Coronary Artery DiseaseLevel UpNCT04300764
Gamification to Increase Mobility in the Hospital
A study testing Gamification Intervention in people with Coronary Artery Disease and Coronary Heart Disease, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Heart Disease, Hypertension
- What is being tested?
- Gamification Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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.
Read the 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.
- Conditions
- Coronary Artery Disease, Coronary Heart Disease, Hypertension, Diabete Mellitus, Dyslipidemias, Obesity
- Being tested
- Gamification Intervention
- Medical subject headings
- Coronary Artery Disease, Coronary Disease, Hypertension, Diabetes Mellitus, Dyslipidemias, Obesity, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamification InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No 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. Control participants' steps will be passively monitored. Data will continue to be collected for 30 days after discharge. |
| Gamification Intervention | Experimental | 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. Receives: Behavioral: Gamification Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Average 5 days
Secondary outcomes (7)
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
Measured: Average 35 days
Hospital length of stay
Length of inpatient hospital stay
Measured: Average 5 days
Discharge to post-acute facilities
Discharge to post-acute facilities (skilled nursing facility or rehabilitation facility)
Measured: 30 days
30-day acute care utilization
30-day acute care utilization (hospital readmission or ED visits)
Measured: 30 days
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.
Measured: Average 35 days
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.
Measured: Average 35 days
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
Measured: Average 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start1 Jan 2026 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Why it stopped: Trial was never launched due to COVID19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan Greysen, University of Pennsylvania
- Investigators
- Ryan Greysen, MD, MHS, MA, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04300764
- Sponsor's protocol ID
- 834466
- Acronym
- Level Up
- Status last verified
- Dec 2025
- First submitted
- 22 Feb 2020
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gamification to Increase Mobility in the Hospital
- ClinicalTrials.gov ID
- NCT04300764
- Acronym / sponsor ID
- Level Up / 834466
- Conditions
- Coronary Artery Disease, Coronary Heart Disease, Hypertension, Diabete Mellitus, Dyslipidemias, Obesity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Trial was never launched due to COVID19 pandemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No 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. Control participants' steps will be passively monitored. Data will continue to be collected for 30 days after discharge. |
| Gamification Intervention | Experimental | Behavioral: Gamification InterventionParticipants 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gamification InterventionIntervention 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. | Behavioural | Gamification Intervention |
Primary outcome
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).
7 secondary outcomes
Proportion of patients who attain pre-specified step thresholds during hospitalization and after discharge
Time frame: Average 35 days
Hospital length of stay
Time frame: Average 5 days
Discharge to post-acute facilities
Time frame: 30 days
30-day acute care utilization
Time frame: 30 days
Change in activities of daily living
Time frame: Average 35 days
Change in difficulty with walking
Time frame: Average 35 days
Change in life space assessment
Time frame: Average 35 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Greysen, MD, MHS, MA principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gamification Intervention in people with Coronary Artery Disease and Coronary Heart Disease, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean daily step count during hospitalization (time frame: Average 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.