Glanzmann ThrombastheniaNCT05315232
The Experiences of People Who Live With Glanzmanns Thrombasthenia.
An observational study of Glanzmann Thrombasthenia, run by Haemnet at 1 site in United Kingdom.
Trial summary
To understand the lived experiences of people with Glanzmanns Thrombasthenia Read more about this study
- Who is it for?
- Ages 0 to 100 years
- Conditions the study is for
- Glanzmann Thrombasthenia
- What is being tested?
- survey and interview
- How many people
- 122 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Apr 2022to 27 Apr 2023
- 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 0 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: People with Glanzmanns Thrombasthenia or parents of children with Glanzmanns Thrombasthenia.
Who may be able to join
- Clinical diagnosis of congenital (inherited) Glanzmanns Thrombasthenia
Who cannot join
- Acquired Glanzmanns Thrombasthenia
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, OX3 7LE
About this study
Official title: Glanzmanns 360. The Lived Experience of People With Glanzmanns.
To understand the lived experiences of people with Glanzmanns Thrombasthenia
Read the detailed description
A qualitative study of people with Glanzmanns Thrombasthenia including an on-line survey, qualitative in-depth interviews and bleed diary completion.
- Conditions
- Glanzmann Thrombasthenia
- Being tested
- survey and interview
- Medical subject headings
- Thrombasthenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
survey and interviewOther
Also called diary completion
qualitative assessment
| Study group | Role | What they receive |
|---|---|---|
| Qualitative assessment | Survey (using validated quality of life assessment questionnaires) and one to one interviews of people and family members living with Glanzmanns Thrombasthenia Receives: Other: survey and interview | |
| Bleed diary | Daily bleed diary completion over 12 weeks Receives: Other: survey and interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
to understand the impact of GT on quality of life of affected individuals and their families.
Incidence of reported impact of GT on daily life using validated questionnaires EQ5D, MIQ, PHQ9, Rosenbergs self esteem scale.
Measured: one year
Secondary outcomes (2)
Identify levels of acceptability of current treatments and management approaches
Rate of reported satisfaction with current treatments using self efficacy to manage disease assessment tool
Measured: one year
Identify areas of unmet need among people with GT
Rate of reported unmet need using ED5D and MIQ
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start27 Apr 2022
- Primary completion27 Apr 2023
- Study completion27 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glanzmann ThrombastheniaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haemnet
- Sponsor type
- University, hospital or other
- Collaborators
- Hemab ApS
- Responsible party
- Sponsor
- Investigators
- Mike Holland, BSC, Study director, Haemnet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315232
- Sponsor's protocol ID
- Glanzmanns 360
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2022
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The second part of the study will be conducted by Haemnet and Hemab - participant information will be shared after reconsenting
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glanzmanns 360. The Lived Experience of People With Glanzmanns.
- ClinicalTrials.gov ID
- NCT05315232
- Acronym / sponsor ID
- Glanzmanns 360
- Conditions
- Glanzmann Thrombasthenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- HaemnetUniversity, hospital or other
- Collaborators
- Hemab ApS
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- 27 Apr 2023 (actual)
- Study completion
- 27 Apr 2023 (actual)
- First posted
- 7 Apr 2022 (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.
To understand the lived experiences of people with Glanzmanns Thrombasthenia
Detailed description
A qualitative study of people with Glanzmanns Thrombasthenia including an on-line survey, qualitative in-depth interviews and bleed diary completion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Qualitative assessment | – | Other: survey and interviewSurvey (using validated quality of life assessment questionnaires) and one to one interviews of people and family members living with Glanzmanns Thrombasthenia |
| Bleed diary | – | Other: survey and interviewDaily bleed diary completion over 12 weeks |
Who may qualify
- Ages
- 0 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People with Glanzmanns Thrombasthenia or parents of children with Glanzmanns Thrombasthenia.
Key inclusion criteria (1 listed)
- Clinical diagnosis of congenital (inherited) Glanzmanns Thrombasthenia
Key exclusion criteria (1 listed)
- Acquired Glanzmanns Thrombasthenia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| survey and interviewAlso: diary completionqualitative assessment | Other | Bleed diary, Qualitative assessment |
Primary outcome
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.
2 secondary outcomes
Identify levels of acceptability of current treatments and management approaches
Time frame: one year
Identify areas of unmet need among people with GT
Time frame: one year
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 13 Mar 2024.
- Individual participant dataSharing planned: Yes. The second part of the study will be conducted by Haemnet and Hemab - participant information will be shared after reconsenting
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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.
Mike Holland, BSC study director
Haemnet
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 Glanzmann Thrombasthenia, run by Haemnet at 1 site in United Kingdom.
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 13 Mar 2024. 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 Kingdom. 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?
to understand the impact of GT on quality of life of affected individuals and their families. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2024.