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Motivational Interviewing for High Cholesterol (ID-FH Trial)

Q: What are the main goals that we hope to achieve with this clinical trial?

The primary aim of this study, which will last for 6 months post-intervention, is to increase knowledge about familial hypercholesterolemia. Additionally, the research team hopes to observe a change in the proportion of patients with LDL below 70 and 100, as well as an increase in self-reported genetic testing among participants.

Q: How many research subjects are included in this investigation?

Yes, this is an active trial that is looking for 200 patients from 2 sites. The listing was first posted on February 15th, 2022 and updated the next day.

Q: Is there a danger in using Motivational interview (MI) with patients?

Motivational interview (MI) received a score of 3 because there is evidence to support its efficacy and multiple rounds of data affirming its safety.

Q: How can I sign up for the research project?

This study is admitting 200 participants with genetic disease between the ages of 2 and 75. Most importantly, candidates are required to meet the following criteria: Age 2-75 years, patients with existing clinical diagnosis or suspected FH, known genetic mutation of FH, patients currently taking a lipid-lowering medication and have an LDL >124 mg/dL or total <a href="https://www.withpower.com/clinical-trials/cholesterol">cholesterol</a> >195 mg/dL, capable of providing informed consent, Patients should reside in <a href="https://www.withpower.com/clinical-trials/minnesota">Minnesota</a>, <a href="https://www.withpower.com/clinical-trials/wisconsin">Wisconsin</a> or <a href="https://www.withpower.com/clinical-trials/north-dakota">North dakota</a>., patients with an initial (pretreatment) LDL level >190 mg/dL or total cholesterol >300 mg/dL (age >19 years) or

Phase 3

Recruiting

Research Sponsored by Essentia Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients currently taking a lipid-lowering medication and have an LDL >124 mg/dL or total cholesterol >195 mg/dL

Patients with existing clinical diagnosis or suspected FH

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months post enrollment

Awards & highlights

ID-FH Trial Summary

This trial is testing a motivational interview to help patients with Familial Hypercholesterolemia (FH) manage their disease. The goal is to see if this leads to better outcomes.

Who is the study for?

This trial is for people aged 2-75 in Minnesota, Wisconsin, or North Dakota with suspected or confirmed Familial Hypercholesterolemia (FH) and high cholesterol levels despite taking medication. It's not for those who can't consent, pregnant women, prisoners, non-English speakers without research authorization, or if they have other conditions causing high cholesterol.Check my eligibility

What is being tested?

The study tests whether motivational interviews can improve knowledge of FH and patient outcomes compared to usual care. Participants will be randomly assigned to either receive these interviews or continue with their regular treatment routine.See study design

What are the potential side effects?

Since the intervention involves motivational interviewing—a psychological strategy to encourage positive behavior change—there are no direct medical side effects. However, participants may experience emotional discomfort discussing their condition.

ID-FH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am on cholesterol medication but my LDL is over 124 or total cholesterol is over 195.

Select...

I have or might have familial hypercholesterolemia (FH).

Select...

I am between 2 and 75 years old.

Select...

I have a known FH mutation.

Select...

I can understand and agree to the study's details.

Select...

My cholesterol or LDL levels were high before treatment.

ID-FH Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months post enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months post enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cascade screening of 1st degree family members

Knowledge of familial hypercholesterolemia

Secondary outcome measures

Absolute change in LDL from baseline to follow up

Proportion of participants with LDL<100

Low-Density Lipoproteins

+1 more

ID-FH Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Motivational InterviewExperimental Treatment1 Intervention

Motivational interview arm will receive a message to schedule a follow up motivational interview via telephone or video after the baseline survey as well as follow up surveys.

Group II: Usual CareActive Control1 Intervention

Usual care arm will receive baseline and follow up surveys only.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

WHITESIDE Institute for Clinical ResearchUNKNOWN

Essentia HealthLead Sponsor

26 Previous Clinical Trials

108,010 Total Patients Enrolled

St. Luke's Hospital of DuluthOTHER

1 Previous Clinical Trials

2 Total Patients Enrolled

Media Library

Motivational interview Clinical Trial Eligibility Overview. Trial Name: NCT05238519 — Phase 3

High Cholesterol Research Study Groups: Usual Care, Motivational Interview

High Cholesterol Clinical Trial 2023: Motivational interview Highlights & Side Effects. Trial Name: NCT05238519 — Phase 3

Motivational interview 2023 Treatment Timeline for Medical Study. Trial Name: NCT05238519 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the main goals that we hope to achieve with this clinical trial?

"The primary aim of this study, which will last for 6 months post-intervention, is to increase knowledge about familial hypercholesterolemia. Additionally, the research team hopes to observe a change in the proportion of patients with LDL below 70 and 100, as well as an increase in self-reported genetic testing among participants."

Answered by AI

How many research subjects are included in this investigation?

"Yes, this is an active trial that is looking for 200 patients from 2 sites. The listing was first posted on February 15th, 2022 and updated the next day."

Answered by AI

Is there a danger in using Motivational interview (MI) with patients?

"Motivational interview (MI) received a score of 3 because there is evidence to support its efficacy and multiple rounds of data affirming its safety."

Answered by AI

How can I sign up for the research project?

"This study is admitting 200 participants with genetic disease between the ages of 2 and 75. Most importantly, candidates are required to meet the following criteria: Age 2-75 years, patients with existing clinical diagnosis or suspected FH, known genetic mutation of FH, patients currently taking a lipid-lowering medication and have an LDL >124 mg/dL or total cholesterol >195 mg/dL, capable of providing informed consent, Patients should reside in Minnesota, Wisconsin or North dakota., patients with an initial (pretreatment) LDL level >190 mg/dL or total cholesterol >300 mg/dL (age >19 years) or"

Answered by AI

Are geriatric patients welcome in this experiment?

"The age requirement for this study is that participants must be over 2 and under 75 years old."

Answered by AI

Are there any openings for volunteers in this experiment?

"Currently, this study is looking for patients that fit the bill. According to the clinicaltrials.gov website, the posting went up on February 15th, 2022 and was edited yesterday – on the 16th."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Improved Diagnosis of Familial Hypercholesterolemia Across the Northland (ID-FH)

2022. "Improved Diagnosis of Familial Hypercholesterolemia Across the Northland (ID-FH)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05238519.

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