Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-25 @ 4:19 AM
NCT ID:
NCT03934320
Eligibility Criteria:
Inclusion Criteria:
Patients - General practices
* Able to give written informed consent
* 18 years of age or over
* Serum cholesterol recorded in General Practice (GP) electronic records
* Registered with a participating GP practice
* Able to complete the self-administered questionnaires in English
* No previous recorded diagnosis of familial hypercholesterolaemia in their GP electronic health records
* Considered by their General Practitioner(s) to be appropriate to recruit to the study.
Patients - Secondary care
* Able to give written informed consent
* 18 years of age or over
* Referred to or under the care of participating Trusts (e.g. lipid clinics)
* Able to understand the study information and consent in English
* Considered by their healthcare professions to be appropriate to recruit to the study.
Staff
* Able to give written informed consent
* 18 years of age or over
* Working at a participating General Practice, Clinical Commissioning Group (CCG) or Secondary Care Trust.
Nominal Group
* Able to give written informed consent
* 18 years of age or over
* A FH stakeholder (including specialists, primary care commissioners, FH patient representative)
Exclusion Criteria:
Patients - General practices
* Unable to give written informed consent
* Under 18 years of age
* Serum cholesterol not recorded in GP electronic records
* Not registered with a participating GP practice
* Unable to complete the self-administered questionnaires in English
* Has a diagnosis of familial hypercholesterolaemia in their GP electronic records
* Unable to have a blood test (for medical or personal reasons)
* Have an opt-out code where patients has declined electronic medical records examined
* Considered by their General Practitioner(s) to be inappropriate to recruit due to psycho-social reasons, participating in another related clinical trial or significant health reasons, e.g. terminal illness/diagnosis.
Patients - Secondary care
* Unable to give written informed consent
* Under 18 years of age
* Not referred to or under the care of participating Trusts (e.g. lipid clinics)
* Unable to understand the study information and consent in English
* Considered by their healthcare professionals to be inappropriate to recruit to the study.
Staff
* Unable to give written informed consent
* Under 18 years of age
* Has not worked at a participating General Practice, CCG or Secondary Care Trust.
Nominal Group
* Unable to give written informed consent
* Under 18 years of age
* Not an FH stakeholder or FH patient representative
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03934320
Study Brief:
Protocol Section:
NCT03934320