Care Coordination System for People With Dementia

Alzheimer Disease Clinical Trial

Official title:

A Comprehensive Care Coordination and Management Platform for Alzheimer's Disease and Related Dementia (Care4AD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04308512
• Other study ID #: H-46087
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 1, 2021
• Est. completion date: December 1, 2024

Study information

• Verified date: October 2023
• Source: Baylor College of Medicine
• Contact: Maria Noun, BS
• Phone: 713-798-7538
• Email: maria.noun[@]bcm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Dementia Alzheimers

Intervention

Device:
• Care4AD system
Eligible subjects will be randomized to intervention, IG, and control groups, CG, with ratio of 1:1 and will be assessed at baseline and six months. All reminders will be activated in the intervention group and de-activated in the control group. Essential ADL tasks will be preprogrammed by our care coordination expert for the IG. Patients and their caregivers in the IG will be also able to schedule additional tasks.

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas
United States	Baylor College of Medicine	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Bijan Najafi, PhD	BioSensics

Country where clinical trial is conducted

United States, 

Outcome

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