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Connecting Seniors to Care

Primary Purpose

Dementia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
meals
AES 8 basic usage
AES 8 advanced usage
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia focused on measuring nutrition, virtual assistant device, frailty, social determinants of health

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Phase 1 (meals only)

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

Phase 3 (meals + AES 8 advanced )

Arm Description

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.

Participants will have meals delivered and the AES device installed for basic usage

Participants will have meals delivered and the AES device installed for advanced usage

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Change in social determinants of health as measured by the the Mental Health Screening/Assessment (MHS)
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
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.
Change in nutritional status as measured by the Nutrition Screening Initiative (NSI)
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

Full Information

First Posted
October 2, 2020
Last Updated
January 9, 2023
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
U.S. Administration for Community Living
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1. Study Identification

Unique Protocol Identification Number
NCT04581317
Brief Title
Connecting Seniors to Care
Official Title
Connecting Seniors to Care
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 19, 2021 (Actual)
Primary Completion Date
September 29, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
U.S. Administration for Community Living

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
nutrition, virtual assistant device, frailty, social determinants of health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase 1 (meals only)
Arm Type
Experimental
Arm Description
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.
Arm Title
Phase 2 (Meals + Amazon Echo Show 8 (AES 8) basic usage)
Arm Type
Experimental
Arm Description
Participants will have meals delivered and the AES device installed for basic usage
Arm Title
Phase 3 (meals + AES 8 advanced )
Arm Type
Experimental
Arm Description
Participants will have meals delivered and the AES device installed for advanced usage
Intervention Type
Other
Intervention Name(s)
meals
Intervention Description
Participants will receive meals delivered to them by the Meals oN wheels(MOW) program for 6 weeks.
Intervention Type
Other
Intervention Name(s)
AES 8 basic usage
Intervention Description
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
Intervention Name(s)
AES 8 advanced usage
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility as measured by the technology acceptance measure (TAM)
Description
The TAM has 4 questions each one with five answer choices ranging form Strongly Agree to Strongly Disagree
Time Frame
12 weeks from baseline
Title
Feasibility as measured by the technology acceptance measure (TAM)
Description
The TAM has 4 questions each one with five answer choices ranging form Strongly Agree to Strongly Disagree
Time Frame
18 weeks from baseline
Secondary Outcome Measure Information:
Title
Change in social determinants of health as measured by the the Mental Health Screening/Assessment (MHS)
Time Frame
Baseline,18 weeks
Title
Change in Depression as measured by the Center for Epidemiologic Studies Depression Scale (CES-D)
Description
The scale consists of 20 questions and each is scored from 0-4,a higher number indicating more depression
Time Frame
Baseline,18 weeks
Title
Change in cognitive impairment as measured by the Montreal Cognitive Assessment (MOCA)
Description
Total score on the Montreal Cognitive Assessment (MoCA) range from 0 to 30, with a higher score indicating a better outcome.
Time Frame
Baseline,18 weeks
Title
Change in nutritional status as measured by the Nutrition Screening Initiative (NSI)
Time Frame
Baseline,18 weeks
Title
Change in Caregiver burden as measured by the Zarit Caregiver Burden Interview (ZCBI)
Description
The ZCBI has 22 questions with a score ranging from 0-88, a higher score indicating more burden
Time Frame
Baseline,18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Lee
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Connecting Seniors to Care

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