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Quality of LifeNCT05379504

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

A study testing Standard Health Education and Self Management in people with Quality of Life and Disabilities Multiple, run by University of Missouri-Columbia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Quality of Life, Disabilities Multiple
What is being tested?
Standard Health Education and Self Management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteUnited States
Study dates
1 Jun 2022to 31 Oct 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Missouri

    Columbia, Missouri, 65211

Other trials in United States

About this study

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.

Read the 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. The investigators 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, the investigators 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, the investigators will 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, the investigators 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, the investigators 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.

Being tested
Standard Health Education, Self Management

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard Health EducationBehavioural

    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.

  • Self ManagementBehavioural

    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.

Study groups in NCT05379504
Study groupRoleWhat they receive
Self ManagementExperimentalThe 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.
Receives: Behavioral: Self Management
Health EducationActive comparatorParticipant's randomized to the standard health education arm will receive the intervention at Month 1 and then months 3, 6, 9 and 12.
Receives: Behavioral: Standard Health Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Katz ADL Index

    The Katz Index of Independence in Activities of Daily Living, commonly referred to as the Katz ADL, assesses functional status as a measurement of the client's ability to perform activities of daily living independently. The Index ranks adequacy of performance in the six functions of bathing, dressing, toileting, transferring, continence, and feeding. Clients are scored yes/no for independence in each of the six functions. A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment. This scale ranges from 0 to 6. This measure is the calculated change in score from baseline to post-intervention.

    Measured: 1 year

  2. Change in PROMIS-43

    PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The PROMIS-43 is a collection of 6-item short forms assessing anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, and ability to participate in social roles and activities as well as a single pain intensity item. Each short form is scored as a T-score, with a score of 50 being average. This scale is 0 to 100. Higher scores indicate more (anxiety, depression, etc) and lower scores indicate less.

    This measure is the change in the T-score from baseline to post-intervention. A positive change in T-score is different for each sub-domain. Each will be indicated below in the row title.

    Measured: 1 year

Secondary outcomes (3)

  1. Change in Hospital Anxiety and Depression Scale

    The Hospital Anxiety and Depression Scale is a two dimension scale developed to identify depression and anxiety. There are 14 items. The respondent rates each item on a 4 point scale ranging from 0 (absence) to 3 (extreme presence). Some questions are inversely scored. This outcome was assessed at baseline and post-intervention. This measure is the change in score on the scale. The overall range of scores is 0 to 42. Anxiety and depression domains are reported separately below.

    Measured: 1 year

  2. Change in Canadian Occupational Performance Measure

    The COPM is administered by an occupational therapy practitioner. The participant ranks their five most important occupations that they currently have difficulty with. Then they rate their current performance and satisfaction with that performance on a scale of 1-10. The score on those five occupations are averaged to get a score of self-rated occupational performance and self-rated satisfaction with performance. The scores on both scales can range from 0 to 10. This measure is the change from baseline to post-intervention on both scores, reported separately below.

    Measured: 1 year

  3. Change in Patient Activation Measure

    The Patient Activation Measure® is a 13-item survey that assesses an individual's knowledge, skills and confidence integral to managing one's own health and healthcare. The participants rates how much they agree or disagree (1-4 scale) with 13 statements. Using a licensed tool, a score ranging 0-100 is calculated. This measure is the change in that score from baseline to post-intervention. A positive change score means improvement.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2022
  2. Study start1 Jun 2022
  3. Primary completion31 Oct 2024
  4. Study completion31 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Individuals will be randomized to one of two study arms in blocks of 4.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05379504
Sponsor's protocol ID
2043542
Other IDs
1R01AG072935-01A1
Status last verified
Jul 2026
First submitted
21 Mar 2022
Last updated
24 Jul 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The investigators 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.

