only

EXPERIMENTAL

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.

Behavioral: ABC Clinical Program; Behavioral: BCN

Interventions

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.

Also known as: IUHP Usual Care

ABC Clinical Program Only and Usual Care; BCN Mobile App Plus ABC and BCN Mobile app only

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: 1. 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"; 2. 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; 3. 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.

BCN Mobile App Plus ABC and BCN Mobile app only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Indiana University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (2)

Eskenazi Health

Indianapolis, Indiana, 46202, United States

Location

IU Health

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

• 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.

  PMID: 33431027 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

BCN usage (a primary feasibility outcome) continues to be analyzed and data are not reported. Data are reported from consented informal caregivers only. Caregivers provided data on themselves and the patient. Data on secondary outcomes of Caregiver Burden and Patient Symptom Severity were imputed for all randomized participants. Acute care utilization data combine emergency room (ER) and hospital based admissions.

Results Point of Contact

• Title: Dr. Richard Holden
• Organization: Indiana University

rjholden@iu.edu

812-586-1965

Study Officials

• Richard J. Holden, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

• Malaz Boustani, MD, MPH

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Health & Wellness Design

Study Record Dates

• First Submitted: April 12, 2017
• First Posted: April 18, 2017
• Study Start: November 25, 2019
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 10 years from the completion of the study
• Access Criteria: To obtain IDP, requesters must provide a CV or biosketch detailing their institutional affiliation(s), the scientific purpose for the data sharing request, and plans for the safe and secure management of deidentified study data.

Locations

US (2)