The Experiences of People Who Live With Glanzmanns Thrombasthenia.

March 12, 2024 updated by: Haemnet

Glanzmanns 360. The Lived Experience of People With Glanzmanns.

To understand the lived experiences of people with Glanzmanns Thrombasthenia

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A qualitative study of people with Glanzmanns Thrombasthenia including an on-line survey, qualitative in-depth interviews and bleed diary completion.

Study Type

Observational

Enrollment (Actual)

122

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7LE
        • Oxford University Hospitals NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

People with Glanzmanns Thrombasthenia or parents of children with Glanzmanns Thrombasthenia.

Description

Inclusion Criteria:

Clinical diagnosis of congenital (inherited) Glanzmanns Thrombasthenia

Exclusion Criteria:

Acquired Glanzmanns Thrombasthenia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Qualitative assessment
Survey (using validated quality of life assessment questionnaires) and one to one interviews of people and family members living with Glanzmanns Thrombasthenia
Other: survey and interview
qualitative assessment
Other Names:
  • diary completion
Bleed diary
Daily bleed diary completion over 12 weeks
Other: survey and interview
qualitative assessment
Other Names:
  • diary completion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to understand the impact of GT on quality of life of affected individuals and their families.
Time Frame: one year
Incidence of reported impact of GT on daily life using validated questionnaires EQ5D, MIQ, PHQ9, Rosenbergs self esteem scale.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify levels of acceptability of current treatments and management approaches
Time Frame: one year
Rate of reported satisfaction with current treatments using self efficacy to manage disease assessment tool
one year
Identify areas of unmet need among people with GT
Time Frame: one year
Rate of reported unmet need using ED5D and MIQ
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haemnet

Collaborators

Hemab ApS

Investigators

  • Study Director: Mike Holland, BSC, Haemnet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2022

Primary Completion (Actual)

April 27, 2023

Study Completion (Actual)

April 27, 2023

Study Registration Dates

First Submitted

March 15, 2022

First Submitted That Met QC Criteria

March 29, 2022

First Posted (Actual)

April 7, 2022

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Glanzmanns 360

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The second part of the study will be conducted by Haemnet and Hemab - participant information will be shared after reconsenting

IPD Sharing Time Frame

3-6 months

IPD Sharing Supporting Information Type

  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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