HospitalizationNCT02674503
Impact of a Mobility Program
A study testing Walking and Friendly visit in people with Hospitalization, run by VA Office of Research and Development at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hospitalization
- What is being tested?
- Walking and Friendly visit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Dec 2016to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Being on hospice or comfort care
- Being in a semi-private room with another currently enrolled participant
- Non-English speaking, blind, or deaf
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Birmingham VA Medical Center, Birmingham, AL
Birmingham, Alabama, 35233
UAB Hospital
Birmingham, Alabama, 35294
About this study
Official title: Impact of a Hospital Mobility Program on Function After Discharge
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.
Read the detailed description
For this high impact study the investigators propose to use a stepped wedge cluster randomization design on five VA hospital wards to compare a mobility program (MP) to usual care (UC) among a cohort of Veterans age 50 years. The investigators will examine pre to post-hospital mobility and adverse outcomes including functional decline, nursing home admission, emergency department (ED) visits, hospitalization and death in the MP and UC groups in the year after hospital discharge. The primary outcome of mobility will be measured by the University of Alabama at Birmingham (UAB) Life-Space Assessment (LSA).10-13 Secondary measures of mobility will include self-reported ability to walk mile and drive a car, as described by Gill, et al.14 The investigators will identify patient specific characteristics that modify the effect of the mobility intervention on post-hospital mobility and adverse outcomes to determine which hospitalized patients are most likely to benefit from this intervention.
Note, Secondary outcome measures were curtailed as the original PI, Dr. Brown, retired.
- Conditions
- Hospitalization
- Being tested
- Walking, Friendly visit
- Keywords
- Walking, Hospitalization, Randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WalkingBehavioural
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 visitBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intensive | Experimental | 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. Receives: Behavioral: Walking |
| Friendly visit | Placebo comparator | 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. Receives: Behavioral: Friendly visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. The range in scores is 0-100 with higher scores representing better life space mobility.
Measured: One year
Secondary outcomes (12)
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.
Measured: One Year
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.
Measured: One year
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.
Measured: One year
Activities of Daily Living (ADLs)
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.
Measured: One Year
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.
Measured: One year
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 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).
Measured: One year
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.
Measured: Baseline only
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%.
Measured: Baseline only
Patient Health Questionnaire (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.
Measured: One year
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.
Measured: One year
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.
Measured: One year
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.
Measured: Average one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study start12 Dec 2016
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HospitalizationStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Cynthia J Brown, MD MSPH, Principal investigator, Birmingham VA Medical Center, Birmingham, AL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02674503
- Sponsor's protocol ID
- E1995-R
- Status last verified
- Mar 2024
- First submitted
- 8 Jan 2016
- Last updated
- 5 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: No detailed plans at this time.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Hospital Mobility Program on Function After Discharge
- ClinicalTrials.gov ID
- NCT02674503
- Acronym / sponsor ID
- E1995-R
- Conditions
- Hospitalization
- Keywords
- Walking, Hospitalization, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 12 Dec 2016 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 4 Feb 2016 (estimated)
- Results
- Posted 5 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive | Experimental | Behavioral: WalkingMP 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. |
| Friendly visit | Placebo comparator | Behavioral: Friendly visitUC 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 50 years admitted to one of the five hospital wards of the Birmingham VA Medical Center (VAMC) for any medical illness, e.g.:
- Patients will be recruited within 48 hours of hospitalization, followed throughout their hospitalization and for one year after hospital discharge.
Key exclusion criteria (9 listed)
- Patients admitted for brief observation will be excluded, e.g.:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WalkingMP 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. | Behavioural | Intensive |
| Friendly visitUC 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. | Behavioural | Friendly visit |
Primary outcome
Life-Space Assessment Score
Time frame: 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.
12 secondary outcomes
Presence of Adverse Outcomes: Rehospitalization
Time frame: One Year
Presence of Adverse Outcomes: Nursing Home Placement
Time frame: One year
Presence of Adverse Outcomes: Death
Time frame: One year
Activities of Daily Living (ADLs)
Time frame: One Year
Presence of Adverse Outcomes (ED Visits, Rehospitalization, Nursing Home Placement, Death)
Time frame: One year
Instrumental Activities of Daily Living (IADLs)
Time frame: One year
Mini Cognitive Assessment (Mini-Cog)
Time frame: Baseline only
Confusion Assessment Method
Time frame: Baseline only
Patient Health Questionnaire (PHQ) -2
Time frame: One year
EuroQOL Five Dimensions Questionnaire (EQ-5D)
Time frame: One year
Lubben Social Network Scale (LSNS-Revised)
Time frame: One year
Level of Hospital Mobility
Time frame: Average one week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. No detailed plans at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia J Brown, MD MSPH principal investigator
Birmingham VA Medical Center, Birmingham, AL
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking and Friendly visit in people with Hospitalization, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Life-Space Assessment Score (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024; AzTrials last refreshed its copy on 27 Oct 2026.