Randomized Clinical Trial to Improve Mobility After Hospitalization

NCT ID: NCT05736484

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-19
• Study Completion Date: 2025-12-31

Brief 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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Social Support Gamification

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ryan Greysen, MD, MHS, MA

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Blockley Hall

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

852338

Identifier Type: -

Identifier Source: org_study_id