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Physical Activity Monitoring Among BMT Patients

Sponsor
Ming-Yuan Chih (Other)
Overall Status
Recruiting
CT.gov ID
NCT04474730
Collaborator
(none)
21
Enrollment
1
Location
2
Arms
33
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: BMT Physical Activity app
  • Other: Watch Only
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
21 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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 (Outcomes Assessor)
Primary Purpose:
Device Feasibility
Official Title:
Physical Activity Monitoring Among Bone Marrow Transplant Patients: An Apple Watch Feasibility Study
Actual Study Start Date :
Nov 1, 2019
Actual Primary Completion Date :
Mar 31, 2021
Anticipated Study Completion Date :
Jul 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Feasibility - Recruitment [The day of recruitment]

    Recruitment rate: the percentage of eligible patients who are enrolled

  2. Feasibility - Study completion [From enrollment to 30 day post transplant or at hospital discharge]

    Study completion rate - The percentage of enrolled patients who completed the study

  3. Feasibility - Usability [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.

Secondary Outcome Measures

  1. Physical Activity [30 days post intervention or at hospital discharge]

    Steps

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Kentucky Markey Cancer Center Lexington Kentucky United States 40536

Sponsors and Collaborators

  • Ming-Yuan Chih

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ming-Yuan Chih, Assistant Professor, University of Kentucky
ClinicalTrials.gov Identifier:
NCT04474730
Other Study ID Numbers:
  • 51563
First Posted:
Jul 17, 2020
Last Update Posted:
Apr 27, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Ming-Yuan Chih, Assistant Professor, University of Kentucky
Bone Marrow Transplantation
Mobile Health
Symptom Management
Physical Activity

Study Results

No Results Posted as of Apr 27, 2021