- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05736484
Randomized Clinical Trial to Improve Mobility After Hospitalization (MOVE_ON)
The MOVE ON Trial: A Randomized Trial of Gamification and Coaching to Improve Mobility After Hospitalization
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ai Leen Oon, MBDS
- Phone Number: 7574471579
- Email: aileen.oon@pennmedicine.upenn.edu
Study Contact Backup
- Name: Ryan Greysen, MD, MHS, MA
- Email: ryan.greysen@pennmedicine.upenn.edu
Study Locations
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Blockley Hall
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Participants will receive a wearable device (e.g.
FitBit) but no other interventions during the intervention or follow-up periods.Participants will complete milestones within the study, such as the Function assessment during the 6, and 12-month timepoints in the study.
They will also complete a series of surveys during the 3, 6, 9, and 12-month timepoints in the study.
Participants will complete an end-of-study questionnaire on their experience with the wearable device and time in the study.
|
|
Experimental: Social Support Gamification
Intervention participants will receive a wearable device (e.g. FitBit) and will enter a game designed with behavioral economics concepts to address predictable barriers to behavior change during a 26-week intervention period. Participants will also work with a virtual health coach throughout the intervention period to increase their physical activity. At the end of the 26 week intervention period, participants will enter a 26 week follow-up period during which interventions will cease but passive data collection of step counts will continue. Participants will also complete milestones within the study, such as the Function assessment during the 6, and 12-month timepoints in the study. They will also complete a series of surveys during the 3, 6, 9, and 12-month timepoints in the study. Participants will complete an end-of-study questionnaire on their experience with the wearable device and time in the study. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in mean daily step count from baseline to the end of the 26 week intervention period.
Time Frame: Baseline to 26 week intervention period (Weeks 1-26)
|
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.
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Baseline to 26 week intervention period (Weeks 1-26)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in mean daily step count from baseline to the end of the 26 week follow-up period.
Time Frame: Baseline to 52 weeks- end of the study (Weeks 1-52)
|
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.
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Baseline to 52 weeks- end of the study (Weeks 1-52)
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Participants' mobility disability throughout the entire study (Baseline to end of study [52 weeks]).
Time Frame: Baseline to 26 and 52 weeks- end of the study (Weeks 1-52)
|
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.
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Baseline to 26 and 52 weeks- end of the study (Weeks 1-52)
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Participants' acute care utilization throughout the entire study (Baseline to end of study [52 weeks]).
Time Frame: Baseline to 26 and 52 weeks- end of the study (Weeks 1-52)
|
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.
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Baseline to 26 and 52 weeks- end of the study (Weeks 1-52)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ryan Greysen, MD, MHS, MA, University of Pennsylvania
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 852338
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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