Bone Marrow TransplantationNCT04474730
Physical Activity Monitoring Among BMT Patients
A study testing BMT Physical Activity app and Watch Only in people with Bone Marrow Transplantation, run by Ming-Yuan Chih at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Marrow Transplantation
- What is being tested?
- BMT Physical Activity app and Watch Only
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Design Phase: Post 100 days BMT patients, family caregivers and providers
- Trial Phase: New BMT patients
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky Markey Cancer Center
Lexington, Kentucky, 40536
About this study
Official title: 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.
Read the 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.
- Conditions
- Bone Marrow Transplantation
- Being tested
- BMT Physical Activity app, Watch Only
- Keywords
- Bone Marrow Transplantation, Mobile Health, Symptom Management, Physical Activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMT Physical Activity appDevice
This app sends reminders to patients, collect activity data from Apple Watch, and allow patients to submit symptoms.
Watch OnlyOther
A locked Apple Watch will be used to collect physical activity data from the Watch Only patients.
| Study group | Role | What they receive |
|---|---|---|
| Watch Only | Active comparator | Not described Receives: Other: Watch Only |
| Watch+App | Experimental | Not described Receives: Device: BMT Physical Activity app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - Recruitment
Recruitment rate: the percentage of eligible patients who are enrolled
Measured: The day of recruitment
Feasibility - Study completion
Study completion rate - The percentage of enrolled patients who completed the study
Measured: 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.
Measured: 30 day post transplant or at hospital discharge
Secondary outcomes (1)
Physical Activity
Steps
Measured: 30 days post intervention or at hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start1 Nov 2019
- Primary completion31 Mar 2021
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Marrow TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ming-Yuan Chih
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ming-Yuan Chih, University of Kentucky
- Investigators
- Ming-Yuan Chih, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04474730
- Sponsor's protocol ID
- 51563
- Status last verified
- Oct 2022
- First submitted
- 15 Jun 2020
- Last updated
- 31 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity Monitoring Among Bone Marrow Transplant Patients: An Apple Watch Feasibility Study
- ClinicalTrials.gov ID
- NCT04474730
- Acronym / sponsor ID
- 51563
- Conditions
- Bone Marrow Transplantation
- Keywords
- Bone Marrow Transplantation, Mobile Health, Symptom Management, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Ming-Yuan ChihUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 17 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Watch Only | Active comparator | Other: Watch Only |
| Watch+App | Experimental | Device: BMT Physical Activity app |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Design Phase: Post 100 days BMT patients, family caregivers and providers
- Trial Phase: New BMT patients
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMT Physical Activity appThis app sends reminders to patients, collect activity data from Apple Watch, and allow patients to submit symptoms. | Device | Watch+App |
| Watch OnlyA locked Apple Watch will be used to collect physical activity data from the Watch Only patients. | Other | Watch Only |
Primary outcome
Feasibility - Recruitment
Time frame: The day of recruitment
Recruitment rate: the percentage of eligible patients who are enrolled
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
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.
1 secondary outcome
Physical Activity
Time frame: 30 days post intervention or at hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming-Yuan Chih, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BMT Physical Activity app and Watch Only in people with Bone Marrow Transplantation, run by Ming-Yuan Chih at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - Recruitment (time frame: The day of recruitment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2022.