search
Back to results

Gamification to Increase Mobility in the Hospital (Level Up)

Primary Purpose

Coronary Artery Disease, Coronary Heart Disease, Hypertension

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gamification Intervention
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Coronary Artery Disease

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Gamification Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in mean daily step count during hospitalization
The primary outcome variable is the change in mean daily step count during hospitalization (from enrollment to discharge).

Secondary Outcome Measures

Proportion of patients who attain pre-specified step thresholds during hospitalization and after discharge
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
Length of inpatient hospital stay
Discharge to post-acute facilities
Discharge to post-acute facilities (skilled nursing facility or rehabilitation facility)
30-day acute care utilization
30-day acute care utilization (hospital readmission or ED visits)
Change in activities of daily living
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
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
Change in functional status measure of life space assessment from admission to 30 days post-discharge.using the Life Space Activity Survey

Full Information

First Posted
February 22, 2020
Last Updated
September 18, 2023
Sponsor
University of Pennsylvania
search

1. Study Identification

Unique Protocol Identification Number
NCT04300764
Brief Title
Gamification to Increase Mobility in the Hospital
Acronym
Level Up
Official Title
Gamification to Increase Mobility in the Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2026 (Anticipated)
Primary Completion Date
April 30, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Coronary Heart Disease, Hypertension, Diabete Mellitus, Dyslipidemias, Obesity, Heart Failure

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Gamification Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Gamification Intervention
Intervention Description
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 Measure Information:
Title
Change in mean daily step count during hospitalization
Description
The primary outcome variable is the change in mean daily step count during hospitalization (from enrollment to discharge).
Time Frame
Average 5 days
Secondary Outcome Measure Information:
Title
Proportion of patients who attain pre-specified step thresholds during hospitalization and after discharge
Description
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
Time Frame
Average 35 days
Title
Hospital length of stay
Description
Length of inpatient hospital stay
Time Frame
Average 5 days
Title
Discharge to post-acute facilities
Description
Discharge to post-acute facilities (skilled nursing facility or rehabilitation facility)
Time Frame
30 days
Title
30-day acute care utilization
Description
30-day acute care utilization (hospital readmission or ED visits)
Time Frame
30 days
Title
Change in activities of daily living
Description
Change in functional status measure of activities of daily living from admission to 30 days post-discharge.using the Activities of Daily Living Scale.
Time Frame
Average 35 days
Title
Change in difficulty with walking
Description
Change in functional status measure of difficulty with walking from admission to 30 days post-discharge using the Activities of Daily Living Scale.
Time Frame
Average 35 days
Title
Change in life space assessment
Description
Change in functional status measure of life space assessment from admission to 30 days post-discharge.using the Life Space Activity Survey
Time Frame
Average 35 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kirstin Manges, PhD
Phone
215-746-4009
Email
Kirstin.Manges@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ryan Greysen, MD, MHS, MA
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Greysen, MD, MHS, MA
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Gamification to Increase Mobility in the Hospital

We'll reach out to this number within 24 hrs