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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;.
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.
Dementia, Alzheimer Type
ABC Clinical Program, HABC 2.0
Not yet recruiting
Published on BioPortfolio: 2017-04-19T06:23:21-0400
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