NCT03887572

Brief Summary

This observational study is designed to adapt, create actionable implementation, and to access market demand of the Mobilizing Older adults Via a systems-based Intervention (MOVIN) toolkit. MOVIN is a program to increase ambulation while hospitalized at non-academic facilities. MOVIN is a unit-based intervention. Therefore all patients on this unit are exposed to the intervention once it is implemented regardless of whether or not they participate in the trial. The study will enroll 40 total hospitalized participants 65 years and older for the duration of their stay.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 4, 2019

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 25, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2020

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

11 months

First QC Date

March 14, 2019

Last Update Submit

April 18, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change in gait speed

    A 4 meter walk test will be conducted on admission to the study, discharge from the hospital and at 3 months post discharge in the subjects home or the hospital or clinic. A trained member of the research team will conduct the gait speed test. Interrater reliability for the 4 meter walk test will be conducted between all members of the research team prior to collecting gait speed data on study participants. Gait Speed is a physical performance measure identified as a sensitive clinical indicator of health, mortality, healthcare utilization, and independence in ambulation, and is feasible to test in hospitalized older adults. Change scores will be calculated as the difference between gait speeds measured at each of these time points.

    Hospital admission, hospital discharge, 3 months post-discharge; Up to 4 months total

  • Change in Self-report on Katz Activity of Daily Living (ADL) Index

    A trained member of the research team will collect patients self-report of ADLs on admission to the study, discharge from the hospital, by phone at 1 month post intervention, and in person at the 3 month post intervention visit. The Katz ADL Index is a self-report scale that measures five ADL on three levels (independent, requiring assistance of another and unable to do). The scale demonstrates excellent reliability and predictive validity, and is sensitive to change in hospital settings. Change scores will be calculated as the difference between gait speeds measured at each of these time points.

    Hospital admission, hospital discharge, 1 month post-discharge, 3 months post-discharge; Up to 4 months total

  • Change in Life Space Assessment

    A trained member of the research team will collect patients self-report on Life Space at admission to the study, discharge from the hospital, by phone at 1 month post intervention, and in person at the 3 month post intervention visit. The UAB Life Space Assessment: is a self-report scale of ambulation that measures spaces patients' move in, the frequency of moving into those spaces, and dependency in moving into those spaces. This scale has demonstrated reliability and predictive validity and sensitivity to change after hospital stay. Change scores will be calculated as the difference between gait speeds measured at each of these time points.

    Hospital admission, hospital discharge, 1 month post-discharge, 3 months post-discharge; Up to 4 months total

Secondary Outcomes (16)

  • Patient Experience with Ambulation

    1 month post-discharge; Up to 2 months total

  • Age

    Within 3 months post-discharge; Up to 4 months total

  • Gender

    Within 3 months post-discharge; Up to 4 months total

  • Race

    Within 3 months post-discharge; Up to 4 months total

  • Ethnicity

    Within 3 months post-discharge; Up to 4 months total

  • +11 more secondary outcomes

Study Arms (2)

Pre-intervention/control

20 older adult patients (age 65 or older) will be recruited over 3 months prior to implementation of the unit-based MOVIN intervention.

Post-intervention

20 older adult patients (age 65 or older) will be recruited over 3 months after MOVIN has been implemented on the unit for a period of 12-14 weeks.

Other: MOVIN

Interventions

MOVINOTHER

MOVIN is a multi-component unit-based intervention comprised of five components that are implemented simultaneously in a hospital unit. The five components are: 1) psychomotor skills training, 2) unit ambulation culture, 3) communication, 4) resources, 5) ambulation environment.

Post-intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients admitted to the study intervention unit will be recruited to evaluate the implementation of MOVIN based on Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM framework). Patients (N=40) will be recruited during pre (n=20) and post (n=20)-intervention periods to provide an evaluation of effectiveness. Inclusion criteria for patients will consist of age 65 years or older, able to walk with or without assistance, have an ambulation order, and able to speak and understand English.

You may qualify if:

  • age 65 years or older
  • able to walk with or without assistance
  • absence of a medical order for bedrest or activity restriction
  • have an ambulation order
  • able to speak and understand English.

You may not qualify if:

  • activated Power of Attorney
  • a score of 11+ on Orientation Memory Cognition Test (OMCT)
  • a score \<2 on a Mini Cog
  • lower extremity amputation
  • terminal diagnosis (Comfort Care)
  • on hospice
  • bed rest order
  • wheelchair bound

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

Iatrogenic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Linsey M Steege, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2019

First Posted

March 25, 2019

Study Start

March 4, 2019

Primary Completion

February 4, 2020

Study Completion

February 4, 2020

Last Updated

April 19, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations