Impact of a Mobility Program

Hospitalization Clinical Trial

Official title:

Impact of a Hospital Mobility Program on Function After Discharge

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02674503
• Other study ID #: E1995-R
• Status: Completed
• Phase: N/A
• Start date: December 12, 2016
• Est. completion date: September 30, 2021

Study information

• Verified date: March 2022
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hospitalization

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Birmingham VA Medical Center, Birmingham, AL	Birmingham	Alabama
United States	UAB Hospital	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Life-Space Assessment score	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.	One year
Secondary	Presence of adverse outcomes: rehospitalization	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.	One Year
Secondary	Presence of adverse outcomes: nursing home placement	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.	One year
Secondary	Presence of adverse outcomes: death	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.	One year
Secondary	Presence of adverse outcomes (ED visits, rehospitalization, nursing home placement, death).	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.	One year
Secondary	Activities of Daily Living (ADLs)	, cognitive function, level of in-hospital mobility, age, comorbidities, length of stay, depressive symptoms, and social support Patients will be asked to complete the Katz ADL at all interviews during the study. 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).	One Year
Secondary	Instrumental Activities of Daily Living (IADLs)	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 0 to 8, with higher scores indicating higher levels of independence with the tasks.	One year
Secondary	Mini Cognitive Assessment (Mini-Cog)	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.	Baseline only
Secondary	Confusion Assessment Method	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%.	Baseline only
Secondary	Patient Health Questionaire (PHQ) -2	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.	One year
Secondary	EuroQOL five dimensions questionnaire (EQ-5D)	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.	One year
Secondary	Lubben Social Network Scale (LSNS-Revised)	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.	One year
Secondary	Level of Hospital Mobility	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.	Average one week