iCare-AD: A Mobile Health Application for Caregivers of Patients With Dementia.
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Alzheimer Disease, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/20/2017 |
| Start Date: | April 17, 2017 |
| End Date: | April 17, 2022 |
| Contact: | Amanda Harrawood, BS |
| Email: | aharrawo@iupui.edu |
| Phone: | 317-274-9099 |
iCare-AD: A Randomized Controlled Trial to Test the Efficacy of a Mobile Health Technology Application in Reducing the Behavioral and Psychological Symptoms of Patients With Alzheimer's Dementia and the Distress of Their Informal Caregivers
The primary purpose of this study is to test whether coupling of a mobile health technology
application (HABC 2.0) with the Aging Brain Care (ABC) Clinical Program improves (1) the
behavioral and psychological symptoms of patients suffering from Alzheimer's disease and
related dementias (ADRD) and (2) the distress of their informal caregivers.
Hypothesis #1:Patients who receive HABC 2.0 coupled with the ABC Clinical Program will have
fewer symptoms at 12 months compared to those who receive the ABC Clinical Program only; and
informal caregivers of patients who receive HABC 2.0 coupled with the ABC Clinical Program
will have lower caregiver distress at 12 months compared to caregivers of patients who
receive the ABC Clinical Program only.
The secondary purpose of this study is to test whether combining HABC 2.0 with the ABC
Clinical Program (1) reduces the number of emergency room and hospital visits for patients
and their informal caregivers; (2) reduces the depressive symptoms and caregiver burden of
informal caregivers; and (3) increases the caregiving self-efficacy of the informal
caregivers.
Hypothesis #2: Patients and caregivers who receive HABC 2.0 coupled with the ABC Clinical
Program will have fewer emergency room and hospital visits at 12 months compared to these
who receive the ABC Clinical Program only; and informal caregivers of patients who receive
HABC 2.0 coupled with the ABC Clinical Program will have fewer depressive symptoms, lower
caregiver burden and higher caregiving self-efficacy at 12 months compared to caregivers of
patients who receive the ABC Clinical Program only;.
application (HABC 2.0) with the Aging Brain Care (ABC) Clinical Program improves (1) the
behavioral and psychological symptoms of patients suffering from Alzheimer's disease and
related dementias (ADRD) and (2) the distress of their informal caregivers.
Hypothesis #1:Patients who receive HABC 2.0 coupled with the ABC Clinical Program will have
fewer symptoms at 12 months compared to those who receive the ABC Clinical Program only; and
informal caregivers of patients who receive HABC 2.0 coupled with the ABC Clinical Program
will have lower caregiver distress at 12 months compared to caregivers of patients who
receive the ABC Clinical Program only.
The secondary purpose of this study is to test whether combining HABC 2.0 with the ABC
Clinical Program (1) reduces the number of emergency room and hospital visits for patients
and their informal caregivers; (2) reduces the depressive symptoms and caregiver burden of
informal caregivers; and (3) increases the caregiving self-efficacy of the informal
caregivers.
Hypothesis #2: Patients and caregivers who receive HABC 2.0 coupled with the ABC Clinical
Program will have fewer emergency room and hospital visits at 12 months compared to these
who receive the ABC Clinical Program only; and informal caregivers of patients who receive
HABC 2.0 coupled with the ABC Clinical Program will have fewer depressive symptoms, lower
caregiver burden and higher caregiving self-efficacy at 12 months compared to caregivers of
patients who receive the ABC Clinical Program only;.
Subjects will be recruited from multiple primary care clinics affiliated with Eskenazi
Health and Indiana University Health in central Indiana. Recruitment methods will utilize
the research infrastructures of the Indiana University Practice-Based Research Network
(ResNet) and/or the Center for Aging Research (if permitted by ResNet). The recruitment will
be done face-to-face in the primary care clinics. 224 patients and their informal caregivers
(for a total of 448 human subjects) will be enrolled in the study as dyads. It is
anticipated that 80% of enrolled dyads will be identified through screening and 20% will be
referred directly to the ABC Clinical Program from physicians in primary care.
Research personnel associated with the primary care recruitment sites will review the clinic
schedules to identify adults aged 65 and older with upcoming appointments in the clinics.
Research personnel will then approach these patients to screen for memory impairment using
the Memory Impairment Screen (MIS). Patients who screen positive (MIS score <= 4) will be
referred to the ABC Clinical Program for a full diagnostic assessment to determine
eligibility. Patients referred to the ABC Clinical Program directly by their primary care
physicians will also complete the diagnostic assessment to determine eligibility.
The consent process will occur in person at the Healthy Aging Brain Center (part of the ABC
Clinical Program) after the patient has received a diagnosis of possible or probable
Alzheimer's disease and the patient and caregiver have agreed to participate in the Aging
Brain Care Clinical Program. Consent will be obtained by an individual trained in field
research and ethical conduct of human subjects research.
