Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03119259
Recruitment Status : Recruiting
First Posted : April 18, 2017
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Richard Holden, Indiana University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Dementia, Alzheimer Type Behavioral: ABC Clinical Program Behavioral: BCN Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Technology Intervention to Support Caregiving for Alzheimer's Disease (I-CARE)
Actual Study Start Date : November 25, 2019
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ABC Clinical Program Only and Usual Care
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

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.

Other Name: IUHP Usual Care

Experimental: BCN Mobile App Plus ABC and BCN Mobile app only
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

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.

Other Name: IUHP Usual Care

Behavioral: BCN

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.




Primary Outcome Measures :
  1. Feasibility: Recruitment rate [ Time Frame: 15 month accrual period ]
    Recruitment rate will be collected continually and computed at the end of the accrual period by calculating # approached, # agreeing, # consenting, and # consenting / # approached. We will also calculate the monthly rate.

  2. Feasibility: Data completeness [ Time Frame: 21 month outcome assessment period ]
    Data completion will be collected continually and computed after the final assessment by calculating # complete caregiver burden and BPSD assessments per consenting participant / total possible assessments. We will separately compute missing data and attrition for all causes vs. death in the intervention vs. control groups.

  3. Feasibility: BCN usability [ Time Frame: 3 months ]
    BCN usability will be assessed in the BCN intervention group at 3 months by a modified System Usability Scale (SUS), a validated 10-item scale (e.g., "Learning to use Brain CareNotes was quick for me") with a 5-point response scale (strongly disagree to strongly agree).

  4. Feasibility: BCN usability [ Time Frame: 6 months ]
    BCN usability will be assessed in the BCN intervention group at 6 months by a modified System Usability Scale (SUS), a validated 10-item scale (e.g., "Learning to use Brain CareNotes was quick for me") with a 5-point response scale (strongly disagree to strongly agree).

  5. Feasibility: BCN acceptance [ Time Frame: 3 months ]
    BCN acceptance will be assessed in the BCN intervention group at 3 months as the mean score on a Behavioral Intention scale (e.g., "If it were up to you, to what extent would you want to use the BCN app?"). The 4-item scale, adapted for health IT, uses a 7-point response scale from 0 (not at all) to 6 (a great deal). Behavioral intention is the canonical assessment for user acceptance of technology.

  6. Feasibility: BCN acceptance [ Time Frame: 6 months ]
    BCN acceptance will be assessed in the BCN intervention group at 6 months as the mean score on a Behavioral Intention scale (e.g., "If it were up to you, to what extent would you want to use the BCN app?"). The 4-item scale, adapted for health IT, uses a 7-point response scale from 0 (not at all) to 6 (a great deal). Behavioral intention is the canonical assessment for user acceptance of technology.

  7. Feasibility: BCN use [ Time Frame: 3 months ]
    BCN use will be collected continually from server activity (via API server queries) for log-in; survey initiation; survey completion; Notes browsed, saved, created, edited; assessment graph used; and message sent and received. We will compute daily and weekly use rates for each use type and for "any" use at 3 months.

  8. Feasibility: BCN use [ Time Frame: 6 months ]
    BCN use will be collected continually from server activity (via API server queries) for log-in; survey initiation; survey completion; Notes browsed, saved, created, edited; assessment graph used; and message sent and received. We will compute daily and weekly use rates for each use type and for "any" use at 6 months.


Secondary Outcome Measures :
  1. Caregiver Burden [ Time Frame: baseline. ]
    Informal caregiver burden will be assessed by calculating the NPI-Caregiver Distress score (possible range from 0-60) from the researcher administered Neuropsychiatric Inventory (NPI) at baseline.

  2. Caregiver Burden [ Time Frame: 3 months ]
    Informal caregiver burden will be assessed by calculating the NPI-Caregiver Distress score (possible range from 0-60) from the researcher administered Neuropsychiatric Inventory (NPI) at 3 months.

