The Lived Experience of People With Von Willebrand Disease

NCT06064643 | Completed

• 1 other identifier: v1.0 dated 15 June 2023
• Study Type: observational
• Target: 611
• Locations: 1 country
• Sites: 1

Brief Summary

von Willebrand disease (vWD) is reported to be the most common bleeding disorder, with prevalence estimated at 1% of the general population. Despite this, little is known about its natural history, or of the impact it has on affected individuals and their families. The Haemnet vWD360 programme is a mixed-methods, natural history study designed to gain a greater understanding of vWD and its impact on individuals and their families. It comprises both qualitative and quantitative approaches and is designed to include the perspectives of individuals with a diagnosis of any subtype of vWD. The vWD360 study includes three components:

• Quantitative cross-sectional survey
• Qualitative one-to-one interviews with affected individuals
• 30-day bleed diary.

Conditions

Von Willebrand Diseases

Outcome Measures

Primary Outcomes (3)

• Bleeding Episodes

  To identify differences in bleeding type and rate between sub-types of vWD

  Survey - The month prior to completing the survey. Bleed Diary - 30 days from consent.

• Pain experiences

  To identify evidence of chronic and acute pain between sub-types of vWD

  Survey - The month prior to completion of the survey

• Daily Activities

  To identify differences in daily activity between sub-types of vWD

  Survey - one month prior to completion of the survey. Interview - life historical

Study Arms (3)

Survey Arm

All participants will be asked to complete an online survey

Other: Online Survey

Interview Arm

A sample of the survey group will be asked to take part in a single qualitative interview

Other: Qualitative Interview

Bleed Diary Arm

A sample of the survey group will be asked to take part in a 30 day bleed diary

Other: Bleed Diary

Interventions

Online Survey OTHER

All participants will be asked to complete an online survey

Survey Arm

Qualitative Interview OTHER

30 survey participants will take part in a single one-hour qualitative interview.

Interview Arm

Bleed Diary OTHER

50 participants will complete a 30 day bleed diary

Bleed Diary Arm

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with a confirmed diagnosis of von Willebrands disease, aged 16 yrs and older (18 yrs and older in the US).

You may qualify if:

• Adults aged 16 and above (UK and Ireland) and adults aged over 18 (in USA) with a confirmed diagnosis of inherited vWD of known diagnostic subtype and vWF level.
• For the qualitative interview-based substudy, 30 adults who have completed the survey and who wish to be interviewed will be purposively selected for a broad range of ages and diagnostic subtype.
• For the bleed diary substudy, 50 adults who have completed the survey and who wish to take part will be purposively selected for a broad range of ages and diagnostic subtype.

You may not qualify if:

• Have acquired vWD
• Have other inherited bleeding disorders
• Do not wish to participate in or to consent to the study.
• Those for whom written/spoken English would prohibit participation will also be excluded.

Sponsors & Collaborators

• Haemnet: lead
• Hemab ApS: collaborator

Study Sites (1)

Oxford University Hospitals NHS Foundation Trust

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

von Willebrand Diseases

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Blood Platelet Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Simon Fletcher, MA

  Haemnet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 3, 2023
• Study Start: December 8, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-09

Locations

GB (1)