After informed consent has been obtained, patients and caregivers will be randomized to one
of the two study groups: the intervention group (HABC 2.0 plus ABC Clinical program) or the
comparison group (ABC Clinical Program-only). Randomization will be by dyad using a random
number generator with unequal randomization using a 3:2 ratio to achieve n=132 and n=92 in
the two arms (the larger enrollment in the intervention group), as recommended when
expecting unequal drop-out. Within two weeks of enrollment, patients and their informal
caregivers will complete a baseline assessment [including the Neuropsychiatric Inventory
(NPI), the NPI-Caregiver Stress, the Patient Health Questionnaire-9 (PHQ-9), the Zarit
Burden Interview and the Revised Scale for Caregiving Self-Efficacy] conducted by
professional interviewers blinded to the subjects' randomization status.
The intervention will continue for 12 months and primary outcomes will be assessed at
baseline, 3, 6, 9 and 12 months. Hypotheses are phrased in terms of 12 month outcomes;
however, 3, 6 and 9 month outcomes are also assessed to test early effects.
Informal caregivers will be interviewed either by telephone or in person when the patient
has an appointment in the ABC Clinical Program, to measure patients' BPSD and informal
caregivers' distress, depression, caregiver burden and caregiving self-efficacy. If at any
time during the study, a caregiver receives a score of 1, 2 or 3 on the PHQ-9 item "thoughts
that you would be better off dead or of hurting yourself in some way", the research
personnel will immediately inform a registered nurse or social worker from the ABC Clinical
Program. The registered nurse or social worker will immediately evaluate the situation and
intercede as appropriate.
Health and Indiana University Health in central Indiana. Recruitment methods will utilize
the research infrastructures of the Indiana University Practice-Based Research Network
(ResNet) and/or the Center for Aging Research (if permitted by ResNet). The recruitment will
be done face-to-face in the primary care clinics. 224 patients and their informal caregivers
(for a total of 448 human subjects) will be enrolled in the study as dyads. It is
anticipated that 80% of enrolled dyads will be identified through screening and 20% will be
referred directly to the ABC Clinical Program from physicians in primary care.
Research personnel associated with the primary care recruitment sites will review the clinic
schedules to identify adults aged 65 and older with upcoming appointments in the clinics.
Research personnel will then approach these patients to screen for memory impairment using
the Memory Impairment Screen (MIS). Patients who screen positive (MIS score <= 4) will be
referred to the ABC Clinical Program for a full diagnostic assessment to determine
eligibility. Patients referred to the ABC Clinical Program directly by their primary care
physicians will also complete the diagnostic assessment to determine eligibility.
The consent process will occur in person at the Healthy Aging Brain Center (part of the ABC
Clinical Program) after the patient has received a diagnosis of possible or probable
Alzheimer's disease and the patient and caregiver have agreed to participate in the Aging
Brain Care Clinical Program. Consent will be obtained by an individual trained in field
research and ethical conduct of human subjects research.
After informed consent has been obtained, patients and caregivers will be randomized to one
of the two study groups: the intervention group (HABC 2.0 plus ABC Clinical program) or the
comparison group (ABC Clinical Program-only). Randomization will be by dyad using a random
number generator with unequal randomization using a 3:2 ratio to achieve n=132 and n=92 in
the two arms (the larger enrollment in the intervention group), as recommended when
expecting unequal drop-out. Within two weeks of enrollment, patients and their informal
caregivers will complete a baseline assessment [including the Neuropsychiatric Inventory
(NPI), the NPI-Caregiver Stress, the Patient Health Questionnaire-9 (PHQ-9), the Zarit
Burden Interview and the Revised Scale for Caregiving Self-Efficacy] conducted by
professional interviewers blinded to the subjects' randomization status.
The intervention will continue for 12 months and primary outcomes will be assessed at
baseline, 3, 6, 9 and 12 months. Hypotheses are phrased in terms of 12 month outcomes;
however, 3, 6 and 9 month outcomes are also assessed to test early effects.
Informal caregivers will be interviewed either by telephone or in person when the patient
has an appointment in the ABC Clinical Program, to measure patients' BPSD and informal
caregivers' distress, depression, caregiver burden and caregiving self-efficacy. If at any
time during the study, a caregiver receives a score of 1, 2 or 3 on the PHQ-9 item "thoughts
that you would be better off dead or of hurting yourself in some way", the research
personnel will immediately inform a registered nurse or social worker from the ABC Clinical
Program. The registered nurse or social worker will immediately evaluate the situation and
intercede as appropriate.
Inclusion Criteria:
- Patient has received a diagnosis of possible or probable Alzheimer's disease 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 HABC 2.0;
- 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.
We found this trial at
2
sites
650 Eskenazi Avenue
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
Principal Investigator: Malaz A. Boustani, MD, MPH
Phone: 317-880-4833
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Indianapolis, Indiana 46202
Principal Investigator: Malaz A. Boustani, MD, MPH
Phone: 317-278-5323
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