Clinical trial NCT02674503: Impact of a Mobility Program
Official title: Impact of a Hospital Mobility Program on Function After Discharge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hospitalization
Keywords: Walking
Hospitalization
Randomized controlled trial
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-02-04
Enrollment: 132
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
  * Additional exclusion criteria will include:
  * 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

Primary outcomes:
measure: Life-Space Assessment Score
timeFrame: One year
Secondary outcomes:
measure: Presence of Adverse Outcomes: Rehospitalization
timeFrame: One Year
measure: Presence of Adverse Outcomes: Nursing Home Placement
timeFrame: One year
measure: Presence of Adverse Outcomes: Death
timeFrame: One year
measure: Activities of Daily Living (ADLs)
timeFrame: One Year
measure: Presence of Adverse Outcomes (ED Visits, Rehospitalization, Nursing Home Placement, Death)
timeFrame: One year
measure: Instrumental Activities of Daily Living (IADLs)
timeFrame: One year
measure: Mini Cognitive Assessment (Mini-Cog)
timeFrame: Baseline only
measure: Confusion Assessment Method
timeFrame: Baseline only
measure: Patient Health Questionnaire (PHQ) -2
timeFrame: One year
measure: EuroQOL Five Dimensions Questionnaire (EQ-5D)
timeFrame: One year
measure: Lubben Social Network Scale (LSNS-Revised)
timeFrame: One year
measure: Level of Hospital Mobility
timeFrame: Average one week
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham VA Medical Center, Birmingham, AL
state: Alabama
city: Birmingham
country: United States
facility: UAB Hospital
state: Alabama
Study officials:
affiliation: Birmingham VA Medical Center, Birmingham, AL
name: Cynthia J Brown, MD MSPH
role: PRINCIPAL_INVESTIGATOR
References: