Connecting Seniors to Care

January 9, 2023 updated by: Jessica Lee, The University of Texas Health Science Center, Houston
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

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

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: meals
Participants will receive meals delivered to them by the Meals oN wheels(MOW) program for 6 weeks.
Experimental: Phase 2 (Meals + Amazon Echo Show 8 (AES 8) basic usage)
Participants will have meals delivered and the AES device installed for basic usage
Other: meals
Participants will receive meals delivered to them by the Meals oN wheels(MOW) program for 6 weeks.
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.
Experimental: Phase 3 (meals + AES 8 advanced )
Participants will have meals delivered and the AES device installed for advanced usage
Other: meals
Participants will receive meals delivered to them by the Meals oN wheels(MOW) program for 6 weeks.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks from baseline
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
18 weeks from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in social determinants of health as measured by the the Mental Health Screening/Assessment (MHS)
Time Frame: Baseline,18 weeks
Baseline,18 weeks
Change in Depression as measured by the Center for Epidemiologic Studies Depression Scale (CES-D)
Time Frame: Baseline,18 weeks
The scale consists of 20 questions and each is scored from 0-4,a higher number indicating more depression
Baseline,18 weeks
Change in cognitive impairment as measured by the Montreal Cognitive Assessment (MOCA)
Time Frame: Baseline,18 weeks
Total score on the Montreal Cognitive Assessment (MoCA) range from 0 to 30, with a higher score indicating a better outcome.
Baseline,18 weeks
Change in nutritional status as measured by the Nutrition Screening Initiative (NSI)
Time Frame: Baseline,18 weeks
Baseline,18 weeks
Change in Caregiver burden as measured by the Zarit Caregiver Burden Interview (ZCBI)
Time Frame: Baseline,18 weeks
The ZCBI has 22 questions with a score ranging from 0-88, a higher score indicating more burden
Baseline,18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

U.S. Administration for Community Living

Investigators

  • Principal Investigator: Jessica Lee, The University of Texas Health Science Center, Houston

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)

January 19, 2021

Primary Completion (Actual)

September 29, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

October 2, 2020

First Submitted That Met QC Criteria

October 2, 2020

First Posted (Actual)

October 9, 2020

Study Record Updates

Last Update Posted (Estimate)

January 11, 2023

Last Update Submitted That Met QC Criteria

January 9, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-20-0857

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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