## Protocol Section
### Identification Module
**NCT ID:** NCT03321279

**Acronym:** MOVE IT

**Brief Title:** Social Incentives to Increase Mobility

**Official Title:** Social Incentives to Increase Mobility Among Hospitalized Patients: The MOVE IT Randomized Trial

#### Organization Study ID Info
**ID:** 826974
#### Organization
**Class:** OTHER
**Full Name:** University of Pennsylvania
### Status Module
#### Completion Date
**Date:** 2019-09-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-07-30

**Type:** ACTUAL

**Last Update Submit Date:** 2020-07-29

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-09-09

**Type:** ACTUAL

#### Start Date
**Date:** 2018-01-11

**Type:** ACTUAL

**Status Verified Date:** 2020-07

#### Study First Post Date
**Date:** 2017-10-25
**Type:** ACTUAL
**Study First Submit Date:** 2017-10-04
**Study First Submit QC Date:** 2017-10-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Pennsylvania

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study aims to assess the effectiveness of a social incentive-based gamification intervention to increase physical activity in the 3 months after hospital discharge.

**Detailed Description:** This study aims to assess the effectiveness of a social incentive-based gamification intervention to increase physical activity in the 3 months after hospital discharge. To do this, the investigators will conduct a two-arm randomized, controlled trial during the 3-months after hospital discharge comparing a control group that uses a wearable device to track physical activity to an intervention group that uses the same wearable devices and receives a supportive social incentive-based gamification intervention to adhere to a step goal program. Patients will be enrolled during hospitalization from medicine and oncology floors into three phases. In phase 1 (hospitalization), patients inpatient step counts will be monitored. In phase 2 (week 1 post-discharge), patients will have a baseline step count estimated. In phase 3 (weeks 2-13 post-discharge), patients will be randomly assigned to the control or intervention group. Patients will be considered enrolled in the trial if they complete the run-in periods (phases 1 and 2) and then are randomized into phase 3.

The enrollment phase will be part of another randomized trial which evaluates the impact of three recruitment strategies on patient enrollment. This trial will be completed and unmasked to patients before they begin the phase 1 of our study.

The investigators will also explore patients' physical activity while in the hospital and if that differs across floors that have or have not deployed a nursing mobility protocol. Changes in patient functional decline and 30-day hospital readmission will also be explored.

### Conditions Module

**Conditions:**

- Pneumonia

- Diabetes

- Congestive Heart Failure

- Chronic Obstructive Pulmonary Disease

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 233

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants' daily step counts will be for weeks 2-13 after hospital discharge. Participants will be asked to complete surveys at 5, 9 and 13 weeks post-discharge.

**Label:** Control

**Type:** NO_INTERVENTION

#### Arm Group 2

**Description:** Participants' daily step counts will be monitored for weeks 2-13 after hospital discharge. Participants will have a weekly step goal that increases from baseline by 10% each week of the intervention (12 weeks). Participants will engage in a social incentive-based gamification based on points and levels that leverages loss aversion, which has been demonstrated to motivate behavior change more effectively with losses than gains. Participants will receive daily feedback for the step counts and weekly feedback for levels. Participants will be asked to identify a support partner, who will receive weekly reports with the the participant's points and levels balance.

**Intervention Names:**

- Behavioral: Social Incentive

**Label:** Intervention

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention

**Description:** Participants in the intervention arm will receive social incentives as part of the intervention. See arm descriptions for more detail.

**Name:** Social Incentive

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** The primary outcome variable is the change in mean daily step count from the baseline period (week 1 post-discharge) to the intervention period (weeks 2-13 post-discharge). This will be measured using the Nokia Steel wearable device. .

**Measure:** Change in mean daily step count from the baseline period to the intervention period, using a wearable pedometer (Nokia Steel) to measure step count.

**Time Frame:** 13 weeks

#### Secondary Outcomes

**Description:** A secondary outcome variable is 30-day hospital readmission post-discharge, which will be obtained from the state-based registry.

**Measure:** 30-day hospital readmission post-discharge, using the state's hospital database

**Time Frame:** 13 weeks

**Description:** A secondary outcome variable is functional decline from admission to 3 months post-discharge, which will be obtained from information collected through validated survey assessments.

**Measure:** Functional decline from admission to 3 months post-discharge, measured using validated survey assessments.

**Time Frame:** 13 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age 18 or older
* Admitted to medicine or oncology floor in the hospital

Exclusion Criteria:

* Inability to provide informed consent
* Does not have daily access to a smartphone compatible with the wearable device
* Already enrolled in another physical activity program
* Inpatient mobility score of 0 or 1 indicating that physical activity is not appropriate for the patient
* Any other medical conditions that would prohibit participation in a 3-month physical activity program
* Unable to complete the run-in phases (e.g. not discharged from the hospital within 60 days of enrolling; not willing to use the wearable device for the 3-month post-discharge intervention).

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Philadelphia

**Country:** United States

**Facility:** University of Pennsylvania

**State:** Pennsylvania

**Zip:** 19104

#### Overall Officials

**Official 1:**

**Affiliation:** University of Pennsylvania

**Name:** Ryan Greysen, MD, MHS, MA

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** University of Pennsylvania

**Name:** Mitesh Patel, MD, MBA, MS

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** Greysen SR, Waddell KJ, Patel MS. Exploring Wearables to Focus on the "Sweet Spot" of Physical Activity and Sleep After Hospitalization: Secondary Analysis. JMIR Mhealth Uhealth. 2022 Apr 27;10(4):e30089. doi: 10.2196/30089.

**PMID:** 35476034

**Citation:** Greysen SR, Changolkar S, Small DS, Reale C, Rareshide CAL, Mercede A, Snider CK, Greysen HM, Trotta R, Halpern SD, Patel MS. Effect of Behaviorally Designed Gamification With a Social Support Partner to Increase Mobility After Hospital Discharge: A Randomized Clinical Trial. JAMA Netw Open. 2021 Mar 1;4(3):e210952. doi: 10.1001/jamanetworkopen.2021.0952.

**PMID:** 33760089

**Citation:** Greysen HM, Reale C, Mercede A, Patel MS, Small D, Snider C, Rareshide C, Halpern SD, Greysen SR. Mobility and outcomes for validated evidence - Incentive trial (MOVE IT): Randomized clinical trial study protocol. Contemp Clin Trials. 2020 Feb;89:105911. doi: 10.1016/j.cct.2019.105911. Epub 2019 Dec 12. No abstract available.

**PMID:** 31838257

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC01

- Name: Infections

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9421

- Name: Heart Failure

- Relevance: HIGH

- As Found: Congestive Heart Failure

- ID: M13904

- Name: Pneumonia

- Relevance: LOW

- As Found: Unknown

- ID: M11170

- Name: Lung Diseases, Obstructive

- Relevance: HIGH

- As Found: Obstructive Pulmonary Disease

- ID: M23449

- Name: Pulmonary Disease, Chronic Obstructive

- Relevance: HIGH

- As Found: Chronic Obstructive Pulmonary Disease

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008173

- Term: Lung Diseases, Obstructive

- ID: D000029424

- Term: Pulmonary Disease, Chronic Obstructive

- ID: D000006333

- Term: Heart Failure

### Misc Info Module

- Version Holder: 2024-05-24
