- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04308512
Care Coordination System for People With Dementia
June 21, 2024 updated by: Bijan Najafi, PhD
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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)
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Maria Noun, BS
- Phone Number: 713-798-7538
- Email: maria.noun@bcm.edu
Study Contact Backup
- Name: Ilse Torres
- Phone Number: 713-798-8714
- Email: ilse.torresruiz@bcm.edu
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- Baylor College of Medicine
-
Contact:
- Maria Noun
- Phone Number: 713-798-7538
- Email: maria.noun@bcm.edu
-
Houston, Texas, United States, 77030
- Active, not recruiting
- Baylor College of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, 3 months and 6 months
|
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).
|
Bi-weekly during the 6 month study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
6 months
|
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)
|
Baseline and 6 months
|
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.
|
Baseline and 6 months
|
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.
|
Baseline and 6 months
|
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. |
Baseline and 6 months
|
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.
|
During the 6 month study
|
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.
|
During the 6 month study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2021
Primary Completion (Estimated)
May 1, 2025
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
March 10, 2020
First Submitted That Met QC Criteria
March 13, 2020
First Posted (Actual)
March 16, 2020
Study Record Updates
Last Update Posted (Actual)
June 25, 2024
Last Update Submitted That Met QC Criteria
June 21, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-46087
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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