About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

378040 studies
in
220 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Improving Identification of Familial Hypercholesterolaemia in Primary Care (FAMCAT)

Clinicaltrials.gov identifier NCT03934320

Recruitment Status Enrolling by invitation

First Posted May 1, 2019

Last update posted May 1, 2019

Study Description

Brief 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 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): 1. What is the detection rate for new genetically-confirmed FH cases using the FAMCAT algorithm? 2. Is the FAMCAT tool appropriate and acceptable to practitioners and patients? 3. How can the FAMCAT tool be optimised to improve identification of FH? 4. What is the potential cost-effectiveness of the FAMCAT tool compared with current practice to identify patients with FH? 5. Can the FAMCAT intervention be improved? 6. 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.

  • Condition or Disease:Familial Hypercholesterolemia
  • Intervention/Treatment: Other: FAMCAT
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 400 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Diagnostic
  • Official Title: Improving Identification of Familial Hypercholesterolaemia in Primary Care Using a New Case Ascertainment Tool (FAMCAT)
  • Actual Study Start Date: June 2017
  • Estimated Primary Completion Date: July 2020
  • Estimated Study Completion Date: July 2020
Arms and interventions
Arm Intervention/treatment
Other: FAMCAT
Other: FAMCAT
The intervention is a computer-based software algorithm (FAMCAT) for use in general practice with a family history questionnaire.
Outcome Measures
  • Primary Outcome Measures: 1. 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
  • Secondary Outcome Measures: 1. Acceptability of FAMCAT [ Time Frame: Through study completion, an average of 2 years. ]
    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)
  • 2. Appropriateness of FAMCAT [ Time Frame: Through study completion, an average of 2 years. ]
    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).
  • 3. Usability of FAMCAT [ Time Frame: Through study completion, an average of 2 years. ]
    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)
  • 4. Self-reported anxiety measures for use in a future trial [ Time Frame: Baseline to 15 months after genetic test results reported ]
    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
  • 5. Self-reported lifestyle change measures for use in a future trial [ Time Frame: Baseline to 15 months after genetic test results reported ]
    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
  • 6. Beliefs about predisposition to coronary heart disease [ Time Frame: Baseline to 15 months after genetic test results reported ]
    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
  • 7. Cost-effective FAMCAT threshold to identify genetically confirmed FH [ Time Frame: through study completion, an average of 2 years ]
    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
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
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

Contacts and Locations
Contacts
Locations

United Kingdom, Nottinghamshire
Division of Primary Care, University of Nottingham
Nottingham

Sponsors and Collaborators

University of Nottingham

Newcastle University

University College, London

University of Manchester

Investigators

Principal Investigator: Nadeem Qureshi, DM University of Nottingham

More Information
  • Responsible Party: University of Nottingham
  • ClinicalTrials.gov Identifier: NCT03934320 History of Changes
  • Other Study ID Numbers: 16090, 332
  • First Posted: May 1, 2019 Key Record Dates
  • Last Update Posted: May 1, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Plan Description: We do not have consent from participants to share their data for the purposes of future research.
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Hypercholesterolemia Hyperlipoproteinemia Type II