Physical Activity Monitoring Among BMT Patients

October 28, 2022 updated by: Ming-Yuan Chih

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Markey Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility - Recruitment
Time Frame: The day of recruitment
Recruitment rate: the percentage of eligible patients who are enrolled
The day of recruitment
Feasibility - Study completion
Time Frame: From enrollment to 30 day post transplant or at hospital discharge
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
Time Frame: 30 day post transplant or at hospital discharge
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
Time Frame: 30 days post intervention or at hospital discharge
Steps
30 days post intervention or at hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ming-Yuan Chih

Investigators

  • Principal Investigator: Ming-Yuan Chih, PhD, University Of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Actual)

March 31, 2021

Study Completion (Actual)

March 31, 2022

Study Registration Dates

First Submitted

June 15, 2020

First Submitted That Met QC Criteria

July 16, 2020

First Posted (Actual)

July 17, 2020

Study Record Updates

Last Update Posted (Actual)

October 31, 2022

Last Update Submitted That Met QC Criteria

October 28, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 51563

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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