Examining the Experiences of Children With Blood Disorders

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Examining the Experiences of Children With Blood Disorders

Conditions
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Blood Disease, Thrombotic Disorder, Venous Thromboembolism, Hemostatic Disorder, Bleeding Disorder

Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |