Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
53 participants
INTERVENTIONAL
2021-01-19
2022-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Use of Socially Assistive Robots for Long Term Care Older Adults With Cognitive Impairment and Apathy
NCT05178992
Tele-BA for Home-Delivered Meals Clients
NCT04131790
Telephone Calls for Health for Homebound Older Adults
NCT04595708
Cognitive Screening and Cognitive Training in Seniors
NCT02588209
Home-Based Assessment for Alzheimer Disease Prevention
NCT00546767
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Phase 1 (meals only)
Participants will receive meals delivered to them by the Meals oN wheels(MOW) program for 6 weeks.MOW will once a week deliver in-person enough frozen meals to cover lunch for 5 days and breakfast for 7 days. Study staff will call the participants twice a week to ask 5 questions about their health, mood, and meal consumption.At the end of the 6 weeks, a study team member will make an in-person visit to the participants' homes to measure Fried Frailty Phenotype(FFP), MHS, CES-D, MOCA, Activities of Daily Living (ADL)/Instrumental activities of daily living(IADL)s, NSI, and ZCBI. Caregivers will not receive meals during this first phase as the focus is on the nutritional status of the cognitively impaired older adult.
meals
Participants will receive meals delivered to them by the Meals oN wheels(MOW) program for 6 weeks.
Phase 2 (Meals + Amazon Echo Show 8 (AES 8) basic usage)
Participants will have meals delivered and the AES device installed for basic usage
meals
Participants will receive meals delivered to them by the Meals oN wheels(MOW) program for 6 weeks.
AES 8 basic usage
For the second 6 weeks, participants will continue to have meal deliveries and will now have the AES 8 device which can be used by the cognitively impaired participant and their caregiver. AES 8 devices will be installed in participant's homes by the study team and participants will be given basic instructions on using the device as well as a one-page handout that will include instructions on how to use and maintain privacy with their device. The study staff will continue to call twice a week to ask the 5 questions. At the end of the 6 weeks, a study team member will make an in-person visit to the participants' homes to measure FFP, MHS, CES-D, MOCA, ADL/IADLs, NSI, ZCBI, and TAM.
Phase 3 (meals + AES 8 advanced )
Participants will have meals delivered and the AES device installed for advanced usage
meals
Participants will receive meals delivered to them by the Meals oN wheels(MOW) program for 6 weeks.
AES 8 advanced usage
In the third 6 weeks, the participants will continue to have meal deliveries and the AES 8 will be upgraded to provide an active intervention by asking the twice a week 5 questions through the device. The questions should be answered by the cognitively impaired older adult using the device, though the caregiver can still use the device for other basic services. The participant will be able to answer the questions verbally or by touch screen options displayed on the device.At the end of the 6 weeks, a study team member will make an in-person visit to the participants' homes to measure FFP, MHS, CES-D, MOCA, ADL/IADLs, NSI, ZCBI, and TAM.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
meals
Participants will receive meals delivered to them by the Meals oN wheels(MOW) program for 6 weeks.
AES 8 basic usage
For the second 6 weeks, participants will continue to have meal deliveries and will now have the AES 8 device which can be used by the cognitively impaired participant and their caregiver. AES 8 devices will be installed in participant's homes by the study team and participants will be given basic instructions on using the device as well as a one-page handout that will include instructions on how to use and maintain privacy with their device. The study staff will continue to call twice a week to ask the 5 questions. At the end of the 6 weeks, a study team member will make an in-person visit to the participants' homes to measure FFP, MHS, CES-D, MOCA, ADL/IADLs, NSI, ZCBI, and TAM.
AES 8 advanced usage
In the third 6 weeks, the participants will continue to have meal deliveries and the AES 8 will be upgraded to provide an active intervention by asking the twice a week 5 questions through the device. The questions should be answered by the cognitively impaired older adult using the device, though the caregiver can still use the device for other basic services. The participant will be able to answer the questions verbally or by touch screen options displayed on the device.At the end of the 6 weeks, a study team member will make an in-person visit to the participants' homes to measure FFP, MHS, CES-D, MOCA, ADL/IADLs, NSI, ZCBI, and TAM.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* are on the IMGH MOW waiting list
* medically stable
Exclusion Criteria
* have a pre-diagnosed terminal illness
* unable to ambulate, and/or are unable to use their upper extremities.
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
U.S. Administration for Community Living
UNKNOWN
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jessica Lee
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jessica Lee
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Nunez M, Patel P, Ulin L, Kian L, Cominsky M, Burnett J, Lee JL. Feasibility and Usage of a Virtual Assistant Device in Cognitively Impaired Homebound Older Adults. J Appl Gerontol. 2025 Oct;44(10):1651-1660. doi: 10.1177/07334648251314284. Epub 2025 Jan 10.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HSC-MS-20-0857
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.