Myelodysplastic Syndromes
Conditions
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.
Interventions
OTHERMedical Device Usage and Evaluation
Wear activity monitor (Fitbit)
PROCEDUREBiospecimen Collection
Undergo collection of blood samples
OTHERQuestionnaire Administration
Complete questionnaires
OTHERQuality-of-Life Assessment
Complete questionnaires
Sponsors
Thomas Jefferson University
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| retention rate | Up to 90 days | retention rate of subjects will be measured by counting at 90 days |
| Accrual rate | Up to 90 days | accrual rate will be measured by counting subjects |
| Acceptability | Up to 90 days | Acceptability will be measured by a short survey |
| compliance with device | Up to 90 days | compliance with device (80% of the 90-day intervention time) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daily step count | Up to 90 days | Daily step count |
| Average daily resting heart rate | Up to 90 days | average daily resting heart rate |
| Fact-An score (assessed twice a week), | Up to 90 days | Fact-An score (assessed twice a week), |
| Hemoglobin level measured by CBC twice a week | Up to 90 days | Hemoglobin level measured by CBC twice a week |
Countries
United States
Outcome results
None listed