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I-CARE 2: Mobile Telehealth to Reduce Alzheimer'S-related Symptoms in Hispanic Individuals

Primary Purpose

Caregiver Burden, Alzheimer Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brain CareNotes
Dementia Guide Expert
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Caregiver Burden focused on measuring Alzheimer's disease and related dementias, Hispanic caregivers, Caregiver Burden, Behavioral and psychological symptoms of dementia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mount Sinai Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Brain CareNotes

Attention Control App

Arm Description

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.

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."

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
Caregiver Acute Care Utilization
Caregiver visits to emergency rooms, hospitals, or inpatient diagnoses. Obtained from caregiver self-reports or medical records.
Patient Acute Care Utilization
Patient visits to emergency rooms, hospitals, or inpatient diagnoses. Obtained from caregiver self-reports or medical records.

Full Information

First Posted
October 19, 2023
Last Updated
October 19, 2023
Sponsor
Indiana University
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT06099197
Brief Title
I-CARE 2: Mobile Telehealth to Reduce Alzheimer'S-related Symptoms in Hispanic Individuals
Official Title
I-CARE 2 RCT: Mobile Telehealth to Reduce Alzheimer'S-related Symptoms for Hispanic Caregivers and Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 26, 2023 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 Hispanic caregivers of patients with dementia and on the behavioral and psychological symptoms of dementia (BPSD) displayed by care recipients. Over 10 months, the trial will enroll 40 Hispanic 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 10 months, the trial will enroll 40 Hispanic 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, three, 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, three, 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. The final objective is to determine the shortcomings of Brain CareNotes in supporting the specific needs of Hispanic caregivers. Upon their completion of the study, participants in the intervention arm will complete semi-structured qualitative interviews.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregiver Burden, Alzheimer Disease
Keywords
Alzheimer's disease and related dementias, Hispanic caregivers, Caregiver Burden, Behavioral and psychological symptoms of dementia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized to receive the Brain CareNotes app or an attention control app.
Masking
InvestigatorOutcomes Assessor
Masking Description
The primary investigator and outcome assessor will be masked to the app assignment (Brain CareNotes vs Attention Control App).
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brain CareNotes
Arm Type
Experimental
Arm Description
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.
Arm Title
Attention Control App
Arm Type
Active Comparator
Arm Description
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."
Intervention Type
Behavioral
Intervention Name(s)
Brain CareNotes
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dementia Guide Expert
Intervention Description
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."
Primary Outcome Measure Information:
Title
Caregiver Burden
Description
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.
Time Frame
12 months
Title
Patient BPSD
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Caregiver Depressive Symptoms
Description
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.
Time Frame
12 months
Title
Caregiver Acute Care Utilization
Description
Caregiver visits to emergency rooms, hospitals, or inpatient diagnoses. Obtained from caregiver self-reports or medical records.
Time Frame
12 months
Title
Patient Acute Care Utilization
Description
Patient visits to emergency rooms, hospitals, or inpatient diagnoses. Obtained from caregiver self-reports or medical records.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Caregiver Self-efficacy
Description
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.
Time Frame
12 months
Title
Caregiver Social Support
Description
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.
Time Frame
12 months
Title
System Usability Scale
Description
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.
Time Frame
12 months
Title
Behavioral Intention Questionnaire
Description
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.
Time Frame
12 months
Title
App Use
Description
Usage logs of app use over time.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Caregiver Inclusion Criteria: Self-identified primary unpaid Hispanic caregiver of a person diagnosed with ADRD (at any stage) who are: Receiving primary care and Community-dwelling; English literate; Age ≥ 18 years 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miriam J Rodriguez, PhD
Phone
(812) 856-1661
Email
mijrodri@iu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jordan R Hill, PhD
Phone
(812) 856-5032
Email
jrh6@iu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard J Holden, PhD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Malaz Boustani, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Ruiz
Email
Maria.Ruiz@msmc.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

I-CARE 2: Mobile Telehealth to Reduce Alzheimer'S-related Symptoms in Hispanic Individuals

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