NCT04300764

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
8mo left

Started Jan 2026

Shorter than P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress35%
Jan 2026Dec 2026

First Submitted

Initial submission to the registry

February 22, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 9, 2020

Completed
5.8 years until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

4 months

First QC Date

February 22, 2020

Last Update Submit

December 22, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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).

    Average 5 days

Secondary Outcomes (7)

  • Proportion of patients who attain pre-specified step thresholds during hospitalization and after discharge

    Average 35 days

  • Hospital length of stay

    Average 5 days

  • Discharge to post-acute facilities

    30 days

  • 30-day acute care utilization

    30 days

  • Change in activities of daily living

    Average 35 days

  • +2 more secondary outcomes

Study Arms (2)

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.

Behavioral: Gamification Intervention

Interventions

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.

Gamification Intervention

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Coronary Artery DiseaseCoronary DiseaseHypertensionDiabetes MellitusDyslipidemiasObesityHeart Failure

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesLipid Metabolism DisordersOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ryan Greysen, MD, MHS, MA

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ryan Greysen, MD, MHS, MA

Study Record Dates

First Submitted

February 22, 2020

First Posted

March 9, 2020

Study Start

January 1, 2026

Primary Completion

April 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

December 30, 2025

Record last verified: 2025-12

Locations