Familial HypercholesterolemiaPhase 3ID-FHNCT05238519
Improved Diagnosis of Familial Hypercholesterolemia Across the Northland (ID-FH)
A Phase 3 study testing Motivational interview (MI) in people with Familial Hypercholesterolemia and Cholesterol, Elevated, run by Essentia Health at 2 sites in United States.
Trial summary
The overall goal of this study is to promote awareness of Familial Hypercholesterolemia (FH). The investigators aim to enroll patients with suspected FH into the study and will randomize them to receive usual care or motivational interview. Read more about this study
- Who is it for?
- Ages 2 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Familial Hypercholesterolemia, Cholesterol, Elevated, Genetic Disease
- What is being tested?
- Motivational interview (MI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 257 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Feb 2022to 21 Aug 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Aspirus St. Luke's Hospital
Duluth, Minnesota, 55805
Essentia Health
Duluth, Minnesota, 55805
About this study
The overall goal of this study is to promote awareness of Familial Hypercholesterolemia (FH). The investigators aim to enroll patients with suspected FH into the study and will randomize them to receive usual care or motivational interview. Primary study outcomes include knowledge of FH, as well as clinical and patient-reported outcomes. This study aims to promote optimal disease management and improve outcomes of FH patients.
Read the detailed description
This is a randomized 2-arm study designed to examine the impact of a personalized remote intervention that includes evidence-based risk communication and behavior change techniques with navigation. Patients who meet the inclusion criteria from both Essentia Health (Site A) and Aspirus St. Luke's Hospital (Site B) will be invited to complete the baseline survey. Participants will be randomized to one of two study arms: usual care (UC) and motivational interview (MI). Participant assignment occurs after completion of the baseline survey. Participants randomized to receive a MI will be contacted via telephone or email to schedule a date and time when they are available to receive a video or phone call from the study coordinator. During the MI, participants will be assessed on their readiness to communicate risk with family members. A letter will be sent to the participants physician for notice of the participation in the study. A follow-up survey will be sent to participants approximately 6 months after completion of the baseline survey, in both arms of the study. The study arms will be compared with regard to awareness and treatment of FH (aim 1), as well as the uptake of cascade screening in first- and second-degree relatives (aim 2).
- Being tested
- Motivational interview (MI)
- Keywords
- cholesterol, motivational interview, survey, cascade screening
- Medical subject headings
- Hyperlipoproteinemia Type II, Hypercholesterolemia, Genetic Diseases, Inborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interview (MI)Behavioural
The MI intervention is adapted from the CHEERS study intervention (M Health Fairview) found to be effective in promoting lipid screening in patients at increased risk for FH.
Within one month of completion of the baseline survey, a study coordinator, who received training in motivational interview integrity, will conduct a 20-40-minute (depending on participant needs) telephone or virtual (zoom) interview with participants randomized to this arm. Participants will be assessed on their readiness to get their cholesterol checked and discuss with family members the risk of FH.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interview | Experimental | 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. Receives: Behavioral: Motivational interview (MI) |
| Usual Care | No intervention | Usual care arm will receive baseline and follow up surveys only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge of familial hypercholesterolemia
Self-report of knowledge of personal history of FH will be assessed at baseline and follow up
Measured: 12 months post intervention
Cascade screening of 1st degree family members
Cascade screening will be assessed using self-report of either a) discussion about lipid screening with at least one first-degree relative or b) discussion about genetic testing for FH (in the patient's first-degree relatives) within 6 months of the intervention
Measured: 6 months post intervention
Secondary outcomes (4)
Proportion of participants with LDL<100
Percent change in proportion of participants with LDL<100 from pre-enrollment LDL-c to follow up.
Measured: 12 months post enrollment
Proportion of participants with LDL<70
Percent change in proportion of participants with LDL<70 from pre-enrollment LDL-c to follow up.
Measured: 12 months post enrollment
Absolute change in LDL from baseline to follow up
Compared absolute and percent lowering of LDL from pre-enrollment LDL-c to follow up.
Measured: 12 months post enrollment
Proportion of patients with self-report of genetic testing
Self-report of completion of a genetic test for familial hypercholesterolemia within 12 months of enrollment
Measured: 12 months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start15 Feb 2022
- Primary completion6 Nov 2024
- Study completion21 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A baseline survey will be sent to eligible participants age 2-75 years. Participants age 18-75 years who complete the survey will be randomly assigned to receive a motivational interview intervention or usual care. If an eligible patient is under the age of 18 years, they will not be eligible to receive a motivational interview. Therefore, the patient's parent or legal guardian will be the primary target for participation in the survey and will be asked to complete the survey from their own perspective. The patient's parent will be recognized as the "participant" in this study and will then be eligible for randomization to the MI arm. A follow up survey will be sent to all participants approximately 6 months after completion of the baseline survey.
