Impact of a Hospital Mobility Program on Function After Discharge
Phase: NA
Conditions: Hospitalization
Sponsor: VA Office of Research and Development

2021.02.05 Protocol page 1 
DETAILED RESEARCH PROTOCOL 
February 5, 2021 
A. PURPOSE: State briefly the purpose of the study; usually this will include the hypothesis, which is to be
tested.
Many older adults experience increased difficulty moving about their communities and performing one or 
more of their basic activities of daily living (ADLs) after undergoing a hospitalization. The purposes of this study 
are (1) to test the effectiveness of a mobility intervention, compared to usual care, on change in mobility after 
hospitalization; (2) to determine the impact on one-year outcomes (such as nursing home placement); and (3) to 
identify which patients benefit the most from the intervention. Ultimately, our goal is to improve recovery after 
hospitalization and reduce disability in hospitalized patients. 
B. BACKGROUND: Describe past studies and, if relevant, experimental or clinical findings which led to the
plan for this project. This must be succinct and comprehensible without extensive reference to other
material. A few pertinent references may be cited. In some cases -- e.g., as in cases where earlier studies have
produced conflicting evidence -- it will be necessary to cite these studies and explain how it was decided to
rely on one side or the other. For studies designed to compare or evaluate therapies, there should be a
statement of the relative advantages or disadvantages of alternative modes of therapy. This section should
ordinarily be less than one page long; however, when necessary it may be longer.
Low mobility, defined as mobility limited to bed rest or bed to chair transfers, is common during 
hospitalization.1 Our prior work has shown that hospitalized older adults spend greater than 80% of their hospital 
stay lying in bed and less than 43 minutes per day walking, despite being cognitively intact and able to walk on 
hospital admission.2 Low mobility is associated with adverse outcomes including functional decline, nursing 
home placement, and death, even after controlling for illness severity and comorbidity.1 Functional disability after 
hospitalization is common, and up to one-third of those who experience a decline do not recover.1,3 Mobility is a 
key component of functional disability. Decreases in functional ability are not restricted to older adults; patients 
in their 5th decade have been shown to experience declines in strength, pulmonary function and submaximal 
exercise tolerance after five days of hospitalization.4 Intervention studies examining the effect of encouraging 
mobility during hospitalization are sparse and typically measure outcomes in hospital or in the 30 days after 
discharge.5-7 While data on the long-term impact of a hospital mobility program is lacking, evidence from 
observational studies reveals that higher levels of hospital mobility are associated with reduced nursing home use 
and mortality.7,8 In our recent VA-funded pilot randomized controlled trial (RCT), we showed that cognitively 
intact older veterans who received a mobility intervention had higher community mobility, measured with the 
UAB Life-Space Assessment (LSA), one month after hospital discharge compared with the usual care group.9 
However, this preliminary work was restricted to one month of follow-up of veterans who were cognitively intact 
and ≥ 65 years of age. A number of important gaps remain in our understanding of the impact of a hospital 
mobility program: 1) hospital mobility program studies have not used a randomized controlled trial (RCT) design 
to evaluate the impact; 2) the actual number of steps and time spent walking by participants has not been 
measured; 3) outcomes beyond 30 days’ post-discharge have not been examined; and 4) characteristics of patients 
most likely to benefit from this type of intervention have not been identified. 
For this high-impact study, we propose to use a stepped wedge cluster randomization design on five VA 
hospital wards and at UAB Hospital on four hospital wards to compare a mobility program (MP) to usual care 
(UC) among a cohort of veterans and other patients age ≥ 50 years. We 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 mobility program (MP) and usual care (UC) groups in the year after hospital 
discharge. The primary outcome of mobility will be measured by the UAB Life-Space Assessment (LSA).10-13 
Secondary measures of mobility will include self-reported ability to walk ¼ mile and drive a car, as described by 
Gill, et al.14 We 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. 
Impact of a Hospital Mobility Program on Function after Discharge
NCT02674503

2021.02.05 Protocol page 2 
 
C. SPECIFIC LOCATION OF STUDY: Where will the research take place? (When other institutions are 
involved it may be necessary to secure the approval of their Institutional Review Boards.) 
 
Patients admitted to the medical wards of the BVAMC (4A, 4B, 5A, 5B, and 6B) and to medical wards at 
UAB Hospital (3 Hospitalist Units, and the Tinsley Harrison service) will be eligible to participate in this study. 
A brief screening interview will be conducted with the ward team to identify patients who meet eligibility criteria; 
if eligible, consent to interview the patient will be requested from the physician. Interviews to further determine 
eligibility and to obtain consent will be conducted in patient rooms. While a participant is hospitalized, study 
assessments, tests, and interventions will be conducted in patient rooms or, for walking sessions and gait speed 
assessments, in the hallways of the BVAMC or UAB Hospital. Post-discharge assessments will occur over 
telephone or, in the rare event that a patient has been re-hospitalized at BVAMC or UAB Hospital, in the 
participant’s hospital room. Telephone assessments will be conducted from rooms 8211, 8223, 8224 and 8218 in 
the BVAMC. Study staff will conduct these assessments from these private offices with the door closed. 
Hard copy study records for recruited Birmingham VAMC veterans will be secured in locked file cabinets 
within locked offices in rooms 8211, 8223, 8224 and 8218 in the BVAMC, with access and key distribution 
limited to authorized staff. Electronic records will be stored on a VA secure server; only authorized project staff 
members will have access to the data and the drives/directories on which they are stored. No PHI will be 
removed from the VA protected environment, nor will any PHI be transmitted electronically. De-identified data 
sets (data excluding HIPAA identifiers) may be emailed to study statisticians approved by the VA IRB to their 
UAB email accounts. De-identified data will be stored on secure servers maintained by UAB and accessible 
solely to study staff on a need-to-know basis. Data sets will be reviewed by the BVAMC Privacy Officer or 
their representative and will approve all data transfers to UAB. Statisticians will return all analyses to the study 
PI at BVAMC, and VA data will be deleted from the UAB server when analyses are complete. 
 
Patients admitted to UAB Hospital will also be eligible to participate in this study. Screening and 
identification of eligible patients will follow the same procedures as at the BVAMC. UAB participants’ 
assessments will occur at UAB; hard copy and electronic records of UAB patients will be stored within UAB 
facilities as approved by the UAB IRB. 
 
D. PROBABLE DURATION OF PROJECT: This should be the estimate for the entire study. (IRB 
reapproval is required at least every year as long as the study is continued. In specific cases, more frequent 
reapproval may be required.) 
 
Active recruitment of participants is expected to last 36 months; all participant assessments are anticipated 
to be completed in 48 months. Data interpretation and manuscript preparation are anticipated to take two years, 
for a total estimated study duration of six years. 
 
E. RESEARCH PLAN: This is an orderly description of the intended procedures as they directly affect the 
subjects. There need not be a detailed account of techniques that do not affect the human subject. Include 
length of time for various procedures and frequency of repetition, any manipulation that may cause 
discomfort or inconvenience, and plans for follow-up. If questionnaires or non-standard rating scales are to 
be used, include copies. (If the rating scale is a standard and familiar one, it is only necessary to name it and 
no copy need be submitted.) 
 
Statistical considerations: Studies which cannot be expected to answer the questions posed by the research, 
because of small numbers, low statistical power or other major flaws in research design, can provide no 
benefit to the subject and cannot justify even the smallest degree of subject inconvenience, let alone risk. 
Therefore, except for pilot studies, which are clearly designed to further the development of a more extensive 
research protocol, this section should include a) the number of subjects expected to enter the study, b) a 

2021.02.05 Protocol page 3 
 
statement about the statistical power of the study to test the major hypothesis, and c) a summary of the plans 
for statistical analysis. 
 
