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

• ClinicalTrials.gov Identifier: NCT05733520
• Recruitment Status: Recruiting
• First Posted: February 17, 2023
• Last Update Posted: September 29, 2023
• Sponsor: Indiana University
• Collaborators: National Institute on Aging (NIA); Regenstrief Institute, Inc.
• Information provided by (Responsible Party): Richard Holden, Indiana University

Tracking Information

• First Submitted Date: February 8, 2023
• First Posted Date: February 17, 2023
• Last Update Posted Date: September 29, 2023
• Actual Study Start Date: May 30, 2023
• Estimated Primary Completion Date: July 30, 2027 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 15, 2023)

• Caregiver Burden [ Time Frame: 12 months ]
  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.
• Patient BPSD [ Time Frame: 12 months ]
  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.

Original Primary Outcome Measures (submitted: February 8, 2023)

• Caregiver Burden [ Time Frame: 12 months ]
  The burden experienced by caregivers caused by their caregiving responsibilities measured by the Neuropsychiatric Inventory (NPI) caregiver distress sub-score.
• Patient BPSD [ Time Frame: 12 months ]
  Behavioral (e.g. agitation, aggression, wandering) and psychological (e.g. delusions, hallucinations) symptoms of dementia as measured by the Neuropsychiatric Inventory (NPI).

Current Secondary Outcome Measures (submitted: September 28, 2023)

• Caregiver Depressive Symptoms [ Time Frame: 12 months ]
  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.
• Caregiver Acute Care Utilization [ Time Frame: 12 months ]
  Caregiver visits to emergency rooms, hospitals, or inpatient diagnoses. Obtained from caregiver self-reports or medical records.
• Patient Acute Care Utilization [ Time Frame: 12 months ]
  Patient visits to emergency rooms, hospitals, or inpatient diagnoses. Obtained from caregiver self-reports or medical records.

Original Secondary Outcome Measures (submitted: February 8, 2023)

• Caregiver Depressive Symptoms [ Time Frame: 12 months ]
  Caregiver depression as measured by the Patient Health Questionnaire (PHQ)-9
• Caregiver Acute Care Utilization [ Time Frame: 12 months ]
  Caregiver visits to emergency rooms, hospitals, or inpatient diagnoses. Obtained from caregiver self-reports or medical records.
• Patient Acute Care Utilization [ Time Frame: 12 months ]
  Patient visits to emergency rooms, hospitals, or inpatient diagnoses. Obtained from caregiver self-reports or medical records.

Current Other Pre-specified Outcome Measures (submitted: March 15, 2023)

• Caregiver Self-efficacy [ Time Frame: 12 months ]
  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.
• Caregiver Social Support [ Time Frame: 12 months ]
  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.
• System Usability Scale [ Time Frame: 12 months ]
  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.
• Behavioral Intention Questionnaire [ Time Frame: 12 months ]
  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.
• App Use [ Time Frame: 12 months ]
  Usage logs of app use over time.

Original Other Pre-specified Outcome Measures (submitted: February 8, 2023)

• Caregiver Self-efficacy [ Time Frame: 12 months ]
  Caregiver perceived self-efficacy as measured using the Revised Scale for Caregiving Self-Efficacy
• Caregiver Social Support [ Time Frame: 12 months ]
  Caregiver perceived social support measured using the Multidimensional Scale of Perceived Social Support (MSPSS)
• System Usability Scale [ Time Frame: 12 months ]
  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
• Behavioral Intention Questionnaire [ Time Frame: 12 months ]
  4-item questionnaire assessing a user's intention to use a technology in the near future.
• App Use [ Time Frame: 12 months ]
  Usage logs of app use over time.

Descriptive Information

• Brief Title: I-CARE 2: Mobile Telehealth to Reduce Alzheimer'S-related Symptoms
• Official Title: I-CARE 2 RCT: Mobile Telehealth to Reduce Alzheimer'S-related Symptoms for Caregivers and Patients
• Brief Summary: 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.

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
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Participants will be randomized to receive the Brain CareNotes app or an attention control app.

Masking: Double (Investigator, Outcomes Assessor)
Masking Description:

The primary investigator and outcome assessor will be masked to the App assignment (Brain CareNotes vs Attention Control App)

Primary Purpose: Supportive Care

Condition

• Caregiver Burden
• Alzheimer Disease

Intervention

• 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.
• 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."

Study Arms

• Experimental: Brain CareNotes App
  Intervention: Behavioral: Brain CareNotes
• Active Comparator: Attention Control App
  Intervention: Behavioral: Dementia Guide Expert

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: February 8, 2023): 160
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 30, 2027
• Estimated Primary Completion Date: July 30, 2027 (Final data collection date for primary outcome measure)

Eligibility Criteria

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Miriam J Rodriguez, PhD; (812) 856-1661; mijrodri@iu.edu

Contact: Jordan R Hill, PhD; 812-856-5032; jrh6@iu.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05733520
• Other Study ID Numbers: 15749; R01AG078234 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Richard Holden, Indiana University
• Original Responsible Party: Same as current
• Current Study Sponsor: Indiana University
• Original Study Sponsor: Same as current

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

• PRS Account: Indiana University
• Verification Date: September 2023