Remote patient Monitoring in adults receiving red blood cell Transfusion for hematological disorders * a Pilot study of the physIQ Real World Monitoring platform using wearable biosensors

Completed

• Conditions: chronic anemia; myelodysplastic syndrome; 10038158

• Registration Number: NL-OMON50160
• Lead Sponsor: HagaZiekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

18 years old or above
in need of at least 1 red blood cell transfusion each month

Exclusion Criteria

Cardiological conductivity disorder
Severe pulmonary comorbidities
Known skin allergies
Participating in another clinical study

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Processed data sets collected from continuous monitoring with the VitalPatch<br /><br>including, but not limited to: heart rate; respiratory rate and activity.<br /><br>- A significant difference in mean heartrate per day before and after<br /><br>transfusion, large enough in comparison to the standard deviation of the mean<br /><br>to power a study with a reasonable sample size (<150pt).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Processed data sets collected from continuous monitoring with the Withings<br /><br>steel HR including, but not limited to: heart rate; respiratory rate and<br /><br>activity.<br /><br>- PROMIS SF Questionnaire<br /><br>- QUALMS Questionnaire<br /><br>- CANTAB RVP Cognitive tool<br /><br>- Amount of RBC units transfused</p><br>