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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Quality of life assessment | 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 | Within 1 year of diagnosis for clot patients; after formal diagnosis for bleeding disorder patients |
| Patient confidence assessment | Patient confidence in managing blood disorder and recognizing emergencies will be assessed using a semi-structured interview with the patient | Within 1 year of diagnosis for clot patients; after formal diagnosis for bleeding disorder patients |
| Quality of care assessment | 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 | Within 1 year of diagnosis for clot patients; after formal diagnosis for bleeding disorder patients |
| Implications on the future for the patient with the bleeding disorder | Patient's reaction to the diagnosis and its impact on their future will be assessed using a semi-structured interview with the patient | Within 1 year of diagnosis for clot patients; after formal diagnosis for bleeding disorder patients |
| Measure | Description | Time Frame |
|---|---|---|
| Depression screening | Screening completed using PHQ-9 questionnaire | Within 1 year of diagnosis for clot patients; after formal diagnosis for bleeding disorder patients |
| Quality of life screening |
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Inclusion Criteria:
Exclusion Criteria:
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Study population will include children (defined as persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted), patients (defined as individuals in a clinical setting with whom there is a treatment relationship), and non-English speakers.
Patients must meet the eligibility criteria in order to participate in this trial.
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| Name | Affiliation | Role |
|---|---|---|
| Ayesha Zia, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Southwestern Medical Center | Dallas | Texas | 75235 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35664533 | Background | Parker M, Hannah M, Zia A. "If I wasn't a girl": Experiences of adolescent girls with heavy menstrual bleeding and inherited bleeding disorders. Res Pract Thromb Haemost. 2022 May 30;6(4):e12727. doi: 10.1002/rth2.12727. eCollection 2022 May. |
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| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D013927 | Thrombosis |
| D054556 | Venous Thromboembolism |
| D020141 | Hemostatic Disorders |
| ID | Term |
|---|---|
| D006425 | Hemic and Lymphatic Diseases |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Screening completed using Peds QOL questionnaire
| Within 1 year of diagnosis for clot patients; after formal diagnosis for bleeding disorder patients |
| Menorrhagia screening for participants with bleeding disorders | Screening completed using Menorrhagia impact questionnaire | Within 1 year of diagnosis for clot patients; after formal diagnosis for bleeding disorder patients |
| Dalhousie Dypsnea screening for participants with clots | Screening completed using Dalhousie Dypsnea questionnaire | Within 1 year of diagnosis for clot patients; after formal diagnosis for bleeding disorder patients |
| Physical activity screening | Screening completed using Godin Physical Activity questionnaire | Within 1 year of diagnosis for clot patients; after formal diagnosis for bleeding disorder patients |
| D013923 | Thromboembolism |
| D006474 | Hemorrhagic Disorders |