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Talking it out: study tests if a phone call can tame inherited high cholesterol

NCT ID NCT05238519

Knowledge-focused Sponsor: Essentia Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This study looks at whether a motivational interview—a 20-40 minute phone or video chat—can help people with familial hypercholesterolemia (FH) get their cholesterol checked and talk to family about screening. About 300 people with suspected or confirmed FH will be randomly assigned to usual care or the interview. The goal is to improve awareness and management of this genetic condition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
motivational interview
What this could lead to
If successful, this could show that a simple conversation helps more people get diagnosed and manage their cholesterol better.
What could go wrong
This is a behavioral study, not a drug trial, so it won't directly lower cholesterol. Results depend on people's willingness to change habits.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

257 people

The number who actually took part.

Started

Feb 2022

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 2-75 years * patients with existing clinical diagnosis or suspected FH * known genetic mutation of FH * patients with an initial (pretreatment) LDL level \>190 mg/dL or total cholesterol \>300 mg/dL (age \>19 years) or LDL-c \> 160mg/dL or total cholesterol \>260 mg/dL in children age 2-19 years * 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. Exclusion Criteria: * Lack of research authorization * unable to provide informed consent (including non-English speaking individuals) * known medical condition other than FH that is thought to contribute to hyperlipidemia (i.e., untreated hypothyroidism, nephrotic syndrome, cholestasis hypopituitarism) * Pregnant women and prisoners will also be excluded.

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Conditions

The condition(s) this trial relates to.

familial hypercholesterolemia hereditary disease Hypercholesterolemia hyperlipidemia Hyperlipoproteinemia Type II

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cholesterol, elevated Familial hypercholesterolemia Genetic disease

Contacts and locations

Locations

  • Aspirus St. Luke's Hospital

    Duluth, Minnesota, 55805, United States

  • Essentia Health

    Duluth, Minnesota, 55805, United States

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