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Care Coordination System for People With Dementia

Primary Purpose

Alzheimer Disease, Dementia, Dementia Alzheimers

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Care4AD system
Sponsored by
Bijan Najafi, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Alzheimer Disease focused on measuring Alzheimber, Dementia, care coordination

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Baylor College of Medicine
  • Baylor College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group (IG): Care coordination with Care4AD system

Control Group (CG): Standard of care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

acceptability, perception of benefit, and ease of use of Care4AD
This will be assessed using technology acceptance model (TAM) survey adopted for telehealth applications
Change in baseline Physical activity at 6 months
Assessed by a validated wearable device called PAMSys (Biosensics LLC, MA, USA)
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.
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.
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.
Number of missing doctor visits over 6 month study appointments.
We will document number of missing doctor appointments over 6 months.
Number of Adverse events over 6 month study
Adverse events (e.g., falls, dehydration, urinary tract interaction infection, emergency department visits) over 6 months.

Full Information

First Posted
March 10, 2020
Last Updated
October 10, 2023
Sponsor
Bijan Najafi, PhD
Collaborators
BioSensics
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1. Study Identification

Unique Protocol Identification Number
NCT04308512
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bijan Najafi, PhD
Collaborators
BioSensics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Dementia, Dementia Alzheimers
Keywords
Alzheimber, Dementia, care coordination

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group (IG): Care coordination with Care4AD system
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group (CG): Standard of care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Care4AD system
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in baseline burden and stress of caregivers over 6 months
Description
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.
Time Frame
Baseline, 3 months and 6 months
Title
Cumulative patient adherence to scheduled tasks over 6 months
Description
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).
Time Frame
Bi-weekly during the 6 month study
Secondary Outcome Measure Information:
Title
acceptability, perception of benefit, and ease of use of Care4AD
Description
This will be assessed using technology acceptance model (TAM) survey adopted for telehealth applications
Time Frame
6 months
Title
Change in baseline Physical activity at 6 months
Description
Assessed by a validated wearable device called PAMSys (Biosensics LLC, MA, USA)
Time Frame
Baseline and 6 months
Title
Change from baseline cognitive function at 6 months
Description
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.
Time Frame
Baseline and 6 months
Title
Change from baseline Depression at 6 months
Description
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.
Time Frame
Baseline and 6 months
Title
Change in baseline Quality of life at 6 months: Global PROMIS-10
Description
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.
Time Frame
Baseline and 6 months
Title
Number of missing doctor visits over 6 month study appointments.
Description
We will document number of missing doctor appointments over 6 months.
Time Frame
During the 6 month study
Title
Number of Adverse events over 6 month study
Description
Adverse events (e.g., falls, dehydration, urinary tract interaction infection, emergency department visits) over 6 months.
Time Frame
During the 6 month study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Noun, BS
Phone
713-798-7538
Email
maria.noun@bcm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ilse Torres
Phone
713-798-8714
Email
ilse.torresruiz@bcm.edu
Facility Information:
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Noun
Phone
713-798-7538
Email
maria.noun@bcm.edu

12. IPD Sharing Statement

Learn more about this trial

Care Coordination System for People With Dementia

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