Familial HypercholesterolemiaFAMCATNCT03934320
Improving Identification of Familial Hypercholesterolaemia in Primary Care (FAMCAT)
A study testing FAMCAT in people with Familial Hypercholesterolemia, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Multi-centre, non-randomised, non-controlled quasi-experimental study with nested qualitative study and economic appraisal. Improving the identification of patients at high risk of cardiovascular disease in primary care, caused by conditions such as familial hypercholesterolaemia (FH), is a well-recognised national… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Familial Hypercholesterolemia
- What is being tested?
- FAMCAT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Jun 2017to 31 Jul 2020
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Division of Primary Care, University of Nottingham
Nottingham, Nottinghamshire, NG7 2UH
About this study
Official title: Improving Identification of Familial Hypercholesterolaemia in Primary Care Using a New Case Ascertainment Tool (FAMCAT)
Multi-centre, non-randomised, non-controlled quasi-experimental study with nested qualitative study and economic appraisal.
Improving the identification of patients at high risk of cardiovascular disease in primary care, caused by conditions such as familial hypercholesterolaemia (FH), is a well-recognised national priority to prevent morbidity and mortality by early effective intervention.
Read more
This study will prospectively evaluate the clinical utility of the new primary care FH identification tool (FAMCAT) for identifying undiagnosed FH in routine primary care practice; and to assess its appropriateness, acceptability and cost-effectiveness.
This study will answer the following research questions (RQ):
- What is the detection rate for new genetically-confirmed FH cases using the FAMCAT algorithm?
- Is the FAMCAT tool appropriate and acceptable to practitioners and patients?
- How can the FAMCAT tool be optimised to improve identification of FH?
- What is the potential cost-effectiveness of the FAMCAT tool compared with current practice to identify patients with FH?
- Can the FAMCAT intervention be improved?
- What definitive study design and outcome measures are needed to provide robust evidence on whether to introduce FAMCAT into primary care practice?
RQ(1) \& (3) will be answered by a quasi-experimental diagnostic accuracy study; RQ(2) \& (5) answered by qualitative study; RQ (4) answered by economic appraisal and RQ(6) informed by all previous studies.
- Conditions
- Familial Hypercholesterolemia
- Being tested
- FAMCAT
- Medical subject headings
- Hyperlipoproteinemia Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAMCATOther
The intervention is a computer-based software algorithm (FAMCAT) for use in general practice with a family history questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| FAMCAT | Other | Not described Receives: Other: FAMCAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of genetically confirmed new FH cases using case identification tool (FAMCAT)
Efficacy measure: Proportion (%) of genetically-confirmed FH cases Proportion (%) of genetically-confirmed FH cases
Measured: Through study completion, an average of 2 years
Secondary outcomes (7)
Acceptability of FAMCAT
Efficacy measure: representativeness of qualitative interview sample. Key themes will be identified from qualitative interview transcripts of patient experience of participating in the study, acceptability of the study procedures (ie. location of blood test clinic appointments, waiting time to receive test results) , and appropriateness of methods of contact with study participants (ie. format and content of study materials, communicating test results). Key themes on usability will be identified from qualitative interview transcripts of health care professionals who used the FAMCAT tool clinically (ie. search criteria for clinical records, interpretation of results)
Measured: Through study completion, an average of 2 years.
Appropriateness of FAMCAT
Efficacy measure: representativeness of qualitative interview sample. Key themes will be identified from qualitative interview transcripts of patient experience of appropriateness of methods of contact with study participants (ie. format and content of study materials, communicating test results).
Measured: Through study completion, an average of 2 years.
Usability of FAMCAT
Efficacy measure: representativeness of qualitative interview sample. Key themes on usability will be identified from qualitative interview transcripts of health care professionals who used the FAMCAT tool clinically (ie. search criteria for clinical records, interpretation of results)
Measured: Through study completion, an average of 2 years.
Self-reported anxiety measures for use in a future trial
Anxiety measured using 6 item Spielberger State-Trait Anxiety Inventory (STAI). The total score will be calculated at study entry, after receiving genetic test results and 12- 15 months after genetic tests results received
Measured: Baseline to 15 months after genetic test results reported
Self-reported lifestyle change measures for use in a future trial
Stages of change for smoking cessation and physical activity will be measured. The five stages of change will be dichotomised into: (1) pre-contemplation, contemplation and preparation and (2) action/maintenance. The distribution of proportions for each measure will be presented at study entry, after receiving genetic test results and 12- 15 months after genetic tests results received
Measured: Baseline to 15 months after genetic test results reported
Beliefs about predisposition to coronary heart disease
Beliefs on causes for heart disease were assessed using 8 items, from a total of 18 items, which comprise the 'Causes of my illness' subscale in the Revised Illness Perception Questionnaire, IPQ-R.
The distribution of data for each one of the 8 questions will be presented at study entry, after receiving genetic test results and 12- 15 months after genetic tests results received
Measured: Baseline to 15 months after genetic test results reported
Cost-effective FAMCAT threshold to identify genetically confirmed FH
Efficacy measure: Primary analysis:
Incremental cost-effectiveness ratio (ICER) of FAMCAT compared to Simon-Broome criteria; Sensitivity analysis: Incremental costeffectiveness ratio (ICER) of FAMCAT at different testing thresholds. Short-term model: 24 Months
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start12 Jun 2017
- Primary completion31 Jul 2020 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Familial HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Newcastle University, University College, London, University of Manchester
- Responsible party
- Sponsor
- Investigators
- Nadeem Qureshi, DM, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03934320
- Sponsor's protocol ID
- 16090
- Other IDs
- 332
- Acronym
- FAMCAT
- Status last verified
- Apr 2019
- First submitted
- 8 Mar 2019
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not have consent from participants to share their data for the purposes of future research.
Publications
Qureshi N, Akyea RK, Dutton B, Leonardi-Bee J, Humphries SE, Weng S, Kai J. Comparing the performance of the novel FAMCAT algorithms and established case-finding criteria for familial hypercholesterolaemia in primary care. Open Heart. 2021 Oct;8(2):e001752. doi: 10.1136/openhrt-2021-001752.
PubMed 34635577Qureshi N, Akyea RK, Dutton B, Humphries SE, Abdul Hamid H, Condon L, Weng SF, Kai J; FAMCAT study. Case-finding and genetic testing for familial hypercholesterolaemia in primary care. Heart. 2021 Dec;107(24):1956-1961. doi: 10.1136/heartjnl-2021-319742. Epub 2021 Sep 14.
PubMed 34521694
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Identification of Familial Hypercholesterolaemia in Primary Care Using a New Case Ascertainment Tool (FAMCAT)
- ClinicalTrials.gov ID
- NCT03934320
- Acronym / sponsor ID
- FAMCAT / 16090
- Conditions
- Familial Hypercholesterolemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Newcastle University, University College, London, University of Manchester
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 1 May 2019 (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.
Multi-centre, non-randomised, non-controlled quasi-experimental study with nested qualitative study and economic appraisal.
Improving the identification of patients at high risk of cardiovascular disease in primary care, caused by conditions such as familial hypercholesterolaemia (FH), is a well-recognised national priority to prevent morbidity and mortality by early effective intervention.
This study will prospectively evaluate the clinical utility of the new primary care FH identification tool (FAMCAT) for identifying undiagnosed FH in routine primary care practice; and to assess its appropriateness, acceptability and cost-effectiveness.
This study will answer the following research questions (RQ):
- What is the detection rate for new genetically-confirmed FH cases using the FAMCAT algorithm?
- Is the FAMCAT tool appropriate and acceptable to practitioners and patients?
- How can the FAMCAT tool be optimised to improve identification of FH?
- What is the potential cost-effectiveness of the FAMCAT tool compared with current practice to identify patients with FH?
- Can the FAMCAT intervention be improved?
- What definitive study design and outcome measures are needed to provide robust evidence on whether to introduce FAMCAT into primary care practice?
RQ(1) \& (3) will be answered by a quasi-experimental diagnostic accuracy study; RQ(2) \& (5) answered by qualitative study; RQ (4) answered by economic appraisal and RQ(6) informed by all previous studies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FAMCAT | Other | Other: FAMCAT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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
Key exclusion criteria (24 listed)
- 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
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 |
|---|---|---|
| FAMCATThe intervention is a computer-based software algorithm (FAMCAT) for use in general practice with a family history questionnaire. | Other | FAMCAT |
Primary outcome
Detection of genetically confirmed new FH cases using case identification tool (FAMCAT)
Time frame: Through study completion, an average of 2 years
Efficacy measure: Proportion (%) of genetically-confirmed FH cases Proportion (%) of genetically-confirmed FH cases
7 secondary outcomes
Acceptability of FAMCAT
Time frame: Through study completion, an average of 2 years.
Appropriateness of FAMCAT
Time frame: Through study completion, an average of 2 years.
Usability of FAMCAT
Time frame: Through study completion, an average of 2 years.
Self-reported anxiety measures for use in a future trial
Time frame: Baseline to 15 months after genetic test results reported
Self-reported lifestyle change measures for use in a future trial
Time frame: Baseline to 15 months after genetic test results reported
Beliefs about predisposition to coronary heart disease
Time frame: Baseline to 15 months after genetic test results reported
Cost-effective FAMCAT threshold to identify genetically confirmed FH
Time frame: through study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
- Derived from this study: PubMed 34635577Qureshi N, Akyea RK, Dutton B, Leonardi-Bee J, Humphries SE, Weng S, Kai J. Comparing the performance of the novel FAMCAT algorithms and established case-finding criteria for familial hypercholesterolaemia in primary care. Open Heart. 2021 Oct;8(2):e001752. doi: 10.1136/openhrt-2021-001752.
- Derived from this study: PubMed 34521694Qureshi N, Akyea RK, Dutton B, Humphries SE, Abdul Hamid H, Condon L, Weng SF, Kai J; FAMCAT study. Case-finding and genetic testing for familial hypercholesterolaemia in primary care. Heart. 2021 Dec;107(24):1956-1961. doi: 10.1136/heartjnl-2021-319742. Epub 2021 Sep 14.
- Funder websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. We do not have consent from participants to share their data for the purposes of future research.
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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.
Nadeem Qureshi, DM principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FAMCAT in people with Familial Hypercholesterolemia, run by University of Nottingham 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 22 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 1 May 2019. 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?
Results are not available in the source record.
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?
Detection of genetically confirmed new FH cases using case identification tool (FAMCAT) (time frame: Through study completion, an average of 2 years). 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 NCT03934320, which also lists 2 linked publications.
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 1 May 2019.