Alzheimer Disease Clinical Trial
Official title:
A Comprehensive Care Coordination and Management Platform for Alzheimer's Disease and Related Dementia (Care4AD)
Dementia, a chronic disease of aging, is characterized by progressive cognitive decline that interferes with independent functioning. The medical, psychological, social and functional sequelae of dementia cause great stress to patients, their caregivers, and their family. The investigator proposes to examine effectivness of a home-based care coordination and management device, called Care4AD to help caregivers effectively coordinate, manage, and improve dementia care.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 1, 2024 |
Est. primary completion date | May 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria include: - Older patients (> 65 years old) with mild or moderate Alzheimer's Disease - Must be ambulatory - Must be in a residential home with a caregiver/informant. Exclusion Criteria: - Immobility or inability to engage in activities that are essential for independent living (e.g., patients with severe dementia); - Any significant medical or psychiatric condition that, in the judgment of the investigators, would potentially interfere with the ability to participate in the study - Major hearing/visual impairment; - Residing in a nursing home or are receiving hospice care; - Inability to communicate in English or Spanish; - Unavailability or unwillingness of the caregiver of the patient to attend the interview. |
Country | Name | City | State |
---|---|---|---|
United States | Baylor College of Medicine | Houston | Texas |
United States | Baylor College of Medicine | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Bijan Najafi, PhD | BioSensics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in baseline burden and stress of caregivers over 6 months | Caregivers burden and stress will be quantified using a 12-item short version of the Zarit Burden Interview (ZBI), which is a validated survey for dementia caregivers. The ZBI questions caregivers experiences in terms of emotional, physical, and social strains or difficulties that result from their role as a caregiver. Items include topics such as feeling one health has suffered, feeling that care affects relationship with family and friends, and how burdened one feels. | Baseline, 3 months and 6 months | |
Primary | Cumulative patient adherence to scheduled tasks over 6 months | Adherence to scheduled tasks will be assessed by Care4AD platform, bi-weekly interview with a caregiver and an ADL log. Adherence is defined by the percentage of compliance to execute pre-defined scheduled activity of daily living tasks (e.g., drinking water, taking medication, attending clinical appointments, etc). | Bi-weekly during the 6 month study | |
Secondary | acceptability, perception of benefit, and ease of use of Care4AD | This will be assessed using technology acceptance model (TAM) survey adopted for telehealth applications | 6 months | |
Secondary | Change in baseline Physical activity at 6 months | Assessed by a validated wearable device called PAMSys (Biosensics LLC, MA, USA) | Baseline and 6 months | |
Secondary | Change from baseline cognitive function at 6 months | Cognitive performance will be assessed using Montreal Cognitive Assessment (MoCA). Scores on the MoCA range from zero to 30, with a score of 26 and higher generally considered normal. | Baseline and 6 months | |
Secondary | Change from baseline Depression at 6 months | We will use a 15-item Geriatric Depression Scale (GDS-15) for screening depressive symptoms. Scores of 0-4 are considered normal, depending on age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression. | Baseline and 6 months | |
Secondary | Change in baseline Quality of life at 6 months: Global PROMIS-10 | Quality of life will be assessed using a validated questionnaire, called Global PROMIS-10.
The adult PROMIS Global Health measure produces two scores: Physical Health and Mental Health. The "7+2" scales include the same global health score plus one fatigue and one pain interference item which are scored independently. |
Baseline and 6 months | |
Secondary | Number of missing doctor visits over 6 month study appointments. | We will document number of missing doctor appointments over 6 months. | During the 6 month study | |
Secondary | Number of Adverse events over 6 month study | Adverse events (e.g., falls, dehydration, urinary tract interaction infection, emergency department visits) over 6 months. | During the 6 month study |
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