Blood DiseaseNCT04600609
Examining the Experiences of Children With Blood Disorders
An observational study of Blood Disease and Thrombotic Disorder, run by University of Texas Southwestern Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Blood Disease, Thrombotic Disorder, Venous Thromboembolism
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2020to 27 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients will be excluded if they do not have access to the technology needed to participate in a virtual interview visit (by telephone).
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Southwestern Medical Center
Dallas, Texas, 75235
About this study
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.
Read the 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.
- Conditions
- Blood Disease, Thrombotic Disorder, Venous Thromboembolism, Hemostatic Disorder, Bleeding Disorder
- Medical subject headings
- Hematologic Diseases, Thrombosis, Venous Thromboembolism, Hemostatic Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Within 1 year of diagnosis for clot patients; after formal diagnosis for bleeding disorder patients
Secondary outcomes (5)
Depression screening
Screening completed using PHQ-9 questionnaire
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Within 1 year of diagnosis for clot patients; after formal diagnosis for bleeding disorder patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start9 Nov 2020
- Primary completion27 Jun 2021
- Study completion27 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood DiseaseStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayesha Zia, University of Texas Southwestern Medical Center
- Investigators
- Ayesha Zia, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600609
- Sponsor's protocol ID
- STU-2020-0772
- Status last verified
- Feb 2026
- First submitted
- 22 Sep 2020
- Last updated
- 5 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35664533
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Experiences of Children With Blood Disorders
- ClinicalTrials.gov ID
- NCT04600609
- Acronym / sponsor ID
- STU-2020-0772
- Conditions
- Blood Disease, Thrombotic Disorder, Venous Thromboembolism, Hemostatic Disorder, Bleeding Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 27 Jun 2021 (actual)
- Study completion
- 27 Jun 2021 (actual)
- First posted
- 23 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients will be excluded if they do not have access to the technology needed to participate in a virtual interview visit (by telephone).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of life assessment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
5 secondary outcomes
Depression screening
Time frame: Within 1 year of diagnosis for clot patients; after formal diagnosis for bleeding disorder patients
Quality of life screening
Time frame: Within 1 year of diagnosis for clot patients; after formal diagnosis for bleeding disorder patients
Menorrhagia screening for participants with bleeding disorders
Time frame: Within 1 year of diagnosis for clot patients; after formal diagnosis for bleeding disorder patients
Dalhousie Dypsnea screening for participants with clots
Time frame: Within 1 year of diagnosis for clot patients; after formal diagnosis for bleeding disorder patients
Physical activity screening
Time frame: Within 1 year of diagnosis for clot patients; after formal diagnosis for bleeding disorder patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Background: PubMed 35664533Parker 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayesha Zia, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Disease and Thrombotic Disorder, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life assessment (time frame: Within 1 year of diagnosis for clot patients; after formal diagnosis for bleeding disorder patients). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04600609, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.