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Care Coordination System for People With Dementia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04308512
Recruitment Status : Recruiting
First Posted : March 16, 2020
Last Update Posted : November 29, 2021
BioSensics LLC
Information provided by (Responsible Party):
Bijan Najafi, PhD, Baylor College of Medicine

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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Dementia Dementia Alzheimers Device: Care4AD system Phase 1 Phase 2

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: A Comprehensive Care Coordination and Management Platform for Alzheimer's Disease and Related Dementia (Care4AD)
Actual Study Start Date : November 1, 2021
Estimated Primary Completion Date : May 1, 2023
Estimated Study Completion Date : December 1, 2023

Arm Intervention/treatment
Experimental: Intervention Group (IG): Care coordination with Care4AD system
All participants will receive Care4AD device.All reminders will be activated in the intervention group (IG). Essential activity daily living (ADL) tasks will be pre-programmed by our care coordination expert for the IG. Patients and their caregivers in the IG will be also able to schedule additional tasks.
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.

No Intervention: Control Group (CG): Standard of care
Participants in control group (CG) will also receive Care4AD device. However, all reminders and programming of activity daily living (ADL) tasks will be de-activated in the CG.

Primary Outcome Measures :
  1. Change in baseline burden and stress of caregivers over 6 months [ Time Frame: Baseline, 3 months and 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.

  2. Cumulative patient adherence to scheduled tasks over 6 months [ Time Frame: Bi-weekly during the 6 month study ]
    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).

Secondary Outcome Measures :
  1. acceptability, perception of benefit, and ease of use of Care4AD [ Time Frame: 6 months ]
    This will be assessed using technology acceptance model (TAM) survey adopted for telehealth applications

  2. Change in baseline Physical activity at 6 months [ Time Frame: Baseline and 6 months ]
    Assessed by a validated wearable device called PAMSys (Biosensics LLC, MA, USA)

  3. Change from baseline cognitive function at 6 months [ Time Frame: Baseline and 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.

  4. Change from baseline Depression at 6 months [ Time Frame: Baseline and 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.

  5. Change in baseline Quality of life at 6 months: Global PROMIS-10 [ Time Frame: Baseline and 6 months ]

    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.

  6. Number of missing doctor visits over 6 month study appointments. [ Time Frame: During the 6 month study ]
    We will document number of missing doctor appointments over 6 months.

  7. Number of Adverse events over 6 month study [ Time Frame: During the 6 month study ]
    Adverse events (e.g., falls, dehydration, urinary tract interaction infection, emergency department visits) over 6 months.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04308512

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Contact: Maria Noun, BS 713-798-7538
Contact: Ilse Torres 713-798-8714

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United States, Texas
Baylor College of Medicine Active, not recruiting
Houston, Texas, United States, 77030
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Maria Noun    713-798-7538   
Sponsors and Collaborators
Bijan Najafi, PhD
BioSensics LLC
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Responsible Party: Bijan Najafi, PhD, Professor of Surgery, Baylor College of Medicine Identifier: NCT04308512    
Other Study ID Numbers: H-46087
First Posted: March 16, 2020    Key Record Dates
Last Update Posted: November 29, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bijan Najafi, PhD, Baylor College of Medicine:
care coordination
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders