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Randomized Clinical Trial to Improve Mobility After Hospitalization (MOVE_ON)

Primary Purpose

Hypertension, Diabetes, Heart Failure

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social Support Gamification
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypertension focused on measuring Gamification, Physical Activity, Behavioral Economics, Social Support, Mobility

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Blockley Hall

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Social Support Gamification

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
February 6, 2023
Last Updated
September 20, 2023
Sponsor
University of Pennsylvania
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT05736484
Brief Title
Randomized Clinical Trial to Improve Mobility After Hospitalization
Acronym
MOVE_ON
Official Title
The MOVE ON Trial: A Randomized Trial of Gamification and Coaching to Improve Mobility After Hospitalization
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 19, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Diabetes, Heart Failure, Ambulatory Difficulty, Mobility Limitation
Keywords
Gamification, Physical Activity, Behavioral Economics, Social Support, Mobility

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Social Support Gamification
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Social Support Gamification
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in mean daily step count from baseline to the end of the 26 week intervention period.
Description
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.
Time Frame
Baseline to 26 week intervention period (Weeks 1-26)
Secondary Outcome Measure Information:
Title
Change in mean daily step count from baseline to the end of the 26 week follow-up period.
Description
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.
Time Frame
Baseline to 52 weeks- end of the study (Weeks 1-52)
Title
Participants' mobility disability throughout the entire study (Baseline to end of study [52 weeks]).
Description
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.
Time Frame
Baseline to 26 and 52 weeks- end of the study (Weeks 1-52)
Title
Participants' acute care utilization throughout the entire study (Baseline to end of study [52 weeks]).
Description
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.
Time Frame
Baseline to 26 and 52 weeks- end of the study (Weeks 1-52)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Greysen, MD, MHS, MA
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Blockley Hall
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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Randomized Clinical Trial to Improve Mobility After Hospitalization

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