I-CARE 2: Mobile Telehealth to Reduce Alzheimer'S-related Symptoms (I-CARE 2)

I-CARE 2 RCT: Mobile Telehealth to Reduce Alzheimer'S-related Symptoms for Caregivers and Patients

This study is a randomized, controlled trial (RCT) to evaluate the effect of Brain CareNotes (a mobile health application) on the burden experienced by unpaid caregivers of patients with dementia and on the behavioral and psychological symptoms of dementia (BPSD) displayed by care recipients. Over 39 months, the trial will enroll 160 caregivers of community-dwelling patients diagnosed with Alzheimer's disease or a related dementia (ADRD). Caregivers will be randomized to use the Brain CareNotes app or an attention control education-only app for 12 months, with usage reminders.

Study Overview

• Status: Recruiting
• Conditions: Alzheimer Disease; Caregiver Burden
• Intervention / Treatment: Behavioral: Dementia Guide Expert; Behavioral: Brain CareNotes

Detailed Description

This study is a hybrid efficacy-effectiveness RCT to evaluate the effect of Brain CareNotes on unpaid caregiver burden and patient BPSD. Over 39 months, the trial will enroll 160 caregivers. Participants will be randomized to use the Brain CareNotes app or an attention control education-only app (Dementia Guide Expert) for 12 months.

The primary objective is to test the effect of Brain CareNotes on a) caregiver burden and b) patient BPSD at 12 months. The investigators hypothesize that caregiver burden and patient BPSD will be lower among those participants randomized to the Brain CareNotes intervention compared to those randomized to the education-only attention control app at 12 months. The primary, powered outcomes are calculated using the caregiver-reported Neuropsychiatric Inventory (NPI); the total NPI score measures patient BSPD and the caregiver distress sub-score measures caregiver burden. The investigators will obtain NPI responses from caregivers at baseline, six, and 12 months.

The secondary objective is to test the effect of Brain CareNotes on a) caregiver depressive symptoms and b) patient and caregiver acute care utilization at 12 months. The investigators hypothesize that participants randomized to the Brain CareNotes intervention will have lower caregiver depressive symptoms and decreased acute care utilization compared to those randomized to the control app. For caregiver depressive symptoms, investigators will use the researcher-administered Patient Health Questionnaire-9 (PHQ-9) at baseline, six, and 12 months. Acute care utilization data will be obtained from self-reports or Indiana's statewide Health Information Exchange (HIE), known as the Indiana Network for Patient Care (INPC), to identify both caregivers' and patients' hospital and ER visits that occurred within 12 months of enrollment.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Miriam J Rodriguez, PhD; Phone Number: (812) 856-1661; Email: mijrodri@iu.edu
• Study Contact Backup: Name: Jordan R Hill, PhD; Phone Number: 812-856-5032; Email: jrh6@iu.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • IU Health
      • Contact: Malaz Boustani, MD
    • Indianapolis, Indiana, United States, 46203
      • Recruiting
      • Community Health Network
      • Contact: Molly Campbell, DNP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Caregiver Inclusion Criteria:

• Self-identified primary unpaid caregiver of a person diagnosed with ADRD (at any stage) who are:
• Receiving primary care and
• Community-dwelling;
• English literate;
• Age ≥ 18 years

Caregiver Exclusion Criteria:

• Care recipient is a permanent resident of an extended care facility (nursing home);
• Involvement in another clinical trial that would prevent or interfere with study objectives;
• Sensory or other impairment prohibiting the use of a mobile touchscreen device or other study activity (after correction)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brain CareNotes App	Behavioral: Brain CareNotes; The Brain CareNotes mobile telehealth app is used by unpaid caregivers for BPSD management. It includes remote communication with an external human support person-a care coach-as well as features for users to independently perform health-related activities.
Active Comparator: Attention Control App	Behavioral: Dementia Guide Expert; Dementia Guide Expert provides education only and no interactive BPSD management support, coaching, assessment, or external response. It contains "evidence-based expert information on what dementia is, types, contributing factors, risks, symptoms, stages, diagnosis, tests, treatment, management, communication techniques, and links to resources and support services."

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiver Burden	The burden experienced by caregivers caused by their caregiving responsibilities measured by the Neuropsychiatric Inventory (NPI) caregiver distress sub-score. The distress score is calculated by adding the distress score for each of the 12 items of the NPI. A score of 0 would indicate that the BPSD cause no distress while a score of 60 would indicate that each symptom causes severe distress for the caregiver.	12 months
Patient BPSD	Behavioral (e.g. agitation, aggression, wandering) and psychological (e.g. delusions, hallucinations) symptoms of dementia as measured by the Neuropsychiatric Inventory (NPI). The NPI is a 12-item questionnaire. The total score is calculated by adding the product of the frequency and severity of those 12 items. A score of 0 would indicate that no symptoms are present while a score of 144 would indicate that all symptoms are present at the highest level of frequency and severity.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiver Acute Care Utilization	Caregiver visits to emergency rooms, hospitals, or inpatient diagnoses. Obtained from caregiver self-reports or medical records.	12 months
Patient Acute Care Utilization	Patient visits to emergency rooms, hospitals, or inpatient diagnoses. Obtained from caregiver self-reports or medical records.	12 months
Caregiver Depressive Symptoms	Caregiver depression as measured by the Patient Health Questionnaire (PHQ)-9. The PHQ-9 is a 9-item questionnaire using a 0-3 rating scale. Scores range from 0-27. A total score of 0 represents no depression, while score of 5, 10, 15, and 20 serve as cut points for mild, moderate, moderately severe, and severe depression, respectively.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
App Use	Usage logs of app use over time.	12 months
Caregiver Self-efficacy	Caregiver perceived self-efficacy as measured using the Revised Scale for Caregiving Self-Efficacy. It consists of 3 sections each with five items. Participants rank self-efficacy on a scale of 0-100 for each item, with a higher score representing greater confidence. Thus, a high total score represents greater self-efficacy.	12 months
Caregiver Social Support	Caregiver perceived social support measured using the Multidimensional Scale of Perceived Social Support (MSPSS). The MSPSS is a 12-item questionnaire using a 7-point Likert scale where 1=very strongly disagree and 7=very strongly agree. Scores range from 12-84. A low score represents minimal social support while a high score represents a great level of perceived social support.	12 months
System Usability Scale	10-item standardized survey of user-reported technology usability, based on revised System Usability Scale, with scale score computed ranging from 0-100, with 100 indicating highest possible perceived usability.	12 months
Behavioral Intention Questionnaire	A 4-item questionnaire assessing a user's intention to use a technology in the near future. Scores range from 0-24 with a high score representing greater intention to use the technology.	12 months

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: National Institute on Aging (NIA); Regenstrief Institute, Inc.
• Investigators: Principal Investigator: Richard J Holden, PhD, Indiana University; Principal Investigator: Malaz Boustani, MD, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2023
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2027

Study Registration Dates

• First Submitted: February 8, 2023
• First Submitted That Met QC Criteria: February 8, 2023
• First Posted (Actual): February 17, 2023

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Caregiver Burden; Caregiver; Behavioral and psychological symptoms of dementia; Alzheimer's disease and related dementias
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Stress, Psychological; Dementia; Tauopathies; Alzheimer Disease; Caregiver Burden
• Other Study ID Numbers: 15749; R01AG078234 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No