Bleeding Disorder, Blood Disease, Hemostatic Disorder, Thrombotic Disorder, Venous Thromboembolism
Conditions
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 participant's 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.
Interventions
None listed
Sponsors
University of Texas Southwestern Medical Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* Patients will be eligible to participate if they are between the ages of 12 and 21 years of age, English speaking and have a formal diagnosis of a hemostatic or thrombotic disorder. For thrombotic disorder patients, an additional eligibility criterion will be to include participants within 1 year of diagnosis.
Exclusion criteria
* Patients will be excluded if they do not have access to the technology needed to participate in a virtual interview visit (by telephone).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life assessment | Within 1 year of diagnosis for clot patients; after formal diagnosis for bleeding disorder patients | Effect of blood disorder diagnosis on quality of life will be measured using Pediatric Quality of Life Questionnaire, Menorrhagia Impact Questionnaire, and Godin Physical Activity Questionnaire |
| Patient confidence assessment | Within 1 year of diagnosis for clot patients; after formal diagnosis for bleeding disorder patients | Patient confidence in managing blood disorder and recognizing emergencies will be assessed using a semi-structured interview with the patient |
| Quality of care assessment | Within 1 year of diagnosis for clot patients; after formal diagnosis for bleeding disorder patients | Impressions of quality of care received in a specialized bleeding disorders and thrombosis clinic will be assessed using a semi-structured interview with the patient |
| Implications on the future for the patient with the bleeding disorder | Within 1 year of diagnosis for clot patients; after formal diagnosis for bleeding disorder patients | Patient's reaction to the diagnosis and its impact on their future will be assessed using a semi-structured interview with the patient |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression screening | Within 1 year of diagnosis for clot patients; after formal diagnosis for bleeding disorder patients | Screening completed using PHQ-9 questionnaire |
| Quality of life screening | Within 1 year of diagnosis for clot patients; after formal diagnosis for bleeding disorder patients | Screening completed using Peds QOL questionnaire |
| Menorrhagia screening for participants with bleeding disorders | Within 1 year of diagnosis for clot patients; after formal diagnosis for bleeding disorder patients | Screening completed using Menorrhagia impact questionnaire |
| Dalhousie Dypsnea screening for participants with clots | Within 1 year of diagnosis for clot patients; after formal diagnosis for bleeding disorder patients | Screening completed using Dalhousie Dypsnea questionnaire |
| Physical activity screening | Within 1 year of diagnosis for clot patients; after formal diagnosis for bleeding disorder patients | Screening completed using Godin Physical Activity questionnaire |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAyesha Zia, MD
University of Texas Southwestern Medical Center
Outcome results
None listed