Clinical trial NCT04300764: Gamification to Increase Mobility in the Hospital
Official title: Gamification to Increase Mobility in the Hospital
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Coronary Heart Disease
Hypertension
Diabete Mellitus
Dyslipidemias
Obesity
Heart Failure
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2020-03-09
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Low mobility is a mediator for poor outcomes of hospital care. Wearable devices will be used and 2-way texting via patient smartphones to monitor patients' physical activity during hospitalization with and without gamification to improve patient adherence to existing guidance on recommended activity. After discharge, investigators will assess patient care utilization (SNF, inpatient vs home rehab, ED visits, readmission) and conduct validated surveys on patient function at 30 days after discharge.

Detailed description: Hospitalization is a common occurrence for older adults; approximately 6.8 million Medicare seniors experience an admission for acute care in any given year. This is often a sentinel event in the overall health trajectory of older adults that is complicated by functional impairment, Skilled Nursing Facility placement, and reduced mobility after discharge.

In the current paradigm, low mobility during hospitalization is largely viewed as a temporary inconvenience that should not affect overall functional ability or outcomes such nursing home placement and that patients should return to their previous activity level soon after they return home without lingering mobility changes. Recent research, however, suggests disruptions of basic activities of daily life such as mobility (getting out of bed and walking) may be "traumatic" or "toxic" to older adults with long-term post-hospital effects. What is lacked is precise data on how much immobility is noxious and how much mobility is needed to protect against adverse outcomes.

The primary objective is to assess the effectiveness of a gamification intervention to increase physical activity before hospital discharge. Investigators will explore patients' physical activity while in the hospital and if that differs across floors that have already deployed a nursing mobility protocol (Founders 10, 11, 12, 14). Investigators will also explore changes in patient functional status, SNF placement, and 30-day hospital readmission.

Eligibility criteria: Inclusion Criteria:

* Admitted to a medicine or cardiology floor in the hospital
* Age 50 years or older
* Have an AMPAC (mobility scale) score of greater than or equal to 21 or a Braden mobility sub-scale score of 4.

Exclusion Criteria:

* Inability to provide informed consent
* Does not have daily access to a smartphone compatible with the wearable device and not willing to use a device that the study team can provide
* Inpatient AMPAC score of less than 21 or a Braden mobility sub-scale score less than 4 indicating that independent physical activity may not be appropriate for the patient
* Are already enrolled in another physical activity study
* Any conditions that would prohibit participation in an inpatient physical activity program (at the discretion of attending physician or nurse caring for the patient in the hospital). To minimize the risk of contamination across study arms, we will only approach one patient per hospital room in shared rooms

Primary outcomes:
measure: Change in mean daily step count during hospitalization
timeFrame: Average 5 days
Secondary outcomes:
measure: Proportion of patients who attain pre-specified step thresholds during hospitalization and after discharge
timeFrame: Average 35 days
measure: Hospital length of stay
timeFrame: Average 5 days
measure: Discharge to post-acute facilities
timeFrame: 30 days
measure: 30-day acute care utilization
timeFrame: 30 days
measure: Change in activities of daily living
timeFrame: Average 35 days
measure: Change in difficulty with walking
timeFrame: Average 35 days
measure: Change in life space assessment
timeFrame: Average 35 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Ryan Greysen, MD, MHS, MA
role: PRINCIPAL_INVESTIGATOR
References: