Connecting Seniors to Care

NCT04581317 | Completed DMC

• 1 other identifier: HSC-MS-20-0857
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Dementia

Keywords

nutrition; virtual assistant device; frailty; social determinants of health

Outcome Measures

Primary Outcomes (2)

• 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

  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

  18 weeks from baseline

Secondary Outcomes (5)

• Change in social determinants of health as measured by the the Mental Health Screening/Assessment (MHS)

  Baseline,18 weeks

• Change in Depression as measured by the Center for Epidemiologic Studies Depression Scale (CES-D)

  Baseline,18 weeks

• Change in cognitive impairment as measured by the Montreal Cognitive Assessment (MOCA)

  Baseline,18 weeks

• Change in nutritional status as measured by the Nutrition Screening Initiative (NSI)

  Baseline,18 weeks

• Change in Caregiver burden as measured by the Zarit Caregiver Burden Interview (ZCBI)

  Baseline,18 weeks

Study Arms (3)

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.

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

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

Other: meals; Other: AES 8 advanced usage

Interventions

meals OTHER

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

Phase 1 (meals only); Phase 2 (Meals + Amazon Echo Show 8 (AES 8) basic usage); Phase 3 (meals + AES 8 advanced )

AES 8 basic usage 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 2 (Meals + Amazon Echo Show 8 (AES 8) basic usage)

AES 8 advanced usage 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.

Phase 3 (meals + AES 8 advanced )

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• U.S. Administration for Community Living: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 39792590 DERIVED

MeSH Terms

Conditions

Dementia; Frailty

Interventions

Meals

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Jessica Lee

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 2, 2020
• First Posted: October 9, 2020
• Study Start: January 19, 2021
• Primary Completion: September 29, 2022
• Study Completion: December 31, 2022
• Last Updated: January 11, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)