Measuring Physical Activity in Transfusion Dependent Patients With Myelodysplastic Syndrome (MDS)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myelodysplastic Syndromes
- Sponsor
- Thomas Jefferson University
- Locations
- 1
- Primary Endpoint
- Acceptability
- Status
- Withdrawn
- Last Updated
- last year
Overview
Brief Summary
This study assesses feasibility and patient acceptability of using a Fitbit to monitor step count and heart rate in transfusion dependent patients with myelodysplastic syndrome. Information from this study may help researchers understand if there is any correlation between activity level and anemia.
Detailed Description
This study assesses feasibility and patient acceptability of using a Fitbit to monitor step count and heart rate in transfusion dependent patients with myelodysplastic syndrome. Information from this study may help researchers understand if there is any correlation between activity level and anemia.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Confirmed pathologic diagnosis of MDS
- •Requiring \>= 2 blood transfusions in the past month if previously diagnosed or hemoglobin =\< 8 g/dL if newly diagnosed
- •Age \>= 18
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- •Ambulatory (use of a walking aid, such as a cane or rollator, is acceptable)
- •Able to give informed consent
- •Willing to comply with all study procedures and available for the duration of the study
- •Able to read and/or understand English
- •Have access to an iPhone 4S or later, iPad 3 generation or later, Android 5.0 or later, or Windows 10 device
- •Have access to Bluetooth low energy (LE) and internet connection for syncing
Exclusion Criteria
- •Uncontrolled illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Outcomes
Primary Outcomes
Acceptability
Time Frame: Up to 90 days
Acceptability will be measured by an interview addressing participant satisfaction
Accrual rate
Time Frame: Up to 90 days
accrual rate will be measured by counting subjects
retention rate
Time Frame: Up to 90 days
retention rate of subjects will be measured by counting at 90 days
compliance with device
Time Frame: Up to 90 days
compliance with device (80% of the 90-day intervention time)
Secondary Outcomes
- Daily step count(Up to 90 days)
- Fact-An score (assessed twice a week),(Up to 90 days)
- Average daily resting heart rate(Up to 90 days)
- Hemoglobin level measured by CBC twice a week(Up to 90 days)