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Gamification to Increase Mobility in the Hospital (Level Up)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04300764
Recruitment Status : Not yet recruiting
First Posted : March 9, 2020
Last Update Posted : April 1, 2020
Sponsor:
Information provided by (Responsible Party):
Ryan Greysen, University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Coronary Heart Disease Hypertension Diabete Mellitus Dyslipidemias Obesity Heart Failure Behavioral: Gamification Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Gamification to Increase Mobility in the Hospital
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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.
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.
Behavioral: Gamification Intervention
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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Proportion of patients who attain pre-specified step thresholds during hospitalization and after discharge [ Time Frame: Average 35 days ]
    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

  2. Hospital length of stay [ Time Frame: Average 5 days ]
    Length of inpatient hospital stay

  3. Discharge to post-acute facilities [ Time Frame: 30 days ]
    Discharge to post-acute facilities (skilled nursing facility or rehabilitation facility)

  4. 30-day acute care utilization [ Time Frame: 30 days ]
    30-day acute care utilization (hospital readmission or ED visits)

  5. 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.

  6. Change in difficulty with walking [ Time Frame: Average 35 days ]
    Change in functional status measure of difficulty with walking from admission to 30 days post-discharge using the Activities of Daily Living Scale.

  7. Change in life space assessment [ Time Frame: Average 35 days ]
    Change in functional status measure of life space assessment from admission to 30 days post-discharge.using the Life Space Activity Survey



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04300764


Contacts
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Contact: Kirstin Manges, PhD 215-746-4009 Kirstin.Manges@pennmedicine.upenn.edu
Contact: Ryan Greysen, MD, MHS, MA

Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Ryan Greysen, MD, MHS, MA University of Pennsylvania

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Responsible Party: Ryan Greysen, Ryan Greysen, MD, MHS, MA, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04300764    
Other Study ID Numbers: 834466
First Posted: March 9, 2020    Key Record Dates
Last Update Posted: April 1, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Dyslipidemias
Diabetes Mellitus
Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Glucose Metabolism Disorders
Endocrine System Diseases