DementiaNCT04581317
Connecting Seniors to Care
A study testing meals, AES 8 basic usage and AES 8 advanced usage in people with Dementia, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to assess the feasibility of implementing the virtual assistant devices into the daily routine of participants and their caregivers,to measure social determinants of health,depression,cognitive impairment,nutritional and functional status in the cognitively impaired participants Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- meals, AES 8 basic usage and AES 8 advanced usage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cognitive impairment as reported in the Mental Health Screening/Assessment section on the Interfaith Ministries of Greater Houston's Meals on Wheels Program (IMGH MOW) intake form
- are on the IMGH MOW waiting list
- medically stable
Who cannot join
- do not have cognitive impairment
- have a pre-diagnosed terminal illness
- unable to ambulate, and/or are unable to use their upper extremities.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
The purpose of this study is to assess the feasibility of implementing the virtual assistant devices into the daily routine of participants and their caregivers,to measure social determinants of health,depression,cognitive impairment,nutritional and functional status in the cognitively impaired participants
- Conditions
- Dementia
- Being tested
- meals, AES 8 basic usage, AES 8 advanced usage
- Keywords
- nutrition, virtual assistant device, frailty, social determinants of health
- Medical subject headings
- Dementia, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mealsOther
Participants will receive meals delivered to them by the Meals oN wheels(MOW) program for 6 weeks.
AES 8 basic usageOther
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 usageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 (meals only) | Experimental | 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. Receives: Other: meals |
| Phase 2 (Meals + Amazon Echo Show 8 (AES 8) basic usage) | Experimental | Participants will have meals delivered and the AES device installed for basic usage Receives: Other: meals; Other: AES 8 basic usage |
| Phase 3 (meals + AES 8 advanced ) | Experimental | Participants will have meals delivered and the AES device installed for advanced usage Receives: Other: meals; Other: AES 8 advanced usage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as measured by the technology acceptance measure (TAM)
The TAM has 4 questions each one with five answer choices ranging form Strongly Agree to Strongly Disagree
Measured: 12 weeks from baseline
Feasibility as measured by the technology acceptance measure (TAM)
The TAM has 4 questions each one with five answer choices ranging form Strongly Agree to Strongly Disagree
Measured: 18 weeks from baseline
Secondary outcomes (5)
Change in social determinants of health as measured by the the Mental Health Screening/Assessment (MHS)
Measured: Baseline,18 weeks
Change in Depression as measured by the Center for Epidemiologic Studies Depression Scale (CES-D)
The scale consists of 20 questions and each is scored from 0-4,a higher number indicating more depression
Measured: Baseline,18 weeks
Change in cognitive impairment as measured by the Montreal Cognitive Assessment (MOCA)
Total score on the Montreal Cognitive Assessment (MoCA) range from 0 to 30, with a higher score indicating a better outcome.
Measured: Baseline,18 weeks
Change in nutritional status as measured by the Nutrition Screening Initiative (NSI)
Measured: Baseline,18 weeks
Change in Caregiver burden as measured by the Zarit Caregiver Burden Interview (ZCBI)
The ZCBI has 22 questions with a score ranging from 0-88, a higher score indicating more burden
Measured: Baseline,18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start19 Jan 2021
- Primary completion29 Sep 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Administration for Community Living
- Responsible party
- Principal investigator, Jessica Lee, The University of Texas Health Science Center, Houston
- Investigators
- Jessica Lee, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04581317
- Sponsor's protocol ID
- HSC-MS-20-0857
- Status last verified
- Jan 2023
- First submitted
- 2 Oct 2020
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39792590
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connecting Seniors to Care
- ClinicalTrials.gov ID
- NCT04581317
- Acronym / sponsor ID
- HSC-MS-20-0857
- Conditions
- Dementia
- Keywords
- nutrition, virtual assistant device, frailty, social determinants of health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- U.S. Administration for Community Living
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- 29 Sep 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 9 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the feasibility of implementing the virtual assistant devices into the daily routine of participants and their caregivers,to measure social determinants of health,depression,cognitive impairment,nutritional and functional status in the cognitively impaired participants
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1 (meals only) | Experimental | Other: mealsParticipants 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. |
| Phase 2 (Meals + Amazon Echo Show 8 (AES 8) basic usage) | Experimental | Other: meals, Other: AES 8 basic usageParticipants will have meals delivered and the AES device installed for basic usage |
| Phase 3 (meals + AES 8 advanced ) | Experimental | Other: meals, Other: AES 8 advanced usageParticipants will have meals delivered and the AES device installed for advanced usage |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- cognitive impairment as reported in the Mental Health Screening/Assessment section on the Interfaith Ministries of Greater Houston's Meals on Wheels Program (IMGH MOW) intake form
- are on the IMGH MOW waiting list
- medically stable
Key exclusion criteria (3 listed)
- do not have cognitive impairment
- have a pre-diagnosed terminal illness
- unable to ambulate, and/or are unable to use their upper extremities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mealsParticipants will receive meals delivered to them by the Meals oN wheels(MOW) program for 6 weeks. | Other | Phase 1 (meals only), Phase 2 (Meals + Amazon Echo Show 8 (AES 8) basic usage), Phase 3 (meals + AES 8 advanced ) |
| AES 8 basic usageFor 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. | Other | Phase 2 (Meals + Amazon Echo Show 8 (AES 8) basic usage) |
| AES 8 advanced usageIn 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. | Other | Phase 3 (meals + AES 8 advanced ) |
Primary outcome
Feasibility as measured by the technology acceptance measure (TAM)
Time frame: 12 weeks from baseline
The TAM has 4 questions each one with five answer choices ranging form Strongly Agree to Strongly Disagree
Feasibility as measured by the technology acceptance measure (TAM)
Time frame: 18 weeks from baseline
The TAM has 4 questions each one with five answer choices ranging form Strongly Agree to Strongly Disagree
5 secondary outcomes
Change in social determinants of health as measured by the the Mental Health Screening/Assessment (MHS)
Time frame: Baseline,18 weeks
Change in Depression as measured by the Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: Baseline,18 weeks
Change in cognitive impairment as measured by the Montreal Cognitive Assessment (MOCA)
Time frame: Baseline,18 weeks
Change in nutritional status as measured by the Nutrition Screening Initiative (NSI)
Time frame: Baseline,18 weeks
Change in Caregiver burden as measured by the Zarit Caregiver Burden Interview (ZCBI)
Time frame: Baseline,18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Derived from this study: PubMed 39792590Nunez 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Lee principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing meals, AES 8 basic usage and AES 8 advanced usage in people with Dementia, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as measured by the technology acceptance measure (TAM) (time frame: 12 weeks from baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04581317, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023.