Skip to content

Connecting Seniors to Care

Connecting Seniors to Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04581317
Enrollment
53
Registered
2020-10-09
Start date
2021-01-19
Completion date
2022-12-31
Last updated
2023-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia

Keywords

nutrition, virtual assistant device, frailty, social determinants of health

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

Interventions

OTHERmeals

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

OTHERAES 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.

OTHERAES 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.

Sponsors

U.S. Administration for Community Living
CollaboratorUNKNOWN
The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Feasibility as measured by the technology acceptance measure (TAM)12 weeks from baselineThe TAM has 4 questions each one with five answer choices ranging form Strongly Agree to Strongly Disagree

Secondary

MeasureTime frameDescription
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)Baseline,18 weeksThe 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)Baseline,18 weeksTotal 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)Baseline,18 weeks
Change in Caregiver burden as measured by the Zarit Caregiver Burden Interview (ZCBI)Baseline,18 weeksThe ZCBI has 22 questions with a score ranging from 0-88, a higher score indicating more burden

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026