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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04300764
Other study ID # 834466
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 1, 2026
Est. completion date December 31, 2026

Study information

Verified date September 2023
Source University of Pennsylvania
Contact Kirstin Manges, PhD
Phone 215-746-4009
Email Kirstin.Manges@pennmedicine.upenn.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 150
Est. completion date December 31, 2026
Est. primary completion date April 30, 2026
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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

Study Design


Intervention

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.

Locations

Country Name City State
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 Average 35 days
Secondary Hospital length of stay Length of inpatient hospital stay Average 5 days
Secondary Discharge to post-acute facilities Discharge to post-acute facilities (skilled nursing facility or rehabilitation facility) 30 days
Secondary 30-day acute care utilization 30-day acute care utilization (hospital readmission or ED visits) 30 days
Secondary 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. Average 35 days
Secondary 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. Average 35 days
Secondary 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 Average 35 days
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