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

• ClinicalTrials.gov Identifier: NCT03119259
• Recruitment Status: Completed
• First Posted: April 18, 2017
• Last Update Posted: September 5, 2021
• Sponsor: Indiana University
• Information provided by (Responsible Party): Richard Holden, Indiana University

Tracking Information

• First Submitted Date: April 12, 2017
• First Posted Date: April 18, 2017
• Last Update Posted Date: September 5, 2021
• Actual Study Start Date: November 25, 2019
• Actual Primary Completion Date: July 31, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 16, 2020)

• 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.
• 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.
• 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).
• 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).
• 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.
• 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.
• 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.
• 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.

Original Primary Outcome Measures (submitted: April 13, 2017)

Behavioral and Psychological Symptoms of Dementia (BPSD) and Caregiver Distress [ Time Frame: 12 months ]

We will use the total score of the Neuropsychiatric Inventory (NPI) to measure BPSD and the NPI-Caregiver Distress Subscore to measure informal caregiver distress. The NPI obtains information on the presence of psychopathology in 10 behavioral areas including delusions, apathy, hallucinations, disinhibition, agitation, depression, aberrant motor behavior, anxiety, night-time behavior, and euphoria. Possible scores range from 0-144. The inventory is interviewer-administered to an informal caregiver. If the caregiver reports the presence of psychopathology, there are follow-up questions to assess frequency, severity, and the level of caregiver distress due to the behavior. Thus, the instrument is specifically designed to measure informal caregiver burden by calculating the NPI-Caregiver Distress score (possible range from 0-60). Total administration time is about 20 minutes. The test has excellent reliability and validity.

Current Secondary Outcome Measures (submitted: January 16, 2020)

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Original Secondary Outcome Measures (submitted: April 13, 2017)

• Health Care Utilization [ Time Frame: 3, 6, 9 and 12 months ]
  We will obtain consent at enrollment from all subjects and their informal caregivers for permission to review their electronic medical records. We will then use the INPC to identify any episode of ambulatory or acute care that occurred within the 12 months following their enrollment date. We will structure continuous variables that describe the number of ambulatory and/or acute care episodes. Furthermore, we will structure additional variables that describe a potentially preventable hospital admission (preventable hospitalization). Preventable hospitalization will include any hospitalization for an International Classification of Diseases (ICD)-10 based disease that is considered an ambulatory care sensitive condition where the condition itself or its course can be mitigated through optimal outpatient management.
• Caregiver Depression [ Time Frame: 3, 6, 9 and 12 months ]
  We ill use the total score of the Patient Health Questionnaire - 9 (PHQ-9) to measure caregiver depression. The PHQ-9 is a nine-item depression scale with a total score from 0 to 27, has good internal consistency and test-retest reliability as well as convergent, construct, criterion, procedural and factorial validity for the diagnosis of major depression.
• Caregiver Burden [ Time Frame: 3, 6, 9 and 12 months ]
  We will use the Zarit Burden Interview to measure caregiver burden. This brief 12 item instrument assesses role strain and personal strain among caregivers. It is a widely used instrument with excellent psychometric properties. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always).
• Caregiver Self-Efficacy [ Time Frame: 3, 6, 9 and 12 months ]
  Self-efficacy is a construct from Social Learning Theory and refers to a subjective belief that a person has about his or her ability to successfully carry out certain kinds of behavior. We will measure this construct using the Revised Scale for Caregiving Self-Efficacy. This measure contains 15 items within 3 subscales (self-efficacy for obtaining respite, responding to disruptive patient behaviors, and controlling upsetting thoughts about caregiving). Items are rated on a 0-100 scale for current beliefs.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Technology Intervention to Support Caregiving for Alzheimer's Disease (I-CARE)
• Official Title: Technology Intervention to Support Caregiving for Alzheimer's Disease (I-CARE)
• 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.

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Health Services Research
• Condition: Dementia, Alzheimer Type

Intervention

• 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.

Study Arms

• 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.
  Intervention: Behavioral: ABC Clinical Program
• 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.
  Interventions:

  • Behavioral: ABC Clinical Program
  • Behavioral: BCN

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 1, 2021): 61
• Original Estimated Enrollment (submitted: April 13, 2017): 448
• Actual Study Completion Date: July 31, 2021
• Actual Primary Completion Date: July 31, 2021 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03119259
• Other Study ID Numbers: 1606267154
• Has Data Monitoring Committee: No

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: 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.

• Current Responsible Party: Richard Holden, Indiana University
• Original Responsible Party: Richard Holden, Indiana University, Assistant Professor, School of Informatics and Computing
• Current Study Sponsor: Indiana University
• Original Study Sponsor: Richard Holden
• Collaborators: Not Provided

Investigators

• Principal Investigator: Richard J. Holden, PhD; Indiana University
• Principal Investigator: Malaz Boustani, MD, MPH; Indiana University

• PRS Account: Indiana University
• Verification Date: September 2021