Track topics on Twitter Track topics that are important to you
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
To evaluate the superiority of brexpiprazole 1 mg or 2 mg over placebo after a 10-week treatment regimen for agitation associated with dementia of the Alzheimer's type in patients who requ...
This study compares the efficacy of 2 doses of brexpiprazole with placebo in subjects with agitation associated with dementia of the Alzheimer's type.
The purpose of this study is to assess the efficacy and safety of AZD3293 compared with placebo administered for 104 weeks in the treatment of early Alzheimer´s disease. The study will te...
Assessment of the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6 DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in participants with dementia of the Alzheime...
The purpose of this study is to learn if aripiprazole is safe and effective in the treatment of psychosis associated with dementia of the Alzheimer's type.
Alzheimer disease is the most common type of dementia. Two classes of cognition-enhancing drugs are approved to treat the symptoms, and both have provided modest benefit in clinical trials. Psychotrop...
Alzheimer's dementia (AD) is the commonest type of dementia presenting with initial episodic memory decline followed by involvement of other cognitive domains. Posterior cortical atrophy (PCA) is one ...
The diagnosis of either Alzheimer's disease (AD) or vascular dementia (VaD) is still largely based on clinical guidelines and exclusion of other diseases that may lead to dementia.
Here, we have extensively investigated the relationship between thermoregulation and neurodegeneration-induced dementia of the Alzheimer's type using intracerebroventricular injections of streptozotoc...
The correct classification of non-Alzheimer's dementia is crucial to study disease mechanisms, predict disease progression and test disease-specific treatments. Brain atrophy assessment with morphomet...
A progressive form of dementia characterized by the global loss of language abilities and initial preservation of other cognitive functions. Fluent and nonfluent subtypes have been described. Eventually a pattern of global cognitive dysfunction, similar to ALZHEIMER DISEASE, emerges. Pathologically, there are no Alzheimer or PICK DISEASE like changes, however, spongiform changes of cortical layers II and III are present in the TEMPORAL LOBE and FRONTAL LOBE. (From Brain 1998 Jan;121(Pt 1):115-26)
The most common clinical form of FRONTOTEMPORAL LOBAR DEGENERATION, this dementia presents with personality and behavioral changes often associated with disinhibition, apathy, and lack of insight.
Heterogeneous group of neurodegenerative disorders characterized by frontal and temporal lobe atrophy associated with neuronal loss, gliosis, and dementia. Patients exhibit progressive changes in social, behavioral, and/or language function. Multiple subtypes or forms are recognized based on presence or absence of TAU PROTEIN inclusions. FTLD includes three clinical syndromes: FRONTOTEMPORAL DEMENTIA, semantic dementia, and PRIMARY PROGRESSIVE NONFLUENT APHASIA.
A carbamate-derived reversible CHOLINESTERASE INHIBITOR that is selective for the CENTRAL NERVOUS SYSTEM and is used for the treatment of DEMENTIA in ALZHEIMER DISEASE and PARKINSON DISEASE.
A form of presenile DEMENTIA characterized by cortical dementia, NEUROFIBRILLARY TANGLES without SENILE PLAQUES, Fahr's type CALCINOSIS, and ATROPHY in frontotemporal or TEMPORAL LOBE.
Neurology - Central Nervous System (CNS)
Alzheimer's Disease Anesthesia Anxiety Disorders Autism Bipolar Disorders Dementia Epilepsy Multiple Sclerosis (MS) Neurology Pain Parkinson's Disease Sleep Disorders Neurology is the branch of me...
Stress is caused by your perception of situations around you and then the reaction of your body to them. The automatic stress response to unexpected events is known as 'fight or flight'. Discovered by Walter Cannon in 1932, it is the release of h...