Connecting Seniors to Care

Dementia Clinical Trial

Official title:

Connecting Seniors to Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04581317
• Other study ID #: HSC-MS-20-0857
• Status: Completed
• Phase: N/A
• Start date: January 19, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 31, 2022
• Est. primary completion date: September 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dementia

Intervention

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

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in social determinants of health as measured by the the Mental Health Screening/Assessment (MHS)		Baseline,18 weeks
Secondary	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
Secondary	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
Secondary	Change in nutritional status as measured by the Nutrition Screening Initiative (NSI)		Baseline,18 weeks
Secondary	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