Randomized Clinical Trial to Improve Mobility After Hospitalization

Hypertension Clinical Trial

— MOVE_ON  

Official title:

The MOVE ON Trial: A Randomized Trial of Gamification and Coaching to Improve Mobility After Hospitalization

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05736484
• Other study ID #: 852338
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 19, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to test the feasibility of using behavioral economic interventions (gamification with social incentives) to increase physical activity after hospital discharge to reduce incident mobility disability among older adults.

Description:

MOVE ON is a 2-arm, randomized trial enrolling older adults 50 years or older with a recent hospitalization for hypertension, diabetes, and mild-moderate heart failure. The 52 week trial compares a control group wearing a wearable activity tracker to the intervention group that uses the same device and receives a supportive social incentive-based gamification intervention. The primary goal is to increase physical activity after discharge from the hospital to reduce incident mobility disability associated with acute illness and to reduce acute and post-acute care utilization.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Age 50 years or older
• Admitted to the University of Pennsylvania Health System acute care hospital (Hospital of the University of Pennsylvania, Penn Presbyterian Medical Center, Pennsylvania Hospital, Lancaster General Health, Chester County Hospital, or Penn Medicine Princeton Medical Center) and discharged to home
• Able to ambulate independently

Exclusion Criteria:

• Inability to provide informed consent
• Does not have daily access to a smartphone compatible with the wearable device and is not willing to use a device that the investigators can provide participants' with
• Already enrolled in another physical activity study
• Low mobility score indicating that the patient is not able to walk distances greater than 1000 steps/day independently
• Any other medical conditions that would prohibit participation in a 6-month physical activity program
• Unable to complete the baseline period (must have at least 4 out of 7 days of step data with minimum step count of 1000 steps/day)
• Not willing to use the wearable device for the full duration of the study
• Enrolled in hospice

Related Conditions & MeSH terms

• Ambulatory Difficulty
• Diabetes
• Heart Failure
• Hypertension
• Mobility Limitation

Intervention

Behavioral:
• Social Support Gamification
Participants sign a pre-commitment contract agreeing to try their best to achieve their daily step goal. Over the 26-week intervention period, participants are endowed 70 points (10/day) weekly and informed they will lose 10 points each day goal is not met. Points are replenished at start of each week. At the end of each week, if the participant has 40 points or more, they will advance a level, or drop a level if they have less than 40 points. The levels include blue (lowest), bronze, silver, gold, platinum (highest). Participants select a family member or friend as a support partner to receive weekly email on participants' progress (points, game level, and average step count). Participants will also work with a virtual health coach by attending group sessions organized by them with other participants through video calls once a month to discuss ways to motivate participants to increase their physical activity.

Locations

Country	Name	City	State
United States	Blockley Hall	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean daily step count from baseline to the end of the 26 week intervention period.	The primary outcome of the study is the participants' change in mean daily steps from the baseline period to the end of the 26 week intervention period collected by Fitbit Inspire device.	Baseline to 26 week intervention period (Weeks 1-26)
Secondary	Change in mean daily step count from baseline to the end of the 26 week follow-up period.	The secondary outcome will examine the change in participants' mean daily step counts from the baseline period to the end of the 26 week follow-up period after the end of the 26 week intervention period collected by the Fitbit device.	Baseline to 52 weeks- end of the study (Weeks 1-52)
Secondary	Participants' mobility disability throughout the entire study (Baseline to end of study [52 weeks]).	The investigators will explore participant mobility disability; defined as the change in the Patient-Reported Outcomes Measurement Information System (PROMIS) mobility measure score (on a scale of 5- without any difficulty to 1- unable to do) from baseline to 26 and 52 weeks, adjusting for time and participant baseline characteristics.	Baseline to 26 and 52 weeks- end of the study (Weeks 1-52)
Secondary	Participants' acute care utilization throughout the entire study (Baseline to end of study [52 weeks]).	The investigators will explore participants' acute care utilization; defined as the number of emergency department visits and hospitalizations that occur at 26 and 52 weeks, adjusting for time and participant baseline characteristics.	Baseline to 26 and 52 weeks- end of the study (Weeks 1-52)