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

Primary Purpose

Quality of Life, Disabilities Multiple

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Health Education
Self Management
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Quality of Life

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of MissouriRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Self Management

Health Education

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change in Katz ADL Index
Disability
Change in PROMIS-29
Health-related quality of life

Secondary Outcome Measures

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

Full Information

First Posted
March 21, 2022
Last Updated
July 27, 2023
Sponsor
University of Missouri-Columbia
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT05379504
Brief Title
Reducing COVID-19 Related Disability in Rural Community-Dwelling Older Adults Using Smart Technology
Official Title
Reducing COVID-19 Related Disability in Rural Community-Dwelling Older Adults Using Smart Technology
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Life, Disabilities Multiple

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Individuals will be randomized to one of two study arms in blocks of 4.
Masking
Outcomes Assessor
Masking Description
Outcomes assessor will be masked to study participant assignment. Baseline assessments will be completed prior to enrollment.
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Self Management
Arm Type
Experimental
Arm Description
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.
Arm Title
Health Education
Arm Type
Active Comparator
Arm Description
Participant's randomized to the standard health education arm will receive the intervention at Month 1 and then months 3, 6, 9 and 12.
Intervention Type
Behavioral
Intervention Name(s)
Standard Health Education
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Self Management
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Katz ADL Index
Description
Disability
Time Frame
1 year
Title
Change in PROMIS-29
Description
Health-related quality of life
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Change in Hospital Anxiety and Depression Scale
Description
Depression and anxiety
Time Frame
1 year
Title
Change in Canadian Occupational Performance Measure
Description
Occupational performance
Time Frame
1 year
Title
Change in Patient Activation Measure
Description
Patient activation/self-efficacy
Time Frame
1 year
Title
Technology Experience Profile
Description
Experience with technology
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel M Proffitt, OTD
Phone
(573) 884-2418
Email
proffittrm@health.missouri.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel M Proffitt, OTD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Proffitt, OTD
Phone
573-884-2418
Email
proffittrm@health.missouri.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We will share de-identified clinical outcome data and parameters extracted from the sensor system (e.gs., motion density, gait speed) associated with the study participants by depositing these data at the National Archive of Computerized Data on Aging (NACDA) which is an NIH-funded repository. Submitted data will confirm with relevant data and terminology standards. Data will be de-identified following the University of Missouri IRB procedures. All sensor parameters are stored on the secure server as de-identified data so no further processing will be required before depositing at NACDA. Identifiers will be removed from clinical outcome data before depositing at NACDA. All personal and private information of study participants will be protected using our secure data collection system (RedCap) on an encrypted network. No personal or private information will be shared.
IPD Sharing Time Frame
Data will be available at the completion of the study and will be held according to parameters for the National Archive of Computerized Data on Aging (NACDA)
IPD Sharing Access Criteria
As I will be using National Archive of Computerized Data on Aging (NACDA), which is an NIH-funded repository, this repository has policies and procedures in place that will provide data access to qualified researchers, fully consistent with NIH data sharing policies and applicable laws and regulations.
IPD Sharing URL
http://www.icpsr.umich.edu/web/pages/NACDA/index.html
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Reducing COVID-19 Related Disability in Rural Community-Dwelling Older Adults Using Smart Technology

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