Connecting Seniors to Care

NCT ID: NCT04581317

Last Updated: 2023-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-19

Study Completion Date

2022-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Dementia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

meals

Intervention Type OTHER

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

Group Type EXPERIMENTAL

meals

Intervention Type OTHER

Participants will receive meals delivered to them by the Meals oN wheels(MOW) program for 6 weeks.

AES 8 basic usage

Intervention Type OTHER

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

Group Type EXPERIMENTAL

meals

Intervention Type OTHER

Participants will receive meals delivered to them by the Meals oN wheels(MOW) program for 6 weeks.

AES 8 advanced usage

Intervention Type OTHER

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

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meals

Participants will receive meals delivered to them by the Meals oN wheels(MOW) program for 6 weeks.

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* do not have cognitive impairment
* have a pre-diagnosed terminal illness
* unable to ambulate, and/or are unable to use their upper extremities.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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U.S. Administration for Community Living

UNKNOWN

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Jessica Lee

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jessica Lee

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 39792590 (View on PubMed)

Other Identifiers

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HSC-MS-20-0857

Identifier Type: -

Identifier Source: org_study_id

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