Impact of a Mobility Program

Not Applicable

Completed

• Conditions: Hospitalization
• Interventions: Behavioral: Friendly visit; Behavioral: Walking

• Registration Number: NCT02674503
• Lead Sponsor: VA Office of Research and Development

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.

Study Timeline

• Study First Submitted: 2016-01-08
• Study First Submitted QC: 2016-02-03
• Study First Posted: 2016-02-04
• Study Start: 2016-12-12
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Results First Submitted: 2023-02-15
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-26
• Last Update Submitted: 2024-03-26
• Results First Posted: 2024-07-05
• Last Update Posted: 2024-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Friendly visit	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.
Intensive	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.

Primary Outcome Measures

Name	Time	Method
Life-Space Assessment Score	One year	The UAB Study of Aging Life-Space Assessment (LSA) is a validated tool that measures mobility and function based on the distance which a person reports moving during the four weeks preceding the assessment. The range in scores is 0-100 with higher scores representing better life space mobility.

Secondary Outcome Measures

Name	Time	Method
Presence of Adverse Outcomes: Rehospitalization	One Year	To determine the impact of participation in the mobility program on adverse outcomes, the investigators will measure the frequency of rehospitalization in the MP versus UC groups.
Presence of Adverse Outcomes: Nursing Home Placement	One year	To determine the impact of participation in the mobility program on adverse outcomes, the investigators will measure the frequency of nursing home placement in the MP versus UC groups.
Instrumental Activities of Daily Living (IADLs)	One year	Level of independence with Instrumental Activities of Daily Living (IADLs) will be assessed at the same time points as the basic ADLs using the Lawton Index. The IADL index evaluates 8 domains of function including shopping, food preparation, housekeeping, laundry, transportation, handling finances, ability to take own medications and use of the telephone. A summary score ranges from 3 to 24, with higher scores indicating higher levels of independence with the tasks. Score options were trichotomous (1 = unable, 2 = needs assistance, 3 = independent).
Activities of Daily Living (ADLs)	One Year	Participants will be asked to complete the Katz ADL. Specifically, patients will be asked to rate their current level of independence with six activities of daily living (feeding, bathing, dressing, toileting, transferring, and walking across a small room). Scores range from 0-12, with lower scores representing better independence in activities of daily living.
Presence of Adverse Outcomes: Death	One year	To determine the impact of participation in the mobility program on adverse outcomes, the investigators will measure the frequency of death in the MP versus UC groups.
Confusion Assessment Method	Baseline only	The Confusion Assessment Method (CAM) allows rapid assessment of the presence of delirium. Four clinical features, including 1) Acute onset and fluctuating course; 2) Inattention; 3) Disorganized thinking; and 4) Altered level of consciousness, are assessed. The presence of features 1 and 2 and either 3 or 4 indicates the patient has delirium. The positive and negative predictive values for the CAM are approximately 90%.
Patient Health Questionnaire (PHQ) -2	One year	Patients will be asked at each interview the Patient Health Questionnaire (PHQ) - 2, specifically 1) Have you often been bothered by feeling down, depressed, or hopeless?; and 2) Have you often been bothered by little interest or pleasure in doing things? The PHQ-2 has been found to have a sensitivity and specificity of 83% and 92% respectively and is an excellent brief screening tool for depression.
Presence of Adverse Outcomes (ED Visits, Rehospitalization, Nursing Home Placement, Death)	One year	To determine the impact of participation in the mobility program on adverse outcomes, the investigators will measure the frequency of ED visits, hospitalizations as well as death and nursing home admissions including both short and long term placement in the MP versus UC groups.
Mini Cognitive Assessment (Mini-Cog)	Baseline only	The Mini-Cog is a brief cognitive screening measure that includes a three-item memory recall and a clock drawing test. The test is scored using a simple algorithm whereby patients who are unable to recall any of the three items are considered demented; those who can recall all three items are deemed not demented; and those with intermediate word recall ability (1 or 2 items) are classified based on the clock drawing test. For persons with intermediate recall ability, if the clock drawing is abnormal, the patient is considered demented and if the clock drawing is normal the patient is not considered demented.
EuroQOL Five Dimensions Questionnaire (EQ-5D)	One year	Patients will be asked to complete the EQ-5D once during the hospital stay, then at months 1, 3, 6, 9, and 12. The EQ-5D-3L is a well-validated measure of quality of life which enables the calculation of a single index value ranging from 0, worst imaginable health to 1, perfect health.
Lubben Social Network Scale (LSNS-Revised)	One year	The Lubben Social Network Scale (LSNS) was designed to measure perceived social support received from family and friends. The LSNS-Revised includes 12 items with scores ranging from 0-60 with higher scores indicating greater perceived social support.
Level of Hospital Mobility	Average one week	All patients will wear a StepWatch throughout the hospitalization to document the level of mobility attained by each patient. The StepWatch is a ankle worn pedometer that documents number of steps taken and when they were taken.

Trial Locations

Locations (2)

Birmingham VA Medical Center, Birmingham, AL; 🇺🇸 Birmingham, Alabama, United States

UAB Hospital; 🇺🇸 Birmingham, Alabama, United States