Physical Activity Monitoring Among BMT Patients

NCT04474730 | Completed FDA Device

• 1 other identifier: 51563
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bone Marrow Transplantation

Keywords

Bone Marrow Transplantation; Mobile Health; Symptom Management; Physical Activity

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Physical Activity

  30 days post intervention or at hospital discharge

Study Arms (2)

Watch Only

ACTIVE COMPARATOR

Other: Watch Only

Watch+App

EXPERIMENTAL

Device: BMT Physical Activity app

Interventions

BMT Physical Activity app DEVICE

This app sends reminders to patients, collect activity data from Apple Watch, and allow patients to submit symptoms.

Watch+App

Watch Only OTHER

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

Watch Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Design Phase: Post 100 days BMT patients, family caregivers and providers
• Trial Phase: New BMT patients

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ming-Yuan Chih: lead

Study Sites (1)

University of Kentucky Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Ming-Yuan Chih, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: July 17, 2020
• Study Start: November 1, 2019
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2022
• Last Updated: October 31, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)