A Study to Create a Patient Decision Aid for Familial Hypercholesterolemia to Promote Shared Decision Making Between Patients and Physicians

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 16-006828
    Sponsor Protocol Number: 16-006828

About this study

The purpose of this study is to assist patients and clinicians in discussing the potential benefits and side effects of treatment of familial hypercholesterolemia (FH) and to develop a decision aid for use in a clinical setting.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Focus Group Discussion;
    • Patients with FH
      • Adults >18 years
      • Available for 60-90 minutes
    • Physicians
      • Consultants in the Mayo Clinic Network
      • Regularly see patients in an outpatient setting
  • Observations of Clinical Encounters and Field Testing and Iterative Development;
    • Patients
      • Adults ≥18 years
      • Appointment for FH treatment follow up OR appointment for initial FH consultation
    • Clinicians
      • Clinicians who meet with patients for treatment of FH
    • FH Patient Family Members
      • Adults ≥ 18 years
  • Focus Group Discussion;
    • Patients
      • Adults ≥18 years
      • Previous diagnosis of FH
      • Not involved in developing PDA or field testing PDA
    • Physicians
      • Consultants in the Mayo Clinic Network
      • Regularly see patients in an outpatient setting
      • Not involved in the initial development process of the decision aid or field testing
  • Patient Advisory Group (PAG);
    • Patients
      • Age >18

Exclusion Criteria:

  • Focus Group Discussion;
    • Patients with FH
      • Major barriers to providing informed consent (i.e dementia, severe hearing, or visual impairment)
    • Physicians
      • None
  • Observations of Clinical Encounters and Field Testing and Iterative Development;
    • Patients
      • Major barriers to providing informed consent (i.e. dementia, severe hearing or visual impairment)
    • Clinicians
      • None
    • FH Patient Family Members
      • None
  • Focus Group Discussion;
    • Patients
      • Major barriers to providing informed consent (i.e dementia, severe hearing, or visual impairment)
      • Prior involvement in the decision aid during the study
    • Physicians
      • Prior involvement in the decision aid during the study
  • Patient Advisory Group (PAG)
    • Patients
      • Major barriers to providing informed consent (i.e dementia, severe hearing loss, or visual impairment)

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Iftikhar Kullo, M.D.

Open for enrollment

Contact information:

Ashley Pitzer

(608)392-9521

Pitzer.Ashley@mayo.edu

.
CLS-20306927

Mayo Clinic Footer