Physical Activity Monitoring Among BMT Patients

Bone Marrow Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04474730
• Other study ID #: 51563
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: March 31, 2022

Study information

• Verified date: October 2022
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Marrow Transplantation

Intervention

Device:
• BMT Physical Activity app
This app sends reminders to patients, collect activity data from Apple Watch, and allow patients to submit symptoms.

Other:
• Watch Only
A locked Apple Watch will be used to collect physical activity data from the Watch Only patients.

Locations

Country	Name	City	State
United States	University of Kentucky Markey Cancer Center	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Ming-Yuan Chih

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility - Recruitment	Recruitment rate: the percentage of eligible patients who are enrolled	The day of recruitment
Primary	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
Primary	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	Physical Activity	Steps	30 days post intervention or at hospital discharge