Physical Activity Monitoring Among BMT Patients

Study Overview
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Brief Summary
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This study aims to evaluate the feasibility of an apple watch-based application to promote physical activity among bone marrow transplant (BMT) patients.

Detailed Description
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The research objective is to test the feasibility of using an Apple Watch-based system with the capacity to monitor BMT patients' physical activity and other patient reported outcomes at an ongoing basis within the inpatient BMT setting at the University of Kentucky Markey Cancer Center (UKMCC). The central hypothesis in this project is that the Apple Watch-based system designed based on user-centered design principles and the proposed study method will yield high feasibility.

Official Title
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Physical Activity Monitoring Among Bone Marrow Transplant Patients: An Apple Watch Feasibility Study

Conditions
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Bone Marrow Transplantation

Intervention / Treatment
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* Device: BMT Physical Activity app
* Other: Watch Only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Design Phase: Post 100 days BMT patients, family caregivers and providers Trial Phase: New BMT patients Exclusion Criteria: under 18 years old; can't communicate, read or write in English; having any communicable infection or showing the signs of it, including coughing, fever, or rash; and incapable of completing the assigned research activities.

Ages Eligible for Study
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Minimum Age: 18 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: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: In this study, we conduct a small randomized controlled trial to study the feasibility of an Apple Watch app developed to monitor bone marrow transplant patients' physical activities at their initial hospitalization.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Watch Only<br> | Other: Watch Only<br>* A locked Apple Watch will be used to collect physical activity data from the Watch Only patients.<br>|
| Experimental: Watch+App<br> | Device: BMT Physical Activity app<br>* This app sends reminders to patients, collect activity data from Apple Watch, and allow patients to submit symptoms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility - Recruitment | Recruitment rate: the percentage of eligible patients who are enrolled | The day of recruitment | 
| Feasibility - Study completion | Study completion rate - The percentage of enrolled patients who completed the study | From enrollment to 30 day post transplant or at hospital discharge | 
| Feasibility - Usability | A survey scale (User version - Mobile Application Rating Scale or uMARS) will be used to measure usability. uMARS scale score is calculated by averaging the likert scale answers, which range from 0 to 5. The uMARS score of 3.5 or higher is deemed to be acceptable usability. | 30 day post transplant or at hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity | Steps | 30 days post intervention or at hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Symptom Management, Bone Marrow Transplantation, Mobile Health, Physical Activity