Reducing COVID-19 Related Disability in Rural Community-Dwelling Older Adults Using Smart Technology

Sponsor

University of Missouri-Columbia (Other)

Overall Status

Recruiting

CT.gov ID

NCT05379504

Collaborator

National Institute on Aging (NIA) (NIH)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The social distancing requirements for COVID-19 coupled with the adverse health impacts of social isolation and decreased access to healthcare in rural areas places older adults with disabilities in a dire situation. The smart sensor system to be deployed and studied in this project aims to reduce disability for rural community-dwelling older adults and improve health-related quality of life, including depression and anxiety. An implementation guide will be developed to increase success of future scale-up evaluations.

Condition or Disease	Intervention/Treatment	Phase
Quality of Life Disabilities Multiple	Behavioral: Standard Health Education Behavioral: Self Management	N/A

Detailed Description

Over 85% of Missouri is rural and individuals in these rural areas are older and have reduced access to regular healthcare as compared to individuals living in urban areas of Missouri. Those with disabilities, particularly older adults, are at higher risk for contracting COVID-19. There is a critical need to reduce disability and improve quality of life for community-dwelling older adults with disabilities for successful aging-in-place during the COVID-19 pandemic. We have developed, with our partner company Foresite Healthcare, a proven sensor-based technology solution for monitoring health-related behaviors in the home. In a multi-site randomized controlled trial, we demonstrated that the sensor system with nursing care coordination prevents declines in function for older adults living in assisted living facilities. The long-term goal of this research is to support independent living for older adults with disabilities for as long as possible. The purpose of this project is to deploy the sensor system in the homes of rural community-dwelling older adults with disabilities and evaluate the effect of the sensor system on reducing disability and improving health-related quality of life. Using a two-arm randomized controlled trial, the sensor system will be installed in the homes of 64 older adults. Participants randomized to Study Arm 1 will receive a multidisciplinary (nursing, occupational therapy, and social work) self-management intervention paired with the sensor system. This intervention is based on the 5As self-management approach and is a direct translation of the nursing care coordination in our prior research. Participants randomized to Study Arm 2 will have standard health education paired with the sensor system. An implementation guide for future use with different partner agencies will be developed using individual and setting level data collected from Aims 1, 2 and 3 using the RE-AIM framework. The project will be accomplished in three aims. In Aim 1, we evaluate the effect of a sensor system paired with a multidisciplinary self-management intervention as compared to the sensor system paired with standard health education care on disability and health-related quality of life after 1 year. In Aim 2, we will evaluate the effect of the sensor system on secondary health outcomes (depression, anxiety, occupational performance, and caregiver burden), rates of falls, and healthcare usage. In Aim 3, we will collect individual participant data for satisfaction and adoption and stakeholder data about organizational setting. Data from Aims 1, 2 and 3 will be analyzed using RE-AIM to produce implementation guidance contextualized by organizational setting. For older adults with disabilities living in rural areas, the sensor system has the potential to change the approach to healthcare and disability management.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Individuals will be randomized to one of two study arms in blocks of 4.Individuals will be randomized to one of two study arms in blocks of 4.

Masking:

Single (Outcomes Assessor)

Masking Description:

Outcomes assessor will be masked to study participant assignment. Baseline assessments will be completed prior to enrollment.

Primary Purpose:

Treatment

Official Title:

Reducing COVID-19 Related Disability in Rural Community-Dwelling Older Adults Using Smart Technology

