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Connecting Seniors to Care

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ClinicalTrials.gov Identifier: NCT04581317
Recruitment Status : Recruiting
First Posted : October 9, 2020
Last Update Posted : December 17, 2021
Sponsor:
Collaborator:
U.S. Administration on Community Living
Information provided by (Responsible Party):
Jessica Lee, The University of Texas Health Science Center, Houston

Study Description
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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

Condition or disease Intervention/treatment Phase
Dementia Other: meals Other: AES 8 basic usage Other: AES 8 advanced usage Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Connecting Seniors to Care
Actual Study Start Date : January 19, 2021
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 31, 2022
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. Time spent on each feature of the Amazon Echo Show 8 (AES8) device [ Time Frame: 12 weeks from baseline ]
    analyzed via each unique and anonymous AES 8 device identifier

  4. Time spent on each feature of the AES8 device [ Time Frame: 18 weeks from baseline ]
    analyzed via each unique and anonymous AES 8 device identifier


Secondary Outcome Measures :
  1. Change in social determinants of health as measured by the the Mental Health Screening/Assessment (MHS) [ Time Frame: Baseline,18 weeks ]
  2. 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

  3. 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.

  4. Change in nutritional status as measured by the Nutrition Screening Initiative (NSI) [ Time Frame: Baseline,18 weeks ]
  5. 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


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04581317


Contacts
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Contact: Jessica Lee (713) 500-5457 Jessica.Lee@uth.tmc.edu
Contact: Kim N Johnson (713) 500-6295 Kim.N.Johnson@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Jessica Lee    713-500-5457    Jessica.Lee@uth.tmc.edu   
Contact: Kim N Johnson    (713) 500-6295    Kim.N.Johnson@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
U.S. Administration on Community Living
Investigators
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Principal Investigator: Jessica Lee The University of Texas Health Science Center, Houston
More Information
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Responsible Party: Jessica Lee, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT04581317    
Other Study ID Numbers: HSC-MS-20-0857
First Posted: October 9, 2020    Key Record Dates
Last Update Posted: December 17, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jessica Lee, The University of Texas Health Science Center, Houston:
nutrition
virtual assistant device
frailty
social determinants of health
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Neurocognitive Disorders
Mental Disorders