Examining the Experiences of Children With Blood Disorders

Venous Thromboembolism Clinical Trial

Official title:

Examining the Experiences of Children With Blood Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04600609
• Other study ID #: STU-2020-0772
• Status: Recruiting
• Start date: November 9, 2020
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: University of Texas Southwestern Medical Center
• Contact: Ayesha Zia, MD
• Phone: 214-456-7000
• Email: Ayesha.Zia[@]utsouthwestern.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 21 Years

Eligibility

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).

Related Conditions & MeSH terms

• Bleeding Disorder
• Blood Coagulation Disorders
• Blood Disease
• Hematologic Diseases
• Hemostatic Disorder
• Hemostatic Disorders
• Thromboembolism
• Thrombosis
• Thrombotic Disorder
• Venous Thromboembolism

Locations

Country	Name	City	State
United States	The University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Depression screening	Screening completed using PHQ-9 questionnaire	Within 1 year of diagnosis for clot patients; after formal diagnosis for bleeding disorder patients
Secondary	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
Secondary	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
Secondary	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
Secondary	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