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Improving Identification of Familial Hypercholesterolaemia in Primary Care (FAMCAT) (FAMCAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03934320
Recruitment Status : Unknown
Verified April 2019 by University of Nottingham.
Recruitment status was:  Enrolling by invitation
First Posted : May 1, 2019
Last Update Posted : May 1, 2019
Sponsor:
Collaborators:
Newcastle University
University College, London
University of Manchester
Information provided by (Responsible Party):
University of Nottingham

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 Intervention/treatment Phase
Familial Hypercholesterolemia Other: FAMCAT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: N/A
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 12, 2017
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020


Arm Intervention/treatment
FAMCAT Other: FAMCAT
The intervention is a computer-based software algorithm (FAMCAT) for use in general practice with a family history questionnaire.




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




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03934320


Locations
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United Kingdom
Division of Primary Care, University of Nottingham
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
Sponsors and Collaborators
University of Nottingham
Newcastle University
University College, London
University of Manchester
Investigators
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Principal Investigator: Nadeem Qureshi, DM University of Nottingham
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT03934320    
Other Study ID Numbers: 16090
332 ( Other Grant/Funding Number: NIHR School for Primary Care Research )
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyperlipoproteinemia Type II
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias