Randomized Clinical Trial to Improve Mobility After Hospitalization

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hypertension, Diabetes, Heart Failure, Ambulatory Difficulty, Mobility Limitation

Intervention / Treatment
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* Behavioral: Social Support Gamification


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a 2-arm randomized control trial over 26 weeks with 26 weeks follow-up (total of 52 weeks) that 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>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<br>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. | Behavioral: Social Support Gamification<br>* 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.<br>|

What is the study measuring?
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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. | 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 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. | 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gamification, Physical Activity, Behavioral Economics, Social Support, Mobility