Examining the Experiences of Children With Blood Disorders

NCT04600609 | Completed

• 1 other identifier: STU-2020-0772
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Disease; Thrombotic Disorder; Venous Thromboembolism; Hemostatic Disorder; Bleeding Disorder

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Depression screening

  Within 1 year of diagnosis for clot patients; after formal diagnosis for bleeding disorder patients

• Quality of life screening

  Within 1 year of diagnosis for clot patients; after formal diagnosis for bleeding disorder patients

• Menorrhagia screening for participants with bleeding disorders

  Within 1 year of diagnosis for clot patients; after formal diagnosis for bleeding disorder patients

• Dalhousie Dypsnea screening for participants with clots

  Within 1 year of diagnosis for clot patients; after formal diagnosis for bleeding disorder patients

• Physical activity screening

  Within 1 year of diagnosis for clot patients; after formal diagnosis for bleeding disorder patients

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• Patients will be excluded if they do not have access to the technology needed to participate in a virtual interview visit (by telephone).

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

The University of Texas Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

Related Publications (1)

• 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.

  PMID: 35664533 BACKGROUND

MeSH Terms

Conditions

Hematologic Diseases; Thrombosis; Venous Thromboembolism; Hemostatic Disorders

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thromboembolism; Hemorrhagic Disorders

Study Officials

• Ayesha Zia, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: October 23, 2020
• Study Start: November 9, 2020
• Primary Completion: June 27, 2021
• Study Completion: June 27, 2021
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

US (1)