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Improving Identification of Familial Hypercholesterolaemia in Primary Care (FAMCAT)

NCT03934320 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2019-05-01

No results posted yet for this study

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.

Conditions

  • Familial Hypercholesterolemia

Interventions

OTHER

FAMCAT

The intervention is a computer-based software algorithm (FAMCAT) for use in general practice with a family history questionnaire.

Sponsors & Collaborators

  • Newcastle University

    collaborator OTHER

  • University College, London

    collaborator OTHER

  • University of Manchester

    collaborator OTHER

  • University of Nottingham

    lead OTHER

Principal Investigators

  • Nadeem Qureshi, DM · University of Nottingham

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-12
Primary Completion
2020-07-31
Completion
2020-07-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03934320 on ClinicalTrials.gov