Clinical trial NCT04308512: Care Coordination System for People With Dementia
Official title: A Comprehensive Care Coordination and Management Platform for Alzheimer's Disease and Related Dementia (Care4AD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Alzheimer Disease
Dementia
Dementia Alzheimers
Keywords: Alzheimber
Dementia
care coordination
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: BioSensics
First posted: 2020-03-16
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: In this study the investigator will assess the effectiveness of a care coordination device (a supportive care device) called, Care4AD for reducing burden and stress of caregivers, enhancing patient adherence to scheduled tasks, and increasing Individuals with dementia activity (IWD). The investigator will conduct a 6-month prospective randomized control trial (RCT) of 100 persons with mild to moderately severe dementia to examine changes in caregiver's burden and stress and IWD's physical activity and adherence to scheduled ADLs. Feedback (e.g., reminders about completed/incomplete tasks) will be activated in the intervention group (IG) and de-activated in the control group (CG). The investigator will also use an ADL log and bi-weekly phone interview with a caregiver as gold standards to validate the detection of adherence to scheduled ADLs of interest. Furthermore, the acceptability, perception of benefit, and ease of use of Care4AD will be further assessed using technology acceptance model (TAM). We hypothesize that at 6 months, those in the IG compared to the CG will have less caregiver burden (Zarit Burden Interview (ZBI) (primary outcome), greater IWD adherence to scheduled ADLs (primary outcome), and higher IWD physical function and activity (primary outcome). Secondary outcomes will include caregiver coping (Brief Cope), self-efficacy (Revised Scale for Caregiving Self-Efficacy), and preparedness (Preparedness for Caregiving Scale), and quality of life of IWD (Quality of Life in Alzheimer's disease scale)

Eligibility criteria: 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.

Primary outcomes:
measure: Change in baseline burden and stress of caregivers over 6 months
timeFrame: Baseline, 3 months and 6 months
measure: Cumulative patient adherence to scheduled tasks over 6 months
timeFrame: Bi-weekly during the 6 month study
Secondary outcomes:
measure: acceptability, perception of benefit, and ease of use of Care4AD
timeFrame: 6 months
measure: Change in baseline Physical activity at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline cognitive function at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline Depression at 6 months
timeFrame: Baseline and 6 months
measure: Change in baseline Quality of life at 6 months: Global PROMIS-10
timeFrame: Baseline and 6 months
measure: Number of missing doctor visits over 6 month study appointments.
timeFrame: During the 6 month study
measure: Number of Adverse events over 6 month study
timeFrame: During the 6 month study
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References: