Trial Outcomes & Findings for Impact of a Mobility Program (NCT NCT02674503)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

132 participants

Primary outcome timeframe

One year

Results posted on

2024-07-05

Participant Flow

Dates of recruitment were 12/12/2016 through 10/19/2019. Participant recruited from the inpatient hospital setting.

No significant events in the study that occurred after participant enrollment.

Participant milestones

Participant milestones
Measure	Intensive 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. 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. 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.
Overall Study STARTED	62	70
Overall Study COMPLETED	60	68
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Missing data on n=1 for this measure; not able to calculate score due to missing data

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intensive n=60 Participants 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. 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 n=68 Participants 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. 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.	Total n=128 Participants Total of all reporting groups
Age, Continuous	66.2 years STANDARD_DEVIATION 8.5 • n=60 Participants	66.2 years STANDARD_DEVIATION 9.5 • n=68 Participants	66.2 years STANDARD_DEVIATION 9.0 • n=128 Participants
Sex: Female, Male Female	10 Participants n=60 Participants	5 Participants n=68 Participants	15 Participants n=128 Participants
Sex: Female, Male Male	50 Participants n=60 Participants	63 Participants n=68 Participants	113 Participants n=128 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=60 Participants	0 Participants n=68 Participants	2 Participants n=128 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	56 Participants n=60 Participants	66 Participants n=68 Participants	122 Participants n=128 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=60 Participants	2 Participants n=68 Participants	4 Participants n=128 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=60 Participants	1 Participants n=68 Participants	2 Participants n=128 Participants
Race (NIH/OMB) Asian	0 Participants n=60 Participants	0 Participants n=68 Participants	0 Participants n=128 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=60 Participants	0 Participants n=68 Participants	0 Participants n=128 Participants
Race (NIH/OMB) Black or African American	25 Participants n=60 Participants	26 Participants n=68 Participants	51 Participants n=128 Participants
Race (NIH/OMB) White	30 Participants n=60 Participants	38 Participants n=68 Participants	68 Participants n=128 Participants
Race (NIH/OMB) More than one race	2 Participants n=60 Participants	1 Participants n=68 Participants	3 Participants n=128 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=60 Participants	2 Participants n=68 Participants	4 Participants n=128 Participants
Region of Enrollment United States	60 Participants n=60 Participants	68 Participants n=68 Participants	128 Participants n=128 Participants
Life Space Total Score, mean (SD)	60.1 units on a scale STANDARD_DEVIATION 28.3 • n=60 Participants • Missing data on n=1 for this measure; not able to calculate score due to missing data	66.5 units on a scale STANDARD_DEVIATION 23.2 • n=67 Participants • Missing data on n=1 for this measure; not able to calculate score due to missing data	63.5 units on a scale STANDARD_DEVIATION 25.8 • n=127 Participants • Missing data on n=1 for this measure; not able to calculate score due to missing data
Activities of Daily Living Score, mean (SD)	7.5 units on a scale STANDARD_DEVIATION 1.3 • n=52 Participants • Missing data on n=18 for this measure; not able to calculate score due to missing data	7.6 units on a scale STANDARD_DEVIATION 1.8 • n=58 Participants • Missing data on n=18 for this measure; not able to calculate score due to missing data	7.5 units on a scale STANDARD_DEVIATION 1.6 • n=110 Participants • Missing data on n=18 for this measure; not able to calculate score due to missing data
Instrumental Activities of Daily Living Score, mean (SD)	14.7 units on a scale STANDARD_DEVIATION 2.4 • n=60 Participants	14.9 units on a scale STANDARD_DEVIATION 2.2 • n=68 Participants	14.8 units on a scale STANDARD_DEVIATION 2.3 • n=128 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intensive n=40 Participants 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. 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 n=41 Participants 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. 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.
Life-Space Assessment Score	57.8 score on a scale Standard Deviation 26.7	59.6 score on a scale Standard Deviation 23.3

SECONDARY outcome

Timeframe: One Year

To determine the impact of participation in the mobility program on adverse outcomes, the investigators will measure the frequency of rehospitalization in the MP versus UC groups.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

To determine the impact of participation in the mobility program on adverse outcomes, the investigators will measure the frequency of nursing home placement in the MP versus UC groups.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

To determine the impact of participation in the mobility program on adverse outcomes, the investigators will measure the frequency of death in the MP versus UC groups.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One Year

Participants will be asked to complete the Katz ADL. Specifically, patients will be asked to rate their current level of independence with six activities of daily living (feeding, bathing, dressing, toileting, transferring, and walking across a small room). Scores range from 0-12, with lower scores representing better independence in activities of daily living.