Screening, Recruitment & Consent 
258 participants, age ≥ 50 years admitted for any medical illness (e.g. pneumonia, heart failure, COPD 
exacerbation, or other medical (versus surgical) indication for hospitalization) to either one of the five medical 
wards of the Birmingham VAMC, or to one of four units at UAB Hospital, will be recruited within 48 hours of 
hospitalization, and followed throughout their hospitalization and for 12 months after hospital discharge. 
Within 48 hours of admission, patients meeting age and ward criteria for the study will be identified daily (as 
staffing allows) by reviewing the electronic medical record (EMR). Study staff will then contact the medical 
physician team assigned to the patient and will conduct a brief screening interview with the team to assure the 
patient meets inclusion and exclusion criteria.  
After speaking with the medical team, study staff will meet with eligible patients in their hospital rooms to 
briefly inform them about the study and ask if they are interested in hearing more details. If a patient expresses 
interest, the study will be explained and questions answered. Patients will be told they will be visited three times 
a day and have several assessments done. They will be informed they will be assigned to either MP or UC 
depending on their ward assignment. All patients will be informed that they will wear a StepWatch®, which 
counts the steps they take, and that they will be followed with periodic telephone calls for one year after discharge. 
If the patient is still agreeable, the Mini-Cog15,16 and CAM17 will be administered to aid in determining the 
patient’s decision-making capacity.  
If the patient is deemed cognitively intact based on the Mini-Cog and CAM scores, the consent process will 
continue. If the patient consents, a brief physical screen will be administered: Patients will be asked if they were 
able to walk across a small room in the 2 weeks prior to admission, and a progressive functional assessment will 
be administered in which the patient will be asked to sit and then to stand. If the patient successfully completes 
the physical screening, the patient will be randomized. If a patient is deemed to be unsafe based on the functional 
assessment within the 36-hour recruitment window, then a referral to physical therapy will be sought from the 
physician and the patient will not be randomized nor take part in further study activities. 
If the patient scores < 3 on the Mini-Cog or > 0 on the CAM, the consenting individual will consult with the 
patient’s physician. Study staff will inform the physician of the scores, and ask the physician to determine 
whether the patient has decision-making capacity. If the physician indicates that the patient does indeed have 
decision-making capacity, the consent process will continue. If the physician deems that the patient does not 
have decision-making capacity, study staff will ask the physician to enter a EMR note documenting that the 
patient does not have decision-making capacity, if such a note or document does not already exist in the EMR. 
Once such documentation has been created or identified in either the EMR or VISTA, study staff will review 
the EMR and/or Vista to identify the appropriate Legally Authorized Representative (Power of Attorney, Legal 
Guardian, or Next of Kin). Once identified, the LAR will be contacted in person at the bedside or via the 
contact information in the electronic records and informed of the study. If the LAR is contacted on the phone, 
the study will be briefly described and the LAR will be asked if they are interested in hearing more details. If 
the LAR expresses interest, the study will be more fully explained and questions answered. Consenting staff 
will ask if the LAR will be physically present in the BVAMC before the patient has been hospitalized for 48 
hours (see inclusion/exclusion criteria). If so, consenting staff will attempt to meet with the LAR at the bedside 
at a time convenient for the LAR. Consenting staff will meet the LAR and the patient, briefly inform them 
about the study and ask if they are interested in hearing more details. If a patient expresses interest, the study 
will be explained and questions answered. Patients will be told they will be visited three times a day and have 
several assessments done. They will be informed they will be assigned to either MP or UC depending on their 
ward assignment. All patients will be informed that they will wear a StepWatch®, which counts the steps they 
take, and that they will be followed with periodic telephone calls for one year after discharge. If the patient and 
LAR are still agreeable, the consent process can continue. If the patient and LAR consent, a brief physical 
screen will be administered as described above. 

2021.02.05 Protocol page 4 
 
If the LAR is first contacted by visiting the patient’s room, then consenting staff will describe the study 
to the LAR and the patient; if both the LAR and the patient express interest, then the screening process will 
proceed, as described above. 
Identification, contacting, and consenting of potential UAB participants’ LARs will follow UAB procedures 
and guidelines. 

2021.02.05 Protocol page 5 
 
Figure 1. Screening Flowchart (BVAMC)  
 
Stop process 
Attempt to contact LAR via info 
in electronic records.  
Did you reach LAR? 
No 
Yes 
Stop process 
Meet LAR & pt in pt’s room 
Briefly inform LAR of study, invite them to talk more 
about it in pt’s room (before the 48 hr window 
closes). Did s/he agree? 
Yes 
No 
Review Medical 
Teams’ lists in CPRS. 
ID pts ≥50 yrs old. 
Go to the room of the eligible pt.  
Explain study, answer questions, 
administer cognitive screen.  
Is the Mini-Cog and/or CAM 
positive? 
Interview Med Teams. 
Ask about in/exclusion 
criteria for each pt. 
Proceed with screening and consent process: 
Explain study, answer questions. If still 
interested, review consent and HIPAA forms, 
and sign forms (as decided by LAR and pt); 
administer physical screen. 
Proceed with screening and 
consent process: Review consent 
and HIPAA forms, and sign forms 
(as decided by pt); administer 
physical screen. 
Yes 
No 
Inform pt’s physician of 
test results. Does the MD 
say that the patient has 
decision-making 
capacity? 
Yes 
Identify documentation establishing lack of 
decision-making capacity in CPRS, or ask the 
MD to create such documentation. 
When such documentation has been identified/ 
created, review CPRS/VISTA for appropriate 
LAR. 
Is an LAR on record?
Stop process 
Go to pt’s room.  
Is the LAR present?
No 
Yes 
No 

2021.02.05 Protocol page 6 
 
  
In-Hospital Procedures 
Baseline 
Baseline Assessments: After consent, a number of baseline assessments will be administered by study staff using 
standard testing procedures. These assessments may be administered over two or more sessions: One set of 
assessments is to be administered on Day 1 of the study and takes a little more than 20 minutes to complete; the 
second set maybe be completed at any time during hospitalization, and takes about 25 minutes to complete. (See 
Tables 2 and 3). Study staff will be sensitive to the participant’s comfort level, and may postpone or eliminate 
any assessments if the participant expresses fatigue. Staff will also collect demographic information, as well as 
contact information for post-discharge assessments. 
Depression Assessment: Patients will be administered the Patient Health Questionnaire (PHQ) – 2, which 
is a 2-question screening tool for depression.18 Surrogate responses will not be solicited for this assessment. A 
positive answer to either question is considered a positive screen and will lead the interviewer to complete the 
PHQ-9.19 Scores for PHQ-9 range from 0 – 27, with higher scores indicating higher levels of depression. If a 
patient is noted to have a PHQ-9 ≥11, indicating moderate depression, the patient’s BVAMC or UAB physician 
will be notified by study staff.  
 
TABLE 1
Screening Procedures 
Procedure
Length of Time Required of 
Participants 
Frequency of Repetition
EMR review  
0 minutes   (performed by staff) 
Once 
Screening interview with medical team 
0 minutes   (performed by staff) 
Once 
Mini-cog
5 minutes
Once
Confusion Assessment Method (CAM)
<1 minutes
Once
LAR Identification, as necessary
0 minutes   (performed by staff)
Once
Ambulation question
<1 minutes
Once
Progressive functional assessment  
(sit, stand)
5 minutes 
Once 
Total
<12 minutes
TABLE 2
Baseline Assessments, Part 1: to complete on first day in the study 
Procedure
Length of Time Required of 
Participants 
Frequency of Repetition
Condensed Memorial Symptom 
Assessment Scale (CMSAS)
5 minutes 
Once 
Katz ADL
3 minutes
Once
Lawton IADL
3 minutes 
Once
UAB Life-Space Assessment
5 minutes
Once
Gait speed
5 minutes
Once
Step count monitoring (via  StepWatch) 
0 minutes (worn while in hospital) 
Continuous during 
hospitalization
Total
21 minutes
 

2021.02.05 Protocol page 7 
 
 
TABLE 3
Baseline Assessments, Part 2: to complete prior to hospital discharge 
Procedure
Length of Time Required of 
Participants 
Frequency of Repetition
Ability to walk/drive 
1 minute
Once
Fall history (previous 4 weeks)
1 minute
Once
ED visit & hospitalization history  
(previous 6 months)
1-6 minutes 
Once 
PHQ-2 (& PHQ-9, as appropriate) 
         (depression screening tool)
2 – 6 minutes 
Once 
Lubben Social Network Scale
7 minutes
Once
EQ-5D-3L (quality of life index)
5 minutes
Once
Total
17-26  minutes
 
Mobility Monitoring: The StepWatch® mobility monitor by Modus Health is a small (70 
x 50 x 20 mm) waterproof, self-contained accelerometer pedometer that is attached 
loosely to the ankle via a Velcro strap and captures number of steps taken and when the 
steps were taken.20 A StepWatch® pedometer will be applied to the ankle and will be 
worn for the duration of the in-hospital portion of the study by all participants. All patients 
in the study will wear a StepWatch to allow comparisons of mobility achieved by both the 
Mobility Program (MP) and Usual Care (UC) groups. Our team has extensive experience 
with the StepWatches, having used the device in our previous VA Merit study at the 
BVAMC. Flyers with the study’s pager number 
will be placed on or near the whiteboard located 
in all patient rooms, and nursing will be informed 
of the patient’s participation in the study and 
asked to call study staff if there are any questions 
about the pedometers.  The pedometers will be 
removed as needed if they interfere with routine 
care, such as MRIs or other procedures. 
The StepWatch pedometer is 
programmed and downloaded with a standard 
computer via a docking station that plugs into a 
USB port. The device itself provides no 
feedback to the patient and no PHI will be 
stored on the device; the only data recorded is 
the number of steps per minute per day (see 
Figure 3, sample output from StepWatch). As no 
PHI is stored on the device, encryption is not 
necessary. Data cannot be accessed without the 
docking station and software provided by 
Modus Health. We have used this hardware and 
software with no incidents in our previous study 
at BVAMC (IRB Study ID #01332). For our 
new study, an updated version of the software 
will be necessary; the license will be held by the 
VA, and will be paid for by VA Merit grant 
funds. All data will be stored on secure server 
Figure 2: StepWatch
Figure 3: StepWatch data output 

2021.02.05 Protocol page 8 
 
(birresearch), accessible only by authorized study staff. No data will be stored in temporary files or on hard 
drives. 
 
Randomization 
Participants will be assigned to MP or UC using cluster randomization based on hospital ward at both the 
Birmingham VAMC and UAB Hospital. At study initiation, all five wards at the Birmingham VAMC will be 
assigned to the usual care group. Every 5 months a randomly chosen ward will shift from receipt of usual care to 
the mobility program (See Figure 4). At UAB Hospital, all four wards will be assigned to the usual care group at 
study initiation, which is expected to be at month 24 of the study. Every 3 months a randomly chosen study ward 
will shift from receipt of usual care to the mobility program (See Figure 4A). MP patients will receive three daily 
visits for progressive ambulation; the UC group will receive three daily “friendly visits.” Both groups will receive 
routine medical care as it is currently provided, including the provision of physical therapy if ordered by the 
physician.  
 
Figure 4: Stepped Wedge Cluster Randomization with 5 VA Hospital Units. The order in which each unit receives the intervention 
is randomized, with staggered implementation. By conclusion of observation, all units have received the intervention. MP (grey bars) = 
Mobility Program initiated and continued on ward unit. 
         Time
(in months)
Unit 
1/18/17-
6/18/17
6/19/17 – 
11/18/17 
11/19/17 – 
4/18/18
4/19/18 – 
9/18/18
9/19/18 – 
2/18/19
2/19/19 – 
7/18/19
7/19/19 – 
12/31/19
A
Control
MP
B
Control
MP
C
Control
MP
D
Control
MP
E
Control
MP
 
Figure 4A: Stepped Wedge Cluster Randomization with 4 Hospital Units at UAB Hospital. The order in which each unit receives 
the intervention is randomized, with staggered implementation. By conclusion of observation, all units have received the intervention. 
MP (grey bars) = Mobility Program initiated and continued on ward unit. 
         Time
(in months)
Unit 
5/1/18 – 7/31/18 
8/1/18 – 10/31/18 
11/1/18 – 
1/31/19
2/1/29 – 4/30/19 
5/1/19 – 7/31/19 
8/1/19 – 
12/31/19
A
Control
MP
B
Control
MP
C
Control
MP
D
Control
MP
 
Daily visits 
Mobility Program Group (MP):  
MP patients will participate in a program of progressive walking and transfer training up to three times a 
day, seven days a week (as staffing allows) throughout their hospital stays. MP participants 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 participant by study staff will be dependent on the 
individual participant and will incorporate the activities patients were deemed able to do independent of cueing 
or assistance during each walking session. For example, if a participant could stand at the bedside independently, 
but required standby assistance for walking, the participant would be encouraged to sit on the side of the bed for 
meals and stand up beside the bed for 3-5 minutes every two hours as able. To assure participant safety, 
participants will be instructed not to attempt to transfer or walk without nursing assistance if deemed to be 
dependent in these activities. The participant and study staff will set daily goals regarding the amount of time the 
participant will aim to spend out of bed and what level of activity the participant will work on independently. For 
example, a participant may decide that s/he would like to try to walk to the nurse’s station or to the elevators and 
that activity would be attempted with the help of study staff. We anticipate that each session will take 15 - 20 

2021.02.05 Protocol page 9 
 
minutes; the overarching goal is to progress the participant toward walking as tolerated. A rolling walker or 
rollator will be provided for walking as needed. This ambulatory device may be left in the room if participants 
wish, and if they demonstrate that they are able to use the device safely and independently.  
During each walk, participants will be asked to rate their exertion using the Perceived Exertion Index 
(PEI), a simple rating scale ranging from 1 (not tired at all) to 10 (maximal fatigue), in order to take into account 
the effort and fatigue they may experience while walking. They will be encouraged to walk at a pace that is 
comfortable. If they indicate that their PEI is higher than 6, they will be asked to stop and rest.  
While MP participants will be encouraged to walk during each study visit, they may refuse any or all 
sessions. Study staff will attempt to make several visits for each scheduled walk. If a participant is away at a test 
or procedure, or busy with another healthcare provider, staff will return at a later time to walk with the participant.  
 
Usual Care Group (UC): 
UC participants will receive three times a day "friendly visits," seven days a week as staffing allows, to 
control for the daily attention that MP patients receive. The "friendly visits" will be approximately 15 - 20 
minutes in length. Like the MP group, the UC group will wear a StepWatch throughout their hospital stay. 
These data will be used to document the amount of mobility attained by the UC group, but will not be shared 
with UC patients. If a participant is away at a test or procedure, or busy with another healthcare provider, staff 
will return at a later time to visit with the participant. Like MP participants, UC participants may refuse any or 
all visits. 
 
Both MP and UC Groups: 
Additional data collected for both groups will include daily physician mobility orders, as well as physical 
barriers to patient mobility such as IVs, oxygen tubes, etc. Also, as noted earlier, all participants will continue to 
wear the StepWatch, except in the unusual event that it should interfere with care (such as MRIs), or if the 
participant should request its removal. 
A questionnaire, the Acute Care Mobility Assessment (ACMA), has been developed for use at the bedside 
as an assessment of mobility.  In a small pilot study at the Birmingham VAMC, we compared results from wireless 
mobility monitors to patient’s and nurses’ ACMA scores and found a correlation of 0.62 for both patients and 
nurses. We wish to continue our validation of this simple instrument in conjunction with usage of the 
StepWatches. All patients will complete this 5-minute assessment each day they are in the hospital. 
 
TABLE 4
Daily while in Hospital: Mobility Program (MP) Group 
Procedure
Length of Time Required of Participants
Frequency of Repetition
Mobility session  
(walks w/ goal setting & safe ambulation review)
20 minutes 
Up to 3x/day  
Acute Care Mobility Assessment (ACMA)
5 minutes
1x/day
Perceived Exertion Index 
<1 minute 
during walks, up to 
3x/day 
Daily mobility orders & barriers 
0 minutes (performed by staff)
1x/day
Step count monitoring (via StepWatch) 
0 minutes (worn while in hospital) 
Continuous during 
hospitalization
Total
Up to 65 minutes per hospital day
 
 
 
 
 
 
 
 

2021.02.05 Protocol page 10 
 
TABLE 5
Daily while in Hospital: Usual Care (UC) Group 
Procedure
Length of Time Required of Participants
Frequency of Repetition
Friendly visit
15-20  minutes
Up to 3x/day
ACMA
5 minutes
1x/day
Daily mobility orders & barriers
0 minutes (performed by staff)
1x/day
Step count monitoring (via StepWatch) 
0 minutes (worn while in hospital) 
Continuous during 
hospitalization
Total
Up to 65 minutes per hospital day
 
 
Transfer to ICU/CCU or Safe Harbor/Palliative Care Unit 
There is a possibility that a participant may be transferred to ICU or CCU after enrollment but before 
discharge. Should this occur, activities requiring the participant’s active involvement will cease (e.g., friendly 
visits, mobility sessions, questionnaires), but chart reviews will continue. Post-discharge follow-up assessments 
will be administered per protocol after discharge from ICU/CCU.  
There is a very slight possibility that a participant may be transferred to Safe Harbor or the Palliative 
Care Unit after enrollment but before discharge. Should this occur, the participant will be offered the 
opportunity to withdraw from the study, or to remain in the study but allow study staff to continue with chart 
reviews. No study activities will occur in Safe Harbor or in the UAB Hospital Palliative Care unit. 
In some unique circumstances, the PI may judge it not in the participants’ interest to continue with the 
study. In such instances the participant will be withdrawn. 
 
Discharge 
Prior to discharge, a number of assessments will be conducted and the StepWatch removed; a chart review 
will be conducted after discharge. Data collected from the EMR will include hospital length of stay, discharge 
outcome and destination, ICU/CCU stays, admission diagnoses, rehabilitation services, ED visits and 
hospitalizations in the past 6 months, and information to determine the Cumulative Illness Rating Scale-Geriatrics 
(CIRS-G). Participants will be asked to confirm their contact information, as well as the times at which they 
would prefer to be contacted. After discharge, a letter will be sent to the participant thanking them for their 
contribution to the study, reminding them of the post-hospital follow-ups, and providing them with study contact 
information. 
 
TABLE 6
Discharge Assessments: to complete on the day of discharge 
Procedure
Length of Time Required of Participants
Frequency of Repetition
Katz ADL
3 minutes
Once
Condensed Memorial Symptom 
Assessment Scale (CMSAS)
5 minutes 
Once 
Gait speed
5 minutes
Once
Chart review
0 minutes   (performed by staff)
Once
Total
13 minutes
 
Post-Discharge Follow-ups 
After discharge, participants will be contacted monthly for the first 6 months, at month 9, and at month 
12 for follow-up assessments. These assessments will occur over the phone, except in the unlikely event that the 
participant is hospitalized at BVAMC or UAB Hospital during the assessment window; in that case, the follow-
up may occur in the participant’s hospital room. Study staff will attempt to contact participants for up to one week 
after the initiation of the calls. If patients have not been reached within five days of their scheduled call date, the 
designated contacts provided by the participant will be contacted to help determine if the participant is out of 
town, hospitalized, admitted to a nursing home, or has died. If the participant cannot be reached within one week 

2021.02.05 Protocol page 11 
 
of the initiation of the follow-up call, that follow-up call will be marked as missing and no further calls will be 
attempted until the next scheduled follow-up. The participant’s EMR will also be reviewed by study staff for 
outcomes of interest including rehabilitation services, ED visits, hospitalizations and discharge diagnoses, nursing 
home placement, hospice services, and death. 
As at baseline, the depression screening tool PHQ – 2 will be administered during each post-discharge 
follow-up to the participant (surrogate responses will not be solicited). If a participant is noted to have a PHQ-9 
≥11, indicating moderate depression, the participant’s VA or UAB primary care physician will be notified by 
study staff, provided the participant isn’t already on an antidepressant or is being followed by mental health. 
If a participant successfully completes a follow-up assessment, a letter will be mailed thanking them for 
their continued participation and reminding them of the next follow-up assessment; when the final follow-up is 
completed, a letter will be sent thanking them for their contribution and stating that their participation has now 
ended. If a participant cannot be successfully contacted for a follow-up, a letter will be sent asking them to please 
contact study staff so that either their contact information can be updated, or so that they may withdraw from the 
study. 
 
 
TABLE 8
Post-Discharge Assessments: Months  3 & 9 
Procedure
Length of Time Required of Participants
Frequency of Repetition
Living situation; self-reported mobility
1 minute
1x/month
Katz ADL
3 minutes
1x/month
Lawton IADL
3 minutes
1x/month
UAB Life-Space Assessment
5 minutes
1x/month
EQ-5D-3L (quality of life index)
5 minutes
1x/month
PHQ-2 (& PHQ-9, as appropriate) 
         (depression screening tool)
2 – 6 minutes 
1x/month 
Falls, ED visits, & hospitalizations
1 - 6 minutes
1x/month
Social network change question 
1 minute
1x/month
If social network change question is 
positive: Lubben Social Network Scale
0 – 7 minutes 
0-1x/month 
Chart review
0 minutes   (performed by staff)
1x/month
Total
21-37 minutes
 
 
 
 
TABLE 7
Post-Discharge Assessments: Months 1, 2, 4, & 5 
Procedure
Length of Time Required of Participants
Frequency of Repetition
Living situation; self-reported mobility
1 minute
1x/month
Katz ADL
3 minutes
1x/month
Lawton IADL
3 minutes
1x/month
UAB Life-Space Assessment
5 minutes
1x/month
EQ-5D-3L (quality of life index)
5 minutes
1x/month
PHQ-2 (& PHQ-9, as appropriate) 
         (depression screening tool)
2 – 6 minutes 
1x/month 
Falls, ED visits, & hospitalizations
1 - 6 minutes
1x/month
Chart review
0 minutes   (performed by staff)
1x/month
Total
20-29 minutes

2021.02.05 Protocol page 12 
 
TABLE 9
Post-Discharge Assessments: Months 6 & 12 
Procedure
Length of Time Required of Participants
Frequency of Repetition
Living situation; self-reported mobility
1 minute
1x/month
Katz ADL
3 minutes
1x/month
Lawton IADL
3 minutes
1x/month
UAB Life-Space Assessment
5 minutes
1x/month
EQ-5D-3L (quality of life index)
5 minutes
1x/month
PHQ-2 (& PHQ-9, as appropriate) 
         (depression screening tool)
2 – 6 minutes 
1x/month 
Falls, ED visits, & hospitalizations
1 - 6 minutes
1x/month
Lubben Social Network Scale
7 minutes
1x/month
Chart review
0 minutes   (performed by staff)
1x/month
Total
27-36 minutes
Withdrawal from the study 
We are sensitive to the fact that our study population consists of hospitalized patients. It is possible that 
participants may receive news while in-hospital that is totally unrelated to our study (e.g., a cancer diagnosis,) 
that causes them emotional distress, and that the in-hospital assessments may therefore seem more burdensome 
than it did at the time of consent. Should a participant display such distress during assessments or interventions, 
study staff will ask if the participant would like to continue the study activity at another time or withdraw. The 
participant’s wishes will be followed. However, if the participant’s distress persists, the participant may be 
withdrawn if the PI determines that further participation in the study is not in that person’s best interest. The PI 
and study coordinator have significant experience assessing in-hospital geriatric patients at the Birmingham VA 
and UAB Hospital, and are familiar with such situations. 
 
Statistical considerations 
Sample Size Calculations 
Our primary aim is to evaluate the impact of the mobility program on mobility in the year after hospital 
discharge using the UAB Life-Space Assessment (LSA). In our previous small VA-funded study of a mobility 
intervention, patients in the MP group had a mean LSA score that was approximately 10 points highepr than in 
the UC group at four weeks’ post-discharge. It is our expectation that the current study will replicate these 
results; specifically, that the 10-point difference will be apparent at 1-month post-discharge and persist 
thereafter. As described below, the primary statistical technique to address the primary aim will be mixed 
effects models. Assuming an exchangeable covariance structure across the repeated observations, a sample size 
of 190 participants provides greater than 90% power to detect a persistent 10-point difference in LSA scores at 
the α = .05 level. We must also consider the reduced effective sample size due to clustering. It is a common 
practice to calculate the intraclass correlation (ICC) among clusters as a measure of how much more similar 
members of the same cluster are to each other than to the overall population. In this setting, we recognize that 
subjects at UAB may differ from subjects at the VA, leading to differences in the ICC.  However, we still 
expect much more variability to come from individual patient factors than from the units. Using the data from 
our recently completed VA longitudinal study, we calculated an ICC for the LSA that rounded to 0; including 
data from UAB resulted in an ICC approximately 4 times larger.  Assuming an ICC of 0.004 and subjects 
spread across 9 units, a sample size of 206 yields an effective sample size of 190 observations.  In our recently 
completed VA longitudinal study during which patients were followed for 6 months after hospital discharge, 
80% of the veterans completed at least 5 of the 6 monthly post-hospital assessments. We had 23 deaths and 3 
withdrawals over the 6 months of follow-up among the 200 veterans in the study. Thus, in order to have an 
adequate (i.e.206) sample size at 12-months, 258 patients will be enrolled allowing for patient losses due to 

2021.02.05 Protocol page 13 
 
death or drop outs.  Thus, while adding units from UAB to the study does increase the required sample size 
slightly due to the larger ICC, this is offset by the larger number of potential subjects that can be recruited. 
 
Analytic Approach (for each specific aim) 
Descriptive statistics including mean, standard deviations, distribution, maximum and minimum values 
for the study variables will be calculated. Data will be examined graphically and by summary statistics for outliers 
and distributional properties (e.g., normality, skewness) that may lead to transformations or nonparametric 
analyses where indicated.  
To analyze differences in LSA while accounting for changes in units over time, we will use a stepped-
wedge design (Figure 4, above), a variation of cluster randomization in which each cluster is eventually assigned 
to intervention.21 By beginning with a pre-intervention period and implementing the interventions in ‘steps’ at set 
times, each unit serves as its own control, with pre-intervention observations used to estimate any underlying 
long-term or seasonal trends with precision so that effects from the intervention can be distinguished from these 
‘secular’ trends. While the standard stepped-wedge design treats time in discrete blocks (the ‘steps’), this trial 
will be able to provide more robust estimates of secular trends because observations are linked to the date of each 
patient’s admission, providing a much finer temporal resolution.  To understand the secular trends, we will start 
by examining smoothed plots of LSA over time overall and stratified by unit to identify especially large temporal 
fluctuations that may indicate unanticipated changes in processes or personnel. We will then model LSA during 
the time prior to the initiation of the intervention using mixed models,22 to account and test for heterogeneity 
among hospital units (in both means and trends) and possible nonlinearities. While secular trends must be 
accounted for in the final models, results from this preliminary analysis will inform whether potential trends can 
be considered to be linear, and whether all units can be considered to have the same trends over time.  
Informed by the modeling of secular trends, the final models will add in indicator terms for whether the 
observation occurred before or after the intervention, in addition to the appropriate modeling of secular trends. 
Additional more sophisticated modeling will evaluate the trends in the outcomes over time in the post-intervention 
periods to see whether temporal trends differ pre-and post- intervention.  All statistical tests will be two-sided and 
will be considered to be significant if the associated p-value is <0.05.  All analyses will be intention-to-treat based 
on the unit’s assignment at the time of a patient’s admission, and missing data will be imputed using a multiple 
imputation strategy, based on the characteristics of the data. 
AIM 1: To test the effectiveness of a mobility program on recovery to pre-hospital mobility status or better 
and reduction of adverse outcomes in the year after hospitalization.  
To test the effectiveness of the intervention on mobility, LSA scores and changes in LSA scores for 
patients in the control condition will be compared to LSA scores from patients in the intervention condition.  
Mixed models will be used to examine and compare mean LSA over time with time considered a random effect. 
An indicator term will be included to denote whether the observation was from the period prior to or after 
implementation of the intervention. The indicator term will represent whether there was an overall difference in 
the LSA during the intervention period versus the pre-intervention period, and its statistical significance in the 
model for each outcome will be the primary test of whether the intervention had a significant effect on LSA.  A 
priori we believe that an exchangeable covariance structure will be most suitable for the data. For the secondary 
hypotheses, i.e., self-reported outcomes for driving (yes/no) and ability to walk ¼ of a mile (yes/no), generalized 
linear mixed models (GLMMs) that account for repeated measures will be used to compare pre- and post-
intervention periods. Given the randomized nature of the study design, adjustment for potential confounders will 
likely be unnecessary as they are expected to be equally distributed between the groups. However, as noted above, 
we will confirm that any potential confounders, e.g., age, length of hospitalization, and disease burden score 
(Cumulative Illness Rating Scale-Geriatrics, or CIRS-G23) are indeed similar between the pre- and post-
intervention periods and, should any not be, we will adjust for them in the statistical models provided they are not 
deemed to be consequences of the intervention. 
To test the effectiveness of the intervention on adverse outcomes, we will use mixed models and GLMMs 
to model changes in functional decline (ADLs and IADLs), number of ED visits, and number of hospitalizations 
with an approach similar to the above.  To test the effectiveness of the intervention on nursing home admission 

2021.02.05 Protocol page 14 
 
and death, we will use Cox proportional hazards models to compare the time from hospital discharge to the time 
to event between the MP and UC groups, adjusting for potential covariates.  Due to the potential interrelationship 
between risk of nursing home admission and risk of death, competing hazards will be used to model the time to 
occurrence of the first event.  Right censoring of participants will occur with dropout due to any reason (death, 
loss to follow-up, conclusion of the study period, etc.). Multiple imputation techniques will be used to offset 
potential bias due to missing predictors in the models.  
AIM 2: To identify characteristics which modify the effect of the mobility intervention on recovery to pre-
hospital mobility status or better and reduction of adverse outcomes in the year after hospitalization.  
Potential effect modifiers include pre-admission ADL and LSA, cognitive function, level of in-hospital 
mobility, depressive symptoms, and social support. For continuous variables, e.g., activities of daily living score, 
overall distributions will be reviewed and categorized as low, medium and high based on tertile cut-points. To 
test for significant effect modification, single second level interaction terms, combining pre-/post-intervention 
indicators with potential effect modifiers, will be added to mixed models. Resulting F-tests for the interaction 
terms will be reviewed and p-values <0.05 identified as significant. Examination of potential effect modifiers 
based upon their tertile groupings not only allows for the identification of significant factors but also has the 
added benefit of examining factor’s dose effect, providing additional internal validity to the analysis. 
 
F. ECONOMIC CONSIDERATIONS: Describe any material inducements that will be offered to subjects in 
return for their participation: e.g., direct payment, free services, etc. Describe any schedule of payment to 
subjects based on their complete or partial participation. Will early withdrawal from the study result in a 
reduced payment? Does it make a difference whether it is the subject or the investigator who decides to 
terminate the subject's participation? Explain any bonus a subject may receive for completion of the study. 
These partial or bonus payments must also be explained in the consent form. 
 
Each participant will receive a payment of $20 after completion of the in-hospital portion of the study. 
Any participant who enrolls will receive $20 compensation, regardless as to whether or not the participant 
completes all requested study activities, withdraws, or is withdrawn by the investigator. This payment will be 
made after the participant is discharged from the hospital. 
Each participant will receive one payment of $10 for each post-discharge follow-up that is completed: 
One follow-up will be conducted every month (30 days) after discharge for six months; one follow-up will be 
conducted 9 months after discharge; and a final follow-up will be conducted 12 months after discharge, for a total 
of 8 follow-up assessments. These payments will be made individually, as each follow-up is completed. Follow-
ups that are not completed due to withdrawal, inability to reach the participant, or any other reason will not receive 
payments. Thus, each participant will have the opportunity to receive up to $80 for completing post-discharge 
follow-ups, for a potential total of $100 for full participation in the study.  
UAB participants will be paid at the same rate and on the same schedule as BVAMC participants. 
Compensating UAB participants will involve providing the BVAMC Research Financial Administrative 
Assistant with UAB participants’ names, addresses, and social security numbers. S/he will route the information 
through established VA channels for participant payment.  
 
G. SUBJECT POPULATION: Describe the requirements for the subject population including the total 
number of subjects and controls and their ages. If special groups -- e.g., prisoners, children, fetuses, the 
mentally disabled -- are part of the subject population, please indicate this. 
 
List the specific inclusion and exclusion criteria. 
258 patients, age ≥ 50 years admitted for any medical illness (e.g. pneumonia, heart failure, COPD 
exacerbation, or other medical (versus surgical) indication for hospitalization) to one of the five hospital wards 
of the Birmingham VAMC or one of four hospital units at UAB Hospital will be recruited within 48 hours of 
hospitalization, and followed throughout their hospitalization and for one year after hospital discharge.  
 

2021.02.05 Protocol page 15 
 
Inclusion criteria include: 
 Age ≥ 50 years 
 Medical admission to BVAMC wards 4A, 4B, 5A, 5B, or 6B; or to UAB Hospital (3 Hospitalist units 
and Tinsley Harrison service) 
 Direct admission to BVAMC or UAB Hospital, or from ED (not from ICU) 
 ≤48 hours since hospital admission 
 Access to a telephone after discharge 
 
Exclusion criteria include: 
 Inability to walk across a small room 2 weeks prior to admission 
 Inability to stand safely with assistance 
 Having a diagnosis deemed by the primary physician to be a contraindication to walking (pulmonary 
embolus, unstable angina, etc.) 
 Being on hospice or comfort care 
 Non-English speaking, blind, or deaf 
 Being enrolled in other VA or UAB mobility research studies 
 Isolation precautions for c. difficile, tuberculosis, radioactive treatment, or similar 
 Suicidal ideation 
 
Older adults who are either demented or delirious will have the opportunity to participate in this study. Among 
older adults hospitalized with acute illness, delirium and dementia are common, affecting up to 25% of the 
population. Exclusion of this group, who may have very different trajectories of recovery after hospitalization, 
would have a significant impact upon the generalizability of the research results. More importantly, this research 
may uncover methods by which we can improve hospital care for this vulnerable group who often do poorly when 
hospitalized. 
 
Screening to determine if a participant has dementia or delirium will occur prior to signed informed 
consent through use of two standard assessment tools, the Mini Cognitive Assessment (Mini-Cog) and the 
Confusion Assessment Method (CAM). If a patient scores positively for dementia or delirium based on these 
tools, the patient’s physician will be consulted to determine whether the patient has decision-making capacity. If 
there is documentation in the EMR or VISTA that the patient does not have decision-making capacity, informed 
consent will be sought from the appropriate legally authorized representative. Patients with dementia or delirium 
will be included only if they assent to the study themselves. 
 
H. RISKS: Describe and assess any risks -- physical, psychological, social, economic, legal, or other. If other 
methods of research present lesser risks, describe those, if any, that were considered and why they will not be 
used. In general, risks to subjects must be minimized by (a) using procedures which are consistent with 
sound research design and which do not unnecessarily expose subjects to risk and (b) whenever appropriate, 
by using procedures already being performed on the subjects for diagnostic or treatment purposes. Describe 
the procedures you have taken to minimize these risks. 
For all research involving any risk of physical injury, these risks must be specified. If there are none, state: 
"There are no risks of physical injury." If there are risks of physical injury, there should be for each injury a 
careful estimate of its probability and severity as well as of its potential duration and the likelihood of its 
reversibility. 
 
The potential risks for the proposed study include a slight risk of skin irritation due to the StepWatches; falls; 
increased symptoms such as fatigue or shortness of breath due to ambulation during testing or mobility sessions; 
a slight risk of distress due to the nature of some study questions; and loss of confidentiality. 
 

2021.02.05 Protocol page 16 
 
Skin irritation: The StepWatches have been used in our previous BVAMC study with only a single instance of a 
participant experiencing discomfort (in this case, due to the StepWatch making a previously-received bug bite 
itch). Study staff will evaluate the participant’s skin under and around the StepWatch each day to assure there is 
no erythema, and will remove the StepWatch if concerns arise. We do not expect that participants will experience 
any skin irritation during this study.  
 
Falls: Falls are common during hospitalization; however, the PI has never had a fall occur during a study walking 
session in over ten years of research at UAB, and there were no falls during study sessions in our previous, similar 
study at the Birmingham VA. We do not expect any participants will fall during the study sessions. 
 
Shortness of breath and fatigue: These can occur for some patients when engaging in out-of-bed activities. As the 
testing and mobility sessions involve simply standing and walking as tolerated by the participant, we expect only 
a slight increased risk of these symptoms. 
 
Psychological distress: The PHQ-2 and PHQ-9 ask questions designed to determine if a patient is depressed; the 
risk of experiencing distress from these questions is very slight. We expect that participants will experience no to 
very mild distress during the PHQ-2 and PHQ-9.   
 
Confidentiality: We do not expect any breaches in confidentiality during the course of this study. Study staff will 
make every effort to prevent any breaches of confidentiality or privacy, and will follow HIPAA guidelines 
concerning PHI. 
 
 
I. CONSENT PROCEDURES: Describe consent procedures to be followed, including how, where, and by 
whom informed consent will be obtained. The consent form should be appended to the protocol exactly as 
you plan to submit it to the funding agency and to the subject. 
 
The PI, study coordinator, and TBN study staff will conduct the informed consent discussion in the 
patient’s hospital room. The door will be closed, or the curtain will be pulled to ensure privacy. Efforts will be 
made to ensure that the discussion occurs while no other health care procedures are in process, especially those 
that could be considered stressful (e.g., blood draws). Consenting staff will describe the study, invite the patient 
to participate, and answer any questions. If LAR consent is necessary, staff will follow the same steps with the 
LAR. If they are interested, consenting staff will read then the consent form and HIPAA authorization along with 
the patient (and LAR, as appropriate), allowing time for questions. Consenting staff will emphasize statements in 
the consent form that participation is completely voluntary and that non-participation will in no way impact their 
medical treatment. 
 After going through the consent form, the patient/LAR will be asked again if there are any questions, and 
once all questions are addressed the patient/LAR will be invited to sign the consent form. If they would like more 
time to consider participation, consenting staff will allow them as much time as they wish. However, since study 
participants must enroll within 48 hours of admission, it is possible that a patient may delay making a decision 
until they are no longer eligible for the study. In such a situation, the patient/LAR will be thanked for their interest 
but will not be enrolled in the study. At no time will patients/LARS be pressured in any way to enroll before they 
are comfortable due to the 48-hour constraint. 
The PI and the study coordinator have multiple years’ experience recruiting inpatients as participants for 
other mobility studies both at the VA and at UAB, and are sensitive to the stressful nature of hospitalization. Great 
consideration will be given to the patients’ situations and recruitment will be conducted with high sensitivity and 
awareness of this burden.    
 
 

2021.02.05 Protocol page 17 
 
J. PROTECTION OF SUBJECT: Describe procedures (including confidentiality safeguards) for protecting 
against or minimizing injuries (physical, psychological and social) and provide an assessment of their likely 
effectiveness.  
 
The potential risks for the proposed study include a small risk of skin irritation due to the StepWatches; 
falls and increased symptoms such as fatigue or shortness of breath due to increased ambulation during tests; a 
slight risk of psychological distress; and loss of confidentiality.  
 
Skin Irritation: To address the small risk of skin irritation, study staff will check the skin under and near 
StepWatch at least once a day for signs of erythema. New Velcro straps will be provided whenever the old ones 
become wet or soiled. If signs of erythema are noted, the pedometers will be moved to the contralateral side or 
removed entirely, as appropriate. Flyers with the study’s pager number will be placed on or near the whiteboard 
located in all patient rooms, and nursing will be asked to call study staff if there are any questions about the 
pedometers. Previous studies by the PI using the same pedometers at the Birmingham VA Medical Center had no 
skin issues develop. To date we have had < five patients remove the StepWatch independently, with the most 
common reason cited by the patients being anticipation of discharge.  
 
Falls, shortness of breath, and fatigue: To address the issue of falls and of worsening symptoms such as fatigue 
and shortness of breath while walking, a physical therapist (Dr. Diane Clark, PT, PhD) will train study staff on 
safe ambulation techniques. If a patient is weak, defined as being unable to walk without moderate assistance, or 
has a BMI greater than 35, two study staff will walk with the patient. If there are not sufficient study staff for this 
to be possible, the session or test will be skipped. Patients will wear a gait belt whenever they are working with 
the study researchers. Participants will be asked to rate their exertion using the Perceived Exertion Index during 
mobility sessions, and staff will encourage participants to rest if they become tired or short of breath. 
The level of mobility recommended to the MP participant 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. For example, if a patient could stand at the bedside independently, but required standby 
assistance for walking, the patient would be encouraged to sit on the side of the bed for meals and stand up beside 
the bed for 3-5 minutes every two hours as able. To assure patient safety, patients will be instructed not to attempt 
to transfer or walk without nursing assistance if deemed to be dependent in these activities. MP participants will 
be provided with a basic safety procedure handout that will include safe mobility strategies. 
 
Psychological distress: As the PHQ-2 and PHQ-9 ask questions designed to determine if a patient is depressed, 
there is a slight risk of experiencing distress from these questions. We expect that participants will experience no 
to only very mild distress while answering these questions.  However, if the patient experiences distress, the PHQ 
will be halted and the PI notified. The PI may notify the participant’s attending physician, as she deems 
appropriate. In addition, if the participant scores ≥11 on the PHQ-9, the patient’s BVAMC or UAB physician will 
be notified. 
 
Confidentiality:  To help protect confidentiality, participants will be interviewed in their ward rooms with the 
door closed or the curtain pulled; telephone assessments will be conducted from private offices with the doors 
closed. To help protect privacy, participants will be provided with appropriate gown coverage if they walk in the 
hallways during study walking sessions.  
For Birmingham VAMC veterans, data will be collected using paper records; while on the wards, these 
will be physically present with study staff at all times. Paper records will be stored in locked file cabinets behind 
locked doors in study staff offices in the BVAMC, rooms 8211, 8223, 8224 and 8218. As with the paper records, 
active StepWatches will be physically present with study staff at all times (when not worn by the participant). No 
hard-copy data will be removed from the VA protected environment, nor will any PHI be transmitted 
electronically. 

2021.02.05 Protocol page 18 
 
Data will be entered by study staff into MS Office applications under VA license, and will be stored on 
the secure research server (birresearch) in a secure folder to which only study staff will have access. StepWatch 
data will likewise be stored in this secure folder. No study data will be stored in temporary files or on a computer 
hard drive. Information from this study will only be reported in aggregate for research purposes without the 
possibility of identifying individuals in the study. Data retention and data destruction will follow current 
regulations. 
The PI will have ultimate responsibility for the security of the data. Study staff will contact the PI and 
study coordinator immediately in the case of any suspected or confirmed theft, loss, or unauthorized access of 
data, or of non-compliance with security controls. The PI or study coordinator will report incidents to the PO and 
ISO by phone and/or email, and to the National Service Desk by submitting a ticket via phone, email, or online 
ticket submission system [see VHA Handbook 1200.05 ¶10j, VHA Handbook 1058.01 ¶11.a, VA Handbook 
6500, Appendix D, and VHA Handbook 6500.2]. 
Study personnel who leave the research team will have their access to the secure folder terminated and 
will turn in all keys to offices and file cabinets upon leaving the team. 
UAB participants’ data will be stored in UAB facilities per UAB guidelines. This data will be de-identified 
and combined with de-identified data from VA participants for the purposes of conducting analysis.  
 
