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OpenTrials
Completed

NCT Number: NCT04581317

Connecting Seniors to Care

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

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Key information

Conditions

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

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Meals

Other

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

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.

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.

Primary outcomes

  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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • U.S. Administration for Community Living

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 9, 2020
Registry last updated
Jan 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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