Outcome measures

Outcome measures
Measure	Intensive n=40 Participants 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. 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 n=41 Participants 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. 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.
Activities of Daily Living (ADLs)	7.34 score on a scale Standard Deviation 0.97	7.37 score on a scale Standard Deviation 0.76

SECONDARY outcome

Timeframe: One year

To determine the impact of participation in the mobility program on adverse outcomes, the investigators will measure the frequency of ED visits, hospitalizations as well as death and nursing home admissions including both short and long term placement in the MP versus UC groups.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

Level of independence with Instrumental Activities of Daily Living (IADLs) will be assessed at the same time points as the basic ADLs using the Lawton Index. The IADL index evaluates 8 domains of function including shopping, food preparation, housekeeping, laundry, transportation, handling finances, ability to take own medications and use of the telephone. A summary score ranges from 3 to 24, with higher scores indicating higher levels of independence with the tasks. Score options were trichotomous (1 = unable, 2 = needs assistance, 3 = independent).

Outcome measures

Outcome measures
Measure	Intensive n=40 Participants 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. 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 n=41 Participants 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. 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.
Instrumental Activities of Daily Living (IADLs)	14.0 score on a scale Standard Deviation 3.32	14.8 score on a scale Standard Deviation 1.96

SECONDARY outcome

Timeframe: Baseline only

The Mini-Cog is a brief cognitive screening measure that includes a three-item memory recall and a clock drawing test. The test is scored using a simple algorithm whereby patients who are unable to recall any of the three items are considered demented; those who can recall all three items are deemed not demented; and those with intermediate word recall ability (1 or 2 items) are classified based on the clock drawing test. For persons with intermediate recall ability, if the clock drawing is abnormal, the patient is considered demented and if the clock drawing is normal the patient is not considered demented.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline only

The Confusion Assessment Method (CAM) allows rapid assessment of the presence of delirium. Four clinical features, including 1) Acute onset and fluctuating course; 2) Inattention; 3) Disorganized thinking; and 4) Altered level of consciousness, are assessed. The presence of features 1 and 2 and either 3 or 4 indicates the patient has delirium. The positive and negative predictive values for the CAM are approximately 90%.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

Patients will be asked at each interview the Patient Health Questionnaire (PHQ) - 2, specifically 1) Have you often been bothered by feeling down, depressed, or hopeless?; and 2) Have you often been bothered by little interest or pleasure in doing things? The PHQ-2 has been found to have a sensitivity and specificity of 83% and 92% respectively and is an excellent brief screening tool for depression.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

Patients will be asked to complete the EQ-5D once during the hospital stay, then at months 1, 3, 6, 9, and 12. The EQ-5D-3L is a well-validated measure of quality of life which enables the calculation of a single index value ranging from 0, worst imaginable health to 1, perfect health.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

The Lubben Social Network Scale (LSNS) was designed to measure perceived social support received from family and friends. The LSNS-Revised includes 12 items with scores ranging from 0-60 with higher scores indicating greater perceived social support.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Average one week

All patients will wear a StepWatch throughout the hospitalization to document the level of mobility attained by each patient. The StepWatch is a ankle worn pedometer that documents number of steps taken and when they were taken.

Outcome measures

Outcome data not reported

Adverse Events

Intensive

Serious events: 36 serious events

Other events: 11 other events

Deaths: 10 deaths

Friendly Visit

Serious events: 27 serious events

Other events: 24 other events

Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure	Intensive n=60 participants at risk 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. 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 n=68 participants at risk 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. 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.
General disorders Emergency Department visits	60.0% 36/60 • Number of events 37 • 1 year	39.7% 27/68 • Number of events 41 • 1 year
General disorders Rehospitalization	60.0% 36/60 • Number of events 38 • 1 year	39.7% 27/68 • Number of events 36 • 1 year

Other adverse events

Other adverse events
Measure	Intensive n=60 participants at risk 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. 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 n=68 participants at risk 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. 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.
General disorders skin irritation	18.3% 11/60 • 1 year	35.3% 24/68 • 1 year

Additional Information

Dr. Alayne Markland

Birmingham VA - GRECC Director; Professor at UAB

Phone: 205-558-7067

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place