  3. Caregiver Burden [ Time Frame: 6 months ]
    Informal caregiver burden will be assessed by calculating the NPI-Caregiver Distress score (possible range from 0-60) from the researcher administered Neuropsychiatric Inventory (NPI) at 6 months.

  4. Patient BPSD severity [ Time Frame: baseline ]
    Patient behavioral and psychological symptoms of dementia (BPSD) will be assessed by calculating the NPI total score (possible range from 0-144) from the researcher- administered Neuropsychiatric Inventory (NPI) at baseline.

  5. Patient BPSD severity [ Time Frame: 3 months ]
    Patient behavioral and psychological symptoms of dementia (BPSD) will be assessed by calculating the NPI total score (possible range from 0-144) from the researcher- administered Neuropsychiatric Inventory (NPI) at 3 months.

  6. Patient BPSD severity [ Time Frame: 6 months ]
    Patient behavioral and psychological symptoms of dementia (BPSD) will be assessed by calculating the NPI total score (possible range from 0-144) from the researcher- administered Neuropsychiatric Inventory (NPI) at 6 months.

  7. Acute care utilization [ Time Frame: 3 months ]
    After patient and caregiver have been consented, all-cause hospital and emergency room admissions during the study period will be collected from electronic medical records and the Indiana Network for Patient Care (INPC), the clinical data repository of the regenstrief built regional health information exchange and computed as a rate at 3 months.

  8. Acute Care Utilization [ Time Frame: 6 months ]
    After patient and caregiver have been consented, all-cause hospital and emergency room admissions during the study period will be collected from electronic medical records and the Indiana Network for Patient Care (INPC), the clinical data repository of the regenstrief built regional health information exchange and computed as a rate at 6 months.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119259


Contacts
Layout table for location contacts
Contact: Dana Musapatika, MS 317-260-1860 dalmcdon@iu.edu
Contact: Doris Muriathiri, MPH, CCRP 317-260-1860 dmuriath@iupui.edu

Locations
Layout table for location information
United States, Indiana
Eskenazi Health Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Catherine A. Alder, JD, MSW    317-880-4833    catherine.alder@eskenazihealth.edu   
Principal Investigator: Malaz A. Boustani, MD, MPH         
Sub-Investigator: Daniel R. Bateman, MD         
IU Health Not yet recruiting
Indianapolis, Indiana, United States, 46202
Contact: Richard J. Holden, PhD    317-278-5323    rjholden@iupui.edu   
Principal Investigator: Malaz A. Boustani, MD, MPH         
Sub-Investigator: Daniel R. Bateman, MD         
Sub-Investigator: Daniel O. Clark, PhD         
Sub-Investigator: Nicole R. Fowler, PhD         
Sub-Investigator: Patrick O. Monahan, PhD         
Sponsors and Collaborators
Indiana University
Investigators
Layout table for investigator information
Principal Investigator: Richard J. Holden, PhD Indiana University
Principal Investigator: Malaz Boustani, MD, MPH Indiana University
Layout table for additonal information
Responsible Party: Richard Holden, Associate Professor of Medicine, Division of General Internal and Geriatrics, Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT03119259    
Other Study ID Numbers: 1606267154
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data, or results, will be shared through traditional mechanisms such as peer-reviewed journals and presentations at national meetings. The Enhanced Medical Record - Aging Brain Care (eMR-ABC), the dedicated electronic medical record for the Aging Brain Care (ABC) Clinical Program, was developed with the intent of sharing de-identified data with the scientific community. The Indiana Network for Patient Care (INPC) is a state-wide health information exchange. INPC data is collected for patient care purposes and is not "owned" by Indiana University or the Regenstrief Institute, Inc. - each participating health care system or program retains ownership of their data. At present, Indiana University/Regenstrief Institute scientists do not have the direct authority to share even de-identified patient data. Therefore, any request to use these data for research purposes must be adjudicated on a case-by-case basis.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders