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

NCT05379504 | Completed

• 2 other identifiers: 20435421R01AG072935-01A1
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life; Disabilities Multiple

Outcome Measures

Primary Outcomes (2)

• Change in Katz ADL Index

  Disability

  1 year

• Change in PROMIS-29

  Health-related quality of life

  1 year

Secondary Outcomes (4)

• Change in Hospital Anxiety and Depression Scale

  1 year

• Change in Canadian Occupational Performance Measure

  1 year

• Change in Patient Activation Measure

  1 year

• Technology Experience Profile

  Baseline

Study Arms (2)

Self Management

EXPERIMENTAL

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

Health Education

ACTIVE COMPARATOR

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

Interventions

Standard Health Education BEHAVIORAL

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.

Health Education

Self Management BEHAVIORAL

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.

Self Management

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Missouri

Columbia, Missouri, 65211, United States

Location

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• Reeder B, Turner AM. Scenario-based design: a method for connecting information system design with public health operations and emergency management. J Biomed Inform. 2011 Dec;44(6):978-88. doi: 10.1016/j.jbi.2011.07.004. Epub 2011 Jul 23.

  PMID: 21807120 BACKGROUND

• Reeder B, Zaslavksy O, Wilamowska KM, Demiris G, Thompson HJ. Modeling the oldest old: personas to design technology-based solutions for older adults. AMIA Annu Symp Proc. 2011;2011:1166-75. Epub 2011 Oct 22.

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• Reeder B, Hills RA, Turner AM, Demiris G. Participatory design of an integrated information system design to support public health nurses and nurse managers. Public Health Nurs. 2014 Mar-Apr;31(2):183-92. doi: 10.1111/phn.12081. Epub 2013 Sep 30.

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• Reeder B, Demiris G. Building the PHARAOH framework using scenario-based design: a set of pandemic decision-making scenarios for continuity of operations in a large municipal public health agency. J Med Syst. 2010 Aug;34(4):735-9. doi: 10.1007/s10916-009-9288-3. Epub 2009 Apr 23.

  PMID: 20703929 BACKGROUND

MeSH Terms

Interventions

Self-Management

Intervention Hierarchy (Ancestors)

Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Rachel M Proffitt, OTD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor will be masked to study participant assignment. Baseline assessments will be completed prior to enrollment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: May 18, 2022
• Study Start: June 1, 2022
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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)
• 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.

Locations

US (1)