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
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Coronary Heart Disease Hypertension Diabete Mellitus Dyslipidemias Obesity Heart Failure||Behavioral: Gamification Intervention||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|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|
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.
- 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).
- 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
- Hospital length of stay [ Time Frame: Average 5 days ]Length of inpatient hospital stay
- Discharge to post-acute facilities [ Time Frame: 30 days ]Discharge to post-acute facilities (skilled nursing facility or rehabilitation facility)
- 30-day acute care utilization [ Time Frame: 30 days ]30-day acute care utilization (hospital readmission or ED visits)
- 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.
- 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.
- 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
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
|Contact: Kirstin Manges, PhD||215-746-4009||Kirstin.Manges@pennmedicine.upenn.edu|
|Contact: Ryan Greysen, MD, MHS, MA|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Ryan Greysen, MD, MHS, MA||University of Pennsylvania|