Randomized Clinical Trial to Improve Mobility After Hospitalization

NCT05736484 | Active Not Recruiting DMC

• 1 other identifier: 852338
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Gamification; Physical Activity; Behavioral Economics; Social Support; Mobility

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in mean daily step count from baseline to the end of the 26 week follow-up period.

  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]).

  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]).

  Baseline to 26 and 52 weeks- end of the study (Weeks 1-52)

Study Arms (2)

Control

NO INTERVENTION

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.

Social Support Gamification

EXPERIMENTAL

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

Interventions

Social Support Gamification 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.

Social Support Gamification

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Blockley Hall

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus; Heart Failure; Mobility Limitation; Motor Activity

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Heart Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Ryan Greysen, MD, MHS, MA

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 21, 2023
• Study Start: September 19, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Locations

US (1)