A Study to Create a Patient Decision Aid for Familial Hypercholesterolemia to Promote Shared Decision Making Between Patients and Physicians
Overview
Tab Title Description
Study type
InterventionalDescribes 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.
Study IDs
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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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
- 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);
Exclusion Criteria:
- Focus Group Discussion;
- Patients with FH
- Major barriers to providing informed consent (i.e dementia, severe hearing, or visual impairment)
- Physicians
- 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
- FH Patient Family Members
- 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 the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Iftikhar Kullo, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available