Actual Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Self Management The 5A's Behavior Change Mode [39] is the framework for the self-management intervention. The five "A"s will be addressed through the integration of the self-management intervention and the sensor system. There will be a minimum of four intervention sessions with each healthcare profession (OT, RN, and SW) for 12 visits per participant.	Behavioral: Self Management The self-management intervention will be delivered over the course of a year. There will be a minimum of four intervention sessions with each healthcare profession (OT, RN and SW) for 12 visits per participant. The team (OT, RN and SW) will meet twice during the first 2 months to determine a lead interventionist based on the participant's SMART goals and areas of concern. The lead interventionist will have three additional sessions with the participant and will be the point-person for sensor system alerts and messages. Goal Attainment Scaling [83] will be administered during the quarterly interview to assess participant progress on SMART goals. This measure is administered collectively with the participant, provides further accountability, offers opportunities to the participant for reflection on progress, and is a concrete measure of "success" of the self-management intervention.
Active Comparator: Health Education Participant's randomized to the standard health education arm will receive the intervention at Month 1 and then months 3, 6, 9 and 12.	Behavioral: Standard Health Education Participants randomized to the standard health education arm will receive the intervention at month 1 and then months 3, 6, 9, and 12 (coinciding with the quarterly interviews). The participant will use the tablet and telehealth platform to complete the interview and education session with research staff. The content of these sessions will be focused on helping the participant (and family member/caregiver as appropriate) understand their health data, assisting them with any technology issues and providing the participant with education on their condition(s) and any requested resources. Research staff will will also provide any additional health education if there are changes to conditions or new diagnoses after an outside provider visit.

Arm

Intervention/Treatment

Experimental: Self Management

The 5A's Behavior Change Mode [39] is the framework for the self-management intervention. The five "A"s will be addressed through the integration of the self-management intervention and the sensor system. There will be a minimum of four intervention sessions with each healthcare profession (OT, RN, and SW) for 12 visits per participant.

Behavioral: Self Management

The self-management intervention will be delivered over the course of a year. There will be a minimum of four intervention sessions with each healthcare profession (OT, RN and SW) for 12 visits per participant. The team (OT, RN and SW) will meet twice during the first 2 months to determine a lead interventionist based on the participant's SMART goals and areas of concern. The lead interventionist will have three additional sessions with the participant and will be the point-person for sensor system alerts and messages. Goal Attainment Scaling [83] will be administered during the quarterly interview to assess participant progress on SMART goals. This measure is administered collectively with the participant, provides further accountability, offers opportunities to the participant for reflection on progress, and is a concrete measure of "success" of the self-management intervention.

Active Comparator: Health Education

Participant's randomized to the standard health education arm will receive the intervention at Month 1 and then months 3, 6, 9 and 12.

Behavioral: Standard Health Education

Participants randomized to the standard health education arm will receive the intervention at month 1 and then months 3, 6, 9, and 12 (coinciding with the quarterly interviews). The participant will use the tablet and telehealth platform to complete the interview and education session with research staff. The content of these sessions will be focused on helping the participant (and family member/caregiver as appropriate) understand their health data, assisting them with any technology issues and providing the participant with education on their condition(s) and any requested resources. Research staff will will also provide any additional health education if there are changes to conditions or new diagnoses after an outside provider visit.

Outcome Measures

Primary Outcome Measures

Change in Katz ADL Index [1 year]
Disability
Change in PROMIS-29 [1 year]
Health-related quality of life

Secondary Outcome Measures

Change in Hospital Anxiety and Depression Scale [1 year]
Depression and anxiety
Change in Canadian Occupational Performance Measure [1 year]
Occupational performance
Change in Patient Activation Measure [1 year]
Patient activation/self-efficacy
Technology Experience Profile [Baseline]
Experience with technology

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Over the age of 65, Live in a rural defined county, Have difficulty with at least 1 self-care task or 2 daily living tasks, Have internet access, Able to stand with or without assistance

Exclusion Criteria:

Life expectancy less than one year, Severe cognitive impairment (mini mental state exam score <17), Life in a facility that provides care services, Katz ADL Score of 6, Receiving in-home physical therapy, occupational therapy or nursing, Have been hospitalized more than three times in teh previous 12 months, Plan to change residences within the next year

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Missouri	Columbia	Missouri	United States	65211

Sponsors and Collaborators

University of Missouri-Columbia
National Institute on Aging (NIA)

Investigators

Principal Investigator: Rachel M Proffitt, OTD, University of Missouri-Columbia

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Rachel Proffitt, Principal Investigator, University of Missouri-Columbia

ClinicalTrials.gov Identifier:

NCT05379504

Other Study ID Numbers:

2043542
1R01AG072935-01A1

First Posted:

May 18, 2022

Last Update Posted:

Jul 26, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 26, 2022