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

Primary Purpose

Familial Hypercholesterolemia

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
FAMCAT
Sponsored by
University of Nottingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Familial Hypercholesterolemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Division of Primary Care, University of Nottingham

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

FAMCAT

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
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).
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)
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
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
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
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

Full Information

First Posted
March 8, 2019
Last Updated
April 30, 2019
Sponsor
University of Nottingham
Collaborators
Newcastle University, University College, London, University of Manchester
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1. Study Identification

Unique Protocol Identification Number
NCT03934320
Brief Title
Improving Identification of Familial Hypercholesterolaemia in Primary Care (FAMCAT)
Acronym
FAMCAT
Official Title
Improving Identification of Familial Hypercholesterolaemia in Primary Care Using a New Case Ascertainment Tool (FAMCAT)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 12, 2017 (Actual)
Primary Completion Date
July 31, 2020 (Anticipated)
Study Completion Date
July 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham
Collaborators
Newcastle University, University College, London, University of Manchester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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): 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Familial Hypercholesterolemia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FAMCAT
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
FAMCAT
Intervention Description
The intervention is a computer-based software algorithm (FAMCAT) for use in general practice with a family history questionnaire.
Primary Outcome Measure Information:
Title
Detection of genetically confirmed new FH cases using case identification tool (FAMCAT)
Description
Efficacy measure: Proportion (%) of genetically-confirmed FH cases Proportion (%) of genetically-confirmed FH cases
Time Frame
Through study completion, an average of 2 years
Secondary Outcome Measure Information:
Title
Acceptability of FAMCAT
Description
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)
Time Frame
Through study completion, an average of 2 years.
Title
Appropriateness of FAMCAT
Description
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).
Time Frame
Through study completion, an average of 2 years.
Title
Usability of FAMCAT
Description
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)
Time Frame
Through study completion, an average of 2 years.
Title
Self-reported anxiety measures for use in a future trial
Description
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
Time Frame
Baseline to 15 months after genetic test results reported
Title
Self-reported lifestyle change measures for use in a future trial
Description
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
Time Frame
Baseline to 15 months after genetic test results reported
Title
Beliefs about predisposition to coronary heart disease
Description
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
Time Frame
Baseline to 15 months after genetic test results reported
Title
Cost-effective FAMCAT threshold to identify genetically confirmed FH
Description
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
Time Frame
through study completion, an average of 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadeem Qureshi, DM
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Primary Care, University of Nottingham
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG7 2UH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We do not have consent from participants to share their data for the purposes of future research.
Citations:
PubMed Identifier
34635577
Citation
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.
Results Reference
derived
PubMed Identifier
34521694
Citation
Qureshi 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.
Results Reference
derived
Links:
URL
https://www.spcr.nihr.ac.uk/projects/improving-identification-of-familial-hypercholesterolaemia-in-primary-care-using-a-new-case-ascertainment-tool-famcat
Description
Funder website

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Improving Identification of Familial Hypercholesterolaemia in Primary Care (FAMCAT)

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