- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04300764
Gamification to Increase Mobility in the Hospital (Level Up)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
Participants will be recruited during an inpatient stay and given a Fitbit watch that will transmit data to the Way to Health study platform.
Control participants' steps will be passively monitored.
Data will continue to be collected for 30 days after discharge.
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|
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Experimental: Gamification Intervention
Participants will be recruited during an inpatient stay and given a Fitbit watch that will transmit data to the Way to Health study platform.
Intervention patients will receive daily text messages to help them set goals, receive feedback and support on their progress towards daily goals, and receive points for daily goals achieved.
Data will continue to be collected for 30 days after discharge.
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Intervention participants will receive daily text messages to help them set goals, receive feedback and support on their progress towards daily goals, and receive points for daily goals achieved.
Each participant will be given a Fitbit watch that will transmit data to the Way to Health study platform.
Data will be passively collected during the inpatient stay and for 30 days after hospital discharge.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in mean daily step count during hospitalization
Time Frame: Average 5 days
|
The primary outcome variable is the change in mean daily step count during hospitalization (from enrollment to discharge).
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Average 5 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of patients who attain pre-specified step thresholds during hospitalization and after discharge
Time Frame: Average 35 days
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Proportion of patients in each group who attain pre-specified step thresholds of 1000, 2000, 3000 during hospitalization and 3500, 4000, 4500, and 5000 after discharge
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Average 35 days
|
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Hospital length of stay
Time Frame: Average 5 days
|
Length of inpatient hospital stay
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Average 5 days
|
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Discharge to post-acute facilities
Time Frame: 30 days
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Discharge to post-acute facilities (skilled nursing facility or rehabilitation facility)
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30 days
|
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30-day acute care utilization
Time Frame: 30 days
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30-day acute care utilization (hospital readmission or ED visits)
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30 days
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Change in activities of daily living
Time Frame: Average 35 days
|
Change in functional status measure of activities of daily living from admission to 30 days post-discharge.using
the Activities of Daily Living Scale.
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Average 35 days
|
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Change in difficulty with walking
Time Frame: Average 35 days
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Change in functional status measure of difficulty with walking from admission to 30 days post-discharge using the Activities of Daily Living Scale.
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Average 35 days
|
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Change in life space assessment
Time Frame: Average 35 days
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Change in functional status measure of life space assessment from admission to 30 days post-discharge.using
the Life Space Activity Survey
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Average 35 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ryan Greysen, MD, MHS, MA, University of Pennsylvania
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Nutrition Disorders
- Heart Diseases
- Metabolic Diseases
- Overnutrition
- Body Weight
- Glucose Metabolism Disorders
- Overweight
- Lipid Metabolism Disorders
- Arteriosclerosis
- Arterial Occlusive Diseases
- Myocardial Ischemia
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Heart Failure
- Obesity
- Hypertension
- Diabetes Mellitus
- Coronary Artery Disease
- Dyslipidemias
- Coronary Disease
Other Study ID Numbers
- 834466
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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