Data Safety and Monitoring Board (DSMB) The Data Safety and Monitoring Board will be charged with 
recommending changes in the study protocol or closure of the study if the incidence of falls or another adverse 
event in the intervention group at BVAMC is significantly greater than that observed in the control group at 
BVAMC. The board’s membership will include a physician, a physical therapist and a nurse. The DSMB will 
meet quarterly either in-person or by conference call to discuss the study and any issues or concerns. Incidents 
will be reported to the DSMB by email. 
The following incidents which occur at BVAMC will be reported to the DSMB and IRB immediately: 
1. Falls by participants that occur during the inpatient portion of the study 
2. Open wounds (Stage II or greater pressure ulcers indicating a breach of the skin’s integrity) 
under the area of the StepWatch 
The following incidents which occur at BVAMC will be reported to the DSMB quarterly: 
1. Falls by participants that occur after the inpatient portion of the study, but while enrolled, 
together with statistics on the current fall rate at BVAMC 
2. Participants’ deaths that occur after the inpatient portion of the study, but while enrolled 
3. Emergency department visits that occur after the inpatient portion of the study, but while 
enrolled 
4. Rehospitalizations that occur after the inpatient portion of the study, but while enrolled 
5. Participant transferred to ICU/CCU or Safe Harbor during the inpatient portion of the study 
6. Participant dies during the inpatient portion of the study 
7. Skin irritation in the immediate vicinity of the StepWatch 
 
AEs, SAEs, and other incidents which involve UAB participants will be reported to the UAB IRB. 
 
K. POTENTIAL BENEFITS: Assess the potential benefits to be gained by the individual subject, as well as 
benefits which may accrue to society in general as a result of the planned work. 
For the group of patients who receive the hospital mobility intervention, it is expected they will maintain 
or improve their mobility to a greater degree than those in the usual care group. As ability to walk is a key 
component of all basic activities of daily living, the MP group may also experience an improvement in their ADL 
ability to a greater degree after hospital discharge. As mobility disability is associated with a reduction in quality 
of life, the MP group may experience an improvement in quality of life.  
It is expected that there will be little direct benefit to those participants who are randomized to the control 
group. However, they will be visited three times a day for social visits, which may increase their feeling of 
wellbeing.  

2021.02.05 Protocol page 19 
 
 
L. THE RISK-BENEFIT RATIO: This section should consist of the investigator's explanation of how he or 
she concluded that the risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, 
and the importance of the knowledge that may reasonably be expected to result. 
The risks to the subjects are very small, whereas the results of this study will add substantively to what is 
currently known about how to improve outcomes due to low mobility for middle-aged and older adults who have 
a hospitalization. Functional decline, loss of mobility, and nursing home admission are well-recognized negative 
outcomes associated with hospitalization, and available evidence suggests low mobility to be a contributor to 
these adverse outcomes; determining the effectiveness of a hospital mobility program could have significant 
impact on functional decline and loss of mobility for hospitalized patients. The potential benefits are great if the 
study allows for the development of a hospital mobility program intervention that could ultimately decrease loss 
of mobility and functional decline and reduce ED visits, hospitalizations and the need for nursing home care after 
hospitalization. 
 
 
References: 
1. Brown CJ, Friedkin RJ, Inouye SK. Prevalence and outcomes of low mobility in hospitalized older patients. J 
Am Geriatr Soc 2004;52:1263-1270. 
2. Brown CJ, Redden DT, Flood KL, Allman RM. The underrecognized epidemic of low mobility during 
hospitalization of older adults. J Am Geriatr Soc, 57(9):1660-1665, 2009.  
3. Boyd CM, Landefeld CS, Counsell SR, Palmer RM, Fortinsky RH, Kresevic D, Burant C, Covinsky KE. 
Recovery of activities of daily living in older adults after hospitalization. J Am Geriatr Soc. 2008;56(12): 2171-
2179.  
4. Suesada MM, Martins MA, Carvalho CRF. Effect of short-term hospitalization on functional capacity in 
patients not restricted to bed. Am J Phys Med Rehabil. 2007;86:455-462. 
5. Mundy LM, Leet TL, Darst K, Schnitzler MA, Dunagan WC. Early mobilization of patients hospitalized with 
community-acquired pneumonia. Chest 2003;12:883-889. 
6. Kalisch BJ, Lee S, Dabney BW. Outcomes of inpatient mobilization: a literature review. Journal of Clinical 
Nursing. 2013;23:1486-1501. 
7. Hastings SN, Sloane R, Morey MC, Pavon JM, Hoenig H. Assisted early mobility for hospitalized older 
veterans: preliminary data from the STRIDE program. J Am Geriatr Soc. 2014 Nov; 62(11): 2180–2184.  
8. Siu AL, Penrod JD, Boockvar KS, Koval K, Strauss E, Morrison RS. Early ambulation after hip fracture: effects 
on function and mortality. Arch Intern Med. 2006;166:766-771. 
9. Brown CJ, Foley KT, Lowman JD, Roth DL, Allman RM. Impact of a hospital walking program on function 
and community mobility. J Am Geriatr Soc. 2012;60 (Suppl):S5. 
10. Baker PS, Bodner EV, Allman RM. Measuring life-space mobility in community-dwelling older adults. J Am 
Geriatr Soc 2003;51:1610-1614.  
11.Parker M, Baker PS, Allman RM. A life-space approach to functional assessment of mobility in the elderly. J 
Gerontol Soc Work 2001;35:35-55. 
12. Peel C, Sawyer-Baker P, Roth DL, Brown CJ, Allman RM. Assessing mobility in older adults: the UAB study 
of aging life-space assessment. Phys Ther 2005;85:1008-1019. 
13. Brown CJ, Roth DL, Allman RM, Sawyer P, Ritchie CS, Roseman JM. Trajectories of Life-Space Mobility 
after Hospitalization. Ann Intern Med 150(6):372-378, 2009.  
14. Gill TM, Gahbauer EA, Murphy TE, Han L, Allore HG. Risk factors and precipitants of long-term disability 
in community mobility: a cohort study of older persons. Ann Intern Med. 2012;156(2):131-140. 
15. Borson S, Scanlan J, Brush M, Vitaliano P, Dokmak A. The mini-cog: a cognitive ‘vital sign’ measure for 
dementia screening in multi-lingual elderly. Int J Geriatr Psychiatry 2000;15:1021-1027. 
16. Borson S, Scanlan J, Chen P, Ganguli M. The Mini-Cog as a screen for dementia: validation in a population-
based sample. J Am Geriatr Soc 2003;51:1451-1454. 

2021.02.05 Protocol page 20 
 
17. Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the Confusion 
Assessment Method: a new method for detection of delirium. Ann Intern Med 1990;113:941-948. 
18. Kroenke K, Spitzer RL, Williams JB. The Patient Health Questionnaire-2: validity of a two-item depression 
screener. Med Care. 2003;41(11):1284. 
19. Henkel V, Mergl R, Kohnen R, Maier W, Möller HJ, Hegerl U. Identifying depression in primary care: a 
comparison of different methods in a prospective cohort study. BMJ. 2003;326(7382):200–201. 
20. Modus (StepWatch) Website. https://modushealth.com/?module=pages&uri=stepwatch_trade. Accessed May 
19, 2015. 
21. Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials. 
2007 ;28(2):182–91. 
22. Brown H, Prescott R. Applied Mixed Models in Medicine. Wiley, Chichester, 2nd edition, 2006. 
23. Miller G, Paradis CF, Houck PR, Mazumdar S, Stack JA, Rifai AH, et al. Rating chronic medical illness 
burden in geropsychiatric practice and research: application of the Cumulative Illness Rating Scale. Psychiatry 
Res. 1992;41(3): 237-248.