Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04600609
Status:
RECRUITING
Last Update Posted:
2024-01-26
First Post:
2020-09-22
Brief Title:
Examining the Experiences of Children With Blood Disorders
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Examining the Experiences of Children With Blood Disorders
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a 3-phase mixed methods study design A literature review Phase 1 has been completed to determine the areas of exploration and to identify challenges faced and the impact of the blood disorder on pediatric patients Based on Phase 1 Phases 2 and 3 as proposed in this study will be completed and will include interviews of patients diagnosed with bleeding and thrombotic disorders phase 2 The interviews will be individual semi-structured and consist of open-ended questions to elicit unbiased and in-depth responses to gain an understanding of participants perspectives on themes predetermined in the study design phase
Detailed Description:
The purpose of this study is to explore the experiences of pediatric patients with blood disorders specifically thrombotic including venous thromboembolism VTE and hemostatic or bleeding disorders The information gleaned from this study will help identify specific challenges faced by patients with hemostatic and thrombotic disorders - information that is necessary to develop impactful evidence-based solutions to support patients with hemostatic and thrombotic disorders cope with the physical emotional and psychological impact of blood disorders Participants with blood disorders in this study will participate in open-ended semi-structured interviews with a study investigator focusing on the psychosocial experiences of patients with diagnosis and treatment of their underlying disorder and the understanding of their diagnosis Female participants additionally will be asked questions about the unique effects of heavy menstrual bleeding either from their underlying blood disorder or secondary to anticoagulation on similar aspects of the impact of having a blood disorder Validated questionnaires will be completed to obtain concurrent quantitative data The interviews will be recorded and transcribed Participation is complete after the interview has finished participants will continue to receive standard of care treatment during and beyond the study period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None