Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT03888027 |
Other study ID # |
ReDA 6072 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 6, 2019 |
Est. completion date |
April 2024 |
Study information
Verified date |
March 2024 |
Source |
Lawson Health Research Institute |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Patients admitted to hospital typically experience periods of decreased activity or bed-rest.
This reduced activity level leads to deconditioning - a loss of muscle mass, muscle strength
(by 2-5% per day), and muscle shortening. Even among patients who were ambulatory at the time
of admission, deconditioning has been linked with deleterious effects, such as increased
rates of falls, functional decline, and frailty. Furthermore, it has been suggested that the
physiological stresses associated with hospitalization - including deconditioning, as well as
sleep deprivation and poor nutrition - makes discharged patients vulnerable to recurrent or
new illnesses and to frailty. This physiological stress-induced vulnerability has been coined
"post-hospital syndrome" and is thought to have a role in most hospital readmissions. The
investigators hypothesize that by engaging ambulatory patients to walk with trained
volunteers, patients will increase their amount of walking, have less deconditioning and
functional decline, and consequently, fewer falls. Furthermore, the investigators anticipate
that patients who walk with a trained volunteer will have reduced length-of-stay in hospital
and decreased likelihood of readmission. Finally, as shown in other similar programs, the
investigators anticipate an overall improvement in the patient experience. The investigator's
novel initiative focuses on a single, volunteer-based intentional ambulation program that can
deliver the benefits of early mobility in a cost-effective way. The program design engages
trained volunteers to increase patient ambulation in a way that both increases patient
mobility and reduces healthcare professionals' workload.
Description:
WalkMORE is a single-center randomized controlled trial. The investigators will enroll up to
800 ambulatory patients admitted to the Internal Medicine unit (located on the 4th floor of
University Hospital) who are >18 years of age and are anticipated to require a >48 hour
hospital admission. A maximum of 6 patients will be assigned to each treatment arm at any
given time. The investigators will recruit patients into the WalkMORE program over a 2 year
period. The research coordinator (RC) will screen patients admitted to the Internal Medicine
unit in the preceding 24-hour period to identify patients who fulfill the eligibility
criteria. Patients will be randomized via REDCap (Research Electronic Data Capture), a
secure, centralized web-based randomization module to:
1. Standard of care; or
2. WalkMORE Ambulation program + Standard of care. Patients will ambulate with a trained
WalkMORE Volunteer two times per day; once in the morning (0900-1200 hrs) and once in
the afternoon (1300-1600 hrs), Monday- Friday, until hospital discharge. Patients
randomized to the WalkMORE intervention will be assessed daily by the RC to ensure
patients remain fit for independent ambulation. The duration of each walking session
will be determined daily by the RC and the medical team.
After obtaining written informed consent from eligible patients the RC will randomize
patients, collect demographics and hospital admission details from patients' hospital charts
and perform the Barthel Index and complete the Charlson Comorbidity Index (CCI) for all
patients. The Barthel Index (BI) measures the extent to which patients can function
independently and has mobility in their activities of daily living (ADL). The Charlson
Comorbidity Index categorizes and scores the comorbidities of patients. The CCI can be used
to predict short term and long-term outcomes such as function, hospital length of stay and
mortality rates. The CCI will be completed using information gathered from patients' hospital
chart.with all patients.
All patients will be assigned a scientific pedometer on the day of randomization. The modus
Health StepWatchâ„¢ is an activity monitor worn on the ankle via a velcro strap. It is a small,
lightweight device that will count and record patients' steps throughout hospital stay,
ending at hospital discharge. Research personnel will be responsible for fitting the
StepWatch monitor to patients' ankle. The device is smaller than a deck of cards (7.5 x 5.0 x
2.0 cm) and weighs 38 grams.
Frailty and de-conditioning will be measured on Study Day 3. Frailty will be assessed using
the Jamar Hand Dynamometer. Patients are instructed to squeeze the handle of the instrument
with their maximum force for three seconds; the peak-hold (in kilograms) is recorded on the
instrument. Three successive peak-hold measurements will be recorded. The device measures 10
x 20 x 33cm and weighs 1.3 kg. Deconditioning will be measured using the Timed Up and Go
(TUG) test, patients will be asked to stand up from a chair, walk three metres, turn around,
and walk back to the chair and sit.
After hospital discharge the RC will follow up with patients for 2 brief telephone
interviews. On the third day after discharge, Patient Satisfaction surveys will be conducted
by the RC to assess patient satisfaction with their hospital experience and with the WalkMORE
program. On day 30 after randomization, the RC will contact patients to conduct a brief
interview consisting of: a health status survey (EQ-5D), a functional status assessment
(Barthel Index) and to collect data regarding clinical outcomes (ER visits,
re-hospitalizations, and falls). Each telephone interview is expected to last approximately
10 minutes.