Connecting Seniors to Care

Study Overview
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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

Official Title
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Connecting Seniors to Care

Conditions
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Dementia

Intervention / Treatment
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* Other: meals
* Other: AES 8 basic usage
* Other: AES 8 advanced usage


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phase 1 (meals only)<br>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<br>* Participants will receive meals delivered to them by the Meals oN wheels(MOW) program for 6 weeks.<br>|
| Experimental: Phase 2 (Meals + Amazon Echo Show 8 (AES 8) basic usage)<br>Participants will have meals delivered and the AES device installed for basic usage | Other: meals<br>* Participants will receive meals delivered to them by the Meals oN wheels(MOW) program for 6 weeks.<br>Other: AES 8 basic usage<br>* 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.<br>|
| Experimental: Phase 3 (meals + AES 8 advanced )<br>Participants will have meals delivered and the AES device installed for advanced usage | Other: meals<br>* Participants will receive meals delivered to them by the Meals oN wheels(MOW) program for 6 weeks.<br>Other: AES 8 advanced usage<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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) |  | Baseline,18 weeks | 
| 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 | Baseline,18 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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frailty, nutrition, virtual assistant device, social determinants of health