Impact of a Mobility Program

NCT ID: NCT02674503

Last Updated: 2024-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-12
• Study Completion Date: 2021-09-30

Brief Summary

After hospitalization, many older adults experience more difficulty getting around in the community and performing one or more of their basic activities of daily living (ADLs) like bathing or dressing. The goals of this study are to test the effectiveness of a mobility intervention, compared to usual care, on change in mobility after hospitalization, to determine the impact on one-year outcomes such as nursing home placement and to identify which Veterans benefit the most from the intervention. Ultimately, the goal is to improve recovery after hospitalization and reduce disability in hospitalized Veterans.

Detailed Description

For this high impact study the investigators propose to use a stepped wedge cluster randomization design on five VA hospital wards to compare a mobility program (MP) to usual care (UC) among a cohort of Veterans age 50 years. The investigators will examine pre to post-hospital mobility and adverse outcomes including functional decline, nursing home admission, emergency department (ED) visits, hospitalization and death in the MP and UC groups in the year after hospital discharge. The primary outcome of mobility will be measured by the University of Alabama at Birmingham (UAB) Life-Space Assessment (LSA).10-13 Secondary measures of mobility will include self-reported ability to walk mile and drive a car, as described by Gill, et al.14 The investigators will identify patient specific characteristics that modify the effect of the mobility intervention on post-hospital mobility and adverse outcomes to determine which hospitalized patients are most likely to benefit from this intervention.

Note, Secondary outcome measures were curtailed as the original PI, Dr. Brown, retired.

Conditions

Hospitalization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intensive

MP patients will participate in a program of progressive walking and transfer training up to three times a day, seven days a week throughout the hospital stay.

Group Type: EXPERIMENTAL

Walking

Intervention Type: BEHAVIORAL

MP patients will participate in a program of progressive walking and transfer training up to three times a day, seven days a week throughout the hospital stay. MP patients will begin with assisted sitting, then standing, progressing to weight shifting and stepping in place, and then to walking as tolerated. The level of mobility recommended to the MP patient by the Walker will be dependent on the individual patient and will incorporate the activities patients were deemed able to do independent of cueing or assistance during each walking session.

Friendly visit

UC patients will receive three times a day "friendly visits", seven days a week by members of the research team to control for the daily attention that MP patients receive.

Group Type: PLACEBO_COMPARATOR

Friendly visit

Intervention Type: BEHAVIORAL

UC patients will receive three times a day "friendly visits", seven days a week by members of the research team to control for the daily attention that MP patients receive.

Interventions

Walking

MP patients will participate in a program of progressive walking and transfer training up to three times a day, seven days a week throughout the hospital stay. MP patients will begin with assisted sitting, then standing, progressing to weight shifting and stepping in place, and then to walking as tolerated. The level of mobility recommended to the MP patient by the Walker will be dependent on the individual patient and will incorporate the activities patients were deemed able to do independent of cueing or assistance during each walking session.

Intervention Type: BEHAVIORAL

Friendly visit

UC patients will receive three times a day "friendly visits", seven days a week by members of the research team to control for the daily attention that MP patients receive.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age 50 years admitted to one of the five hospital wards of the Birmingham VA Medical Center (VAMC) for any medical illness, e.g.:

• Pneumonia
• Heart failure
• Chronic obstructive pulmonary disease (COPD) exacerbation
• Or other medical (versus surgical) indication for hospitalization
• Patients will be recruited within 48 hours of hospitalization, followed throughout their hospitalization and for one year after hospital discharge.

Exclusion Criteria

• Patients admitted for brief observation will be excluded, e.g.:

• 23-hour observation for possible myocardial infarction
• Inability to walk across a small room 2 weeks prior to admission
• Inability to walk safely with assistance, based on a strength and balance screen (see Training of Walkers, below for details)
• Having a pulmonary embolus, unstable angina or other medical diagnosis deemed by the primary physician to be a contraindication to walking
• Being on hospice or comfort care
• Being in a semi-private room with another currently enrolled participant
• Non-English speaking, blind, or deaf

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cynthia J Brown, MD MSPH

Role: PRINCIPAL_INVESTIGATOR

Birmingham VA Medical Center, Birmingham, AL

Locations

Birmingham VA Medical Center, Birmingham, AL

Birmingham, Alabama, United States

UAB Hospital

Birmingham, Alabama, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

E1995-R

Identifier Type: -

Identifier Source: org_study_id