- Masking
- None (open label)
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Essentia Health
- Sponsor type
- University, hospital or other
- Collaborators
- WHITESIDE Institute for Clinical Research, Aspirus St. Luke's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05238519
- Sponsor's protocol ID
- EH21700
- Acronym
- ID-FH
- Status last verified
- Sep 2026
- First submitted
- 3 Feb 2022
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Diagnosis of Familial Hypercholesterolemia Across the Northland (ID-FH)
- ClinicalTrials.gov ID
- NCT05238519
- Acronym / sponsor ID
- ID-FH / EH21700
- Keywords
- cholesterol, motivational interview, survey, cascade screening
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Essentia HealthUniversity, hospital or other
- Collaborators
- WHITESIDE Institute for Clinical Research, Aspirus St. Luke's Hospital
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 6 Nov 2024 (actual)
- Study completion
- 21 Aug 2025 (actual)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of this study is to promote awareness of Familial Hypercholesterolemia (FH). The investigators aim to enroll patients with suspected FH into the study and will randomize them to receive usual care or motivational interview. Primary study outcomes include knowledge of FH, as well as clinical and patient-reported outcomes. This study aims to promote optimal disease management and improve outcomes of FH patients.
Detailed description
This is a randomized 2-arm study designed to examine the impact of a personalized remote intervention that includes evidence-based risk communication and behavior change techniques with navigation. Patients who meet the inclusion criteria from both Essentia Health (Site A) and Aspirus St. Luke's Hospital (Site B) will be invited to complete the baseline survey. Participants will be randomized to one of two study arms: usual care (UC) and motivational interview (MI). Participant assignment occurs after completion of the baseline survey. Participants randomized to receive a MI will be contacted via telephone or email to schedule a date and time when they are available to receive a video or phone call from the study coordinator. During the MI, participants will be assessed on their readiness to communicate risk with family members. A letter will be sent to the participants physician for notice of the participation in the study. A follow-up survey will be sent to participants approximately 6 months after completion of the baseline survey, in both arms of the study. The study arms will be compared with regard to awareness and treatment of FH (aim 1), as well as the uptake of cascade screening in first- and second-degree relatives (aim 2).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A baseline survey will be sent to eligible participants age 2-75 years. Participants age 18-75 years who complete the survey will be randomly assigned to receive a motivational interview intervention or usual care. If an eligible patient is under the age of 18 years, they will not be eligible to receive a motivational interview. Therefore, the patient's parent or legal guardian will be the primary target for participation in the survey and will be asked to complete the survey from their own perspective. The patient's parent will be recognized as the "participant" in this study and will then be eligible for randomization to the MI arm. A follow up survey will be sent to all participants approximately 6 months after completion of the baseline survey.
| Arm | Type | Receives |
|---|---|---|
| Motivational Interview | Experimental | Behavioral: Motivational interview (MI)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. |
| Usual Care | No intervention | –Usual care arm will receive baseline and follow up surveys only. |
Who may qualify
- Ages
- 2 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational interview (MI)The MI intervention is adapted from the CHEERS study intervention (M Health Fairview) found to be effective in promoting lipid screening in patients at increased risk for FH. Within one month of completion of the baseline survey, a study coordinator, who received training in motivational interview integrity, will conduct a 20-40-minute (depending on participant needs) telephone or virtual (zoom) interview with participants randomized to this arm. Participants will be assessed on their readiness to get their cholesterol checked and discuss with family members the risk of FH. | Behavioural | Motivational Interview |
Primary outcome
Knowledge of familial hypercholesterolemia
Time frame: 12 months post intervention
Self-report of knowledge of personal history of FH will be assessed at baseline and follow up
Cascade screening of 1st degree family members
Time frame: 6 months post intervention
Cascade screening will be assessed using self-report of either a) discussion about lipid screening with at least one first-degree relative or b) discussion about genetic testing for FH (in the patient's first-degree relatives) within 6 months of the intervention
4 secondary outcomes
Proportion of participants with LDL<100
Time frame: 12 months post enrollment
Proportion of participants with LDL<70
Time frame: 12 months post enrollment
Absolute change in LDL from baseline to follow up
Time frame: 12 months post enrollment
Proportion of patients with self-report of genetic testing
Time frame: 12 months post enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Motivational interview (MI) in people with Familial Hypercholesterolemia and Cholesterol, Elevated, run by Essentia Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge of familial hypercholesterolemia (time frame: 12 months post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.