Publications

  • Missouri Department of Health and Senior Services 2019. Health in rural Missouri: Biennial report 2018-2019. http://health.mo.gov/living/families/ruralhealth/pdf/biennial2019.pdf

  • Research and Training Center on Disability in Rural Communities. 2020. Missouri State Profile. http://rtc.ruralinstitute.umt.edu/state-profile-map-series/missouri-state-profile/

  • Kane, R, L, (1999). A new model of chronic care. Generations-Journal of the American Society on Aging, 23(2), 35-37

  • Rantz M, Phillips LJ, Galambos C, Lane K, Alexander GL, Despins L, Koopman RJ, Skubic M, Hicks L, Miller S, Craver A, Harris BH, Deroche CB. Randomized Trial of Intelligent Sensor System for Early Illness Alerts in Senior Housing. J Am Med Dir Assoc. 2017 Oct 1;18(10):860-870. doi: 10.1016/j.jamda.2017.05.012. Epub 2017 Jul 12.

    PubMed 28711423

  • Rantz MJ, Scott SD, Miller SJ, Skubic M, Phillips L, Alexander G, Koopman RJ, Musterman K, Back J. Evaluation of health alerts from an early illness warning system in independent living. Comput Inform Nurs. 2013 Jun;31(6):274-80. doi: 10.1097/NXN.0b013e318296298f.

    PubMed 23774449

  • Rantz MJ, Skubic M, Miller SJ, Galambos C, Alexander G, Keller J, Popescu M. Sensor technology to support Aging in Place. J Am Med Dir Assoc. 2013 Jun;14(6):386-91. doi: 10.1016/j.jamda.2013.02.018. Epub 2013 Apr 3.

    PubMed 23562281

  • Skubic M, Guevara RD, Rantz M. Automated Health Alerts Using In-Home Sensor Data for Embedded Health Assessment. IEEE J Transl Eng Health Med. 2015 Apr 10;3:2700111. doi: 10.1109/JTEHM.2015.2421499. eCollection 2015.

    PubMed 27170900

  • Skubic, M., Guevara, R. D., & Rantz, M. (2012). Testing classifiers for embedded health assessment. Proc., International Conference on Smart Homes and Health Telematics, Artimino, Italy, pp. 198-205

  • Jain, A., Keller, J., & Popescu, M. (2019, June 23-26). Explainable Al for dataset comparison, {Paper presentation}. 2019 IEEE International Conference on Fuzzy Systems (FUZZ-IEEE).

  • Ibrahim, O. A., Keller, J., & Popescu, M. (2019) An unsupervised framework for detecting early signs of illness in eldercare. [Paper presentation}. 2019 IEEE International Conference on Bioinformatics and Biomedicine (BIBM), San Diego, CA, USA

  • Ibrahim, O.A., Keller, J.M., & Popescu, M. (2017). Context preserving representation of daily activities in elder care. {Paper presentation}. IEEE International Conference on Bioinformatics and Biomedicine (BIBM)

  • Ibrahim, O.A., Popescu, M., & Keller, J.M. (2017). Unsupervised Analysis of Activity Patterns in Eldercare Monitoring. {Paper presentation}. American Medical Informatics Association (AMIA) Annual Symposium.

  • Wu, W., Keller, J.M., Skubic, M., Popescu, M., & Lane, K.R. (in review). Early detection of health changes in the elderly using in-home multi-sensors data streams.

  • Mishra, A.K., Skubic, M., Despins, L.A., Popescu, M., Rantz, M., Keller, J., & Lane, K. (2019). Development of a functional health index for older adults using the electronic health record. {Paper presentation}. IEEE EMBS International Conference on Biomedical & Health Informatics (BHI), Chicago, IL, United States.

  • Robinson EL, Park G, Lane K, Skubic M, Rantz M. Technology for Healthy Independent Living: Creating a Tailored In-Home Sensor System for Older Adults and Family Caregivers. J Gerontol Nurs. 2020 Jul 1;46(7):35-40. doi: 10.3928/00989134-20200605-06.

    PubMed 32597999

Questions about this trial

What is this clinical trial studying?

A study testing Standard Health Education and Self Management in people with Quality of Life and Disabilities Multiple, run by University of Missouri-Columbia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Katz ADL Index (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05379504, which also lists 95 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.

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