Motivational Interviewing for High Cholesterol

(ID-FH Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Essentia Health

Must be taking: Lipid-lowering

Disqualifiers: Pregnancy, Prisoners, Untreated hypothyroidism, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial aims to help patients with suspected Familial Hypercholesterolemia (FH) by using motivational interviews. These interviews educate patients about their health risks and encourage them to inform their family members. The goal is to improve disease management and early detection in relatives.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, it mentions that patients currently taking a lipid-lowering medication are eligible, so it seems likely you can continue your current treatment.

What data supports the effectiveness of the treatment Motivational Interviewing for High Cholesterol?

Research shows that motivational interviewing (MI) can help reduce total cholesterol and low-density-lipoprotein cholesterol levels, suggesting it may be effective for managing high cholesterol. MI is a counseling approach that encourages patients to talk about and make positive changes in their health behaviors. ^{1 2 3 4 5}

Is motivational interviewing safe for humans?

Motivational interviewing (MI) has been used safely in various studies for conditions like high cholesterol and obesity. It is a counseling method that helps people change their behavior and does not involve any physical interventions, making it generally safe for humans. ^{1 5 6 7 8}

How is the treatment Motivational Interviewing different from other treatments for high cholesterol?

Motivational Interviewing (MI) is unique because it focuses on enhancing a person's own motivation to change their lifestyle, such as diet and exercise, to improve cholesterol levels, rather than relying on medication. It involves a counseling approach that helps individuals resolve their ambivalence about making health-related changes, which can lead to better management of cholesterol without the use of drugs. ^{1 6 8 9 10}

Research Team

Eligibility Criteria

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.

Inclusion Criteria

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

I have or might have familial hypercholesterolemia (FH).

I am between 2 and 75 years old.

Exclusion Criteria

Lack of research authorization

Unable to provide informed consent (including non-English speaking individuals)

I have a condition like untreated thyroid issues or kidney problems that could be causing my high cholesterol.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Survey

Participants complete a baseline survey to assess initial knowledge and readiness

1 week

1 visit (virtual)

Intervention

Participants receive either usual care or a motivational interview to promote awareness and management of FH

6 months

1-2 visits (virtual)

Follow-up

Participants are monitored for changes in knowledge, LDL levels, and cascade screening uptake

12 months

1 visit (virtual)

Treatment Details

Interventions

• Motivational interview (Behavioral Intervention)

Trial Overview 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.

Participant Groups

Group I: Motivational Interview Experimental Treatment 1 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 Care Active Control 1 Intervention

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Aspirus St. Luke's Hospital Duluth, MN

St. Luke's Hospital Duluth, MN

Essentia Health Duluth, MN

Who Is Running the Clinical Trial?

Essentia Health

Lead Sponsor

Trials

27

Patients Recruited

107,000+

Aspirus St. Luke's Hospital

Collaborator

Trials

1

Patients Recruited

300+

WHITESIDE Institute for Clinical Research

Collaborator

Trials

1

Patients Recruited

300+

St. Luke's Hospital of Duluth

Collaborator

Trials

2

Patients Recruited

300+

Findings from Research

Motivational interviewing (MI) is an effective communication technique that helps patients engage in discussions about changing their health behaviors by addressing their ambivalence.

MI practitioners use specific skills and strategies to create a gap between a patient's current behaviors and their personal goals, facilitating a more productive conversation about health changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivating Behavioral Change. Tooley, EM., Kolahi, A.[2022]

A phone-based motivational interviewing (MoI) intervention significantly improved adherence to statin medications among patients, with the intervention group showing a mean proportion of days covered (PDC) of 0.67 compared to 0.55 in the control group (P < 0.001).

Patients receiving the MoI intervention were less likely to discontinue their statin therapy (odds ratio of 0.38) and had a higher likelihood of being adherent, indicating that tailored interventions based on past adherence patterns can effectively enhance medication compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing Statin Adherence Using a Motivational Interviewing Intervention and Past Adherence Trajectories in Patients with Suboptimal Adherence. Abughosh, SM., Vadhariya, A., Johnson, ML., et al.[2023]

A study involving 1742 participants at high risk for cardiovascular disease found that enhanced motivational interviewing (MI) combined with behavior change techniques did not significantly improve physical activity or weight loss compared to usual care over 24 months.

While there were some reductions in weight at the 12-month follow-up for both group and individual interventions, these interventions were not cost-effective and did not outperform usual care in the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced motivational interviewing for reducing weight and increasing physical activity in adults with high cardiovascular risk: the MOVE IT three-arm RCT. Ismail, K., Stahl, D., Bayley, A., et al.[2021]

The Web-based e-learning platform for brief motivational interviewing (MOTIV@CŒUR) was found to be feasible and highly acceptable among cardiovascular care nurses, with 77% completing the training within the designated time frame.

Post-training assessments showed a significant increase in nurses' self-reported clinical use of confidence interventions, indicating that the training effectively enhanced their perceived skills in brief motivational interviewing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Web-Based E-Learning Platform for Brief Motivational Interviewing by Nurses in Cardiovascular Care: A Pilot Study. Fontaine, G., Cossette, S., Heppell, S., et al.[2018]

This study will evaluate the effectiveness of Motivational Interviewing (MI) compared to standard brief advice in improving cholesterol levels and lifestyle changes in 436 patients with dyslipidemia, guided by 48-50 general practitioners across 35 primary care centers in Spain.

The trial aims to provide robust evidence on whether MI can lead to better lipid control and healthier behaviors over a 12-month period, focusing on key outcomes like cholesterol levels, cardiovascular risk, and adherence to treatment guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Motivational Interviewing in improving lipid level in patients with dyslipidemia assisted by general practitioners: Dislip-EM study protocol. Pérula, LA., Bosch, JM., Bóveda, J., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

The effects of motivational interviewing on physiological outcomes. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Motivating Behavioral Change. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Enhancing Statin Adherence Using a Motivational Interviewing Intervention and Past Adherence Trajectories in Patients with Suboptimal Adherence. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of motivational interviewing to improve chronic condition self-management: what does the research show us? [2019]

5. England pubmed.ncbi.nlm.nih.gov

Enhanced motivational interviewing for reducing weight and increasing physical activity in adults with high cardiovascular risk: the MOVE IT three-arm RCT. [2021]

6. Canada pubmed.ncbi.nlm.nih.gov

Evaluation of a Web-Based E-Learning Platform for Brief Motivational Interviewing by Nurses in Cardiovascular Care: A Pilot Study. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Randomized clinical trial comparing the effectiveness of two dietary interventions for patients with hyperlipidaemia. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Testing the effectiveness of motivational interviewing as a weight reduction strategy for obese cardiac patients: a pilot study. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Motivational Advising Workshop: Utilizing Motivational Interviewing Theory to Facilitate and Engage Intrinsic Motivation to Change Learners' Behavior. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Effectiveness of Motivational Interviewing in improving lipid level in patients with dyslipidemia assisted by general practitioners: Dislip-EM study protocol. [2021]