Clinical trial NCT03888027: WalkMORE: A Volunteer-driven Walking Intervention
Official title: A Randomized Controlled Trial of a Volunteer-driven Walking Intervention to Improve Hospital-associated Deconditioning and Frailty
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Frailty
Deconditioning
Early Ambulation
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2019-03-25
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 Coach two times per day; once in the morning (0900-1200hrs) and once in the afternoon (1300-1700hrs), Monday- Friday, until hospital discharge. Patients randomized to the WalkMORE intervention will be assessed daily by the Research Coordinator 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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 StepWatch™ 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.

Eligibility criteria: Inclusion Criteria:

1. Capable and appropriate for independent ambulation (with or without gait aids) as determined daily by the health care team
2. Cognitively safe for participation
3. Anticipated to remain hospitalized ≥48 hours
4. Inpatient, admitted to Internal Medicine at University Hospital
5. Age \>18 years

Exclusion Criteria:

1. Preexisting condition precludes patient from independent ambulation at time of admission
2. Active medical condition precludes patient from safely participating
3. Preexisting condition or active medical condition renders patient unfit to participate as judged by the admitting team
4. Patients who refuse to participate or are unable to provide informed consent.
5. Communication barrier (due to hearing/vision impairment, or language barrier)
6. Patients receiving treatment from an LHSC inpatient Physiotherapist.

Primary outcomes:
measure: Re-hospitalization
timeFrame: 30 days after randomization
measure: Presentation to emergency department
timeFrame: 30 days after randomization
measure: Prolonged index hospital admission
timeFrame: 30 days after randomization
Secondary outcomes:
measure: Length of stay for index hospital admission
timeFrame: 30 days after randomization
measure: Post-discharge Falls
timeFrame: 30 days after randomization
measure: Timed-Up-And-Go
timeFrame: 30 days after randomization
measure: Barthel Index
timeFrame: 30 days after randomization
measure: Frailty
timeFrame: 30 days after randomization
measure: Deconditioning
timeFrame: 30 days after randomization
measure: Increased number of steps
timeFrame: 30 days after randomization
measure: EQ-5D
timeFrame: 30 days after randomization
Other outcomes:
Locations:
city: London
country: Canada
facility: LHSC-University Hospital
state: Ontario
Study officials:
References: