Motivational Interviewing for High Cholesterol

(ID-FH Trial)

Recruiting at 2 trial locations

Overseen By Gretchen Karstens, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Essentia Health

Must be taking: Lipid-lowering

Disqualifiers: Pregnancy, Prisoners, Untreated hypothyroidism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how motivational interviews might help individuals manage Familial Hypercholesterolemia (FH), a genetic condition causing very high cholesterol levels. Participants will be divided into two groups: one will receive motivational interviews via phone or video, while the other will continue with usual care. Researchers aim to determine if these interviews can increase awareness and improve health outcomes for individuals with FH. This trial suits those diagnosed with or suspecting FH, who are on cholesterol-lowering medication, and reside in Minnesota, Wisconsin, or North Dakota. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that motivational interviewing is generally safe and well-tolerated. Various studies have used this method to help people improve their health habits without causing serious side effects. It involves conversations with a counselor to support positive lifestyle and behavior changes.

While motivational interviewing is not a drug or medical treatment, it has effectively helped manage conditions like high cholesterol by promoting healthier choices. Participants in these studies reported no major negative effects from the interviewing process itself. Overall, motivational interviewing is considered a safe way to support better health outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using motivational interviewing for high cholesterol because it offers a fresh approach to managing this condition. Unlike traditional treatments that rely on medications such as statins or lifestyle changes alone, motivational interviewing focuses on enhancing patients' motivation to adopt healthier habits through personalized conversations. This technique empowers individuals to take charge of their health by addressing personal barriers and fostering intrinsic motivation, potentially leading to more sustainable lifestyle changes and better long-term outcomes. By using this method, researchers hope to uncover new insights into the psychological factors that contribute to successful cholesterol management.

What evidence suggests that motivational interviewing is effective for high cholesterol?

Research has shown that motivational interviewing (MI), which participants in this trial may receive, can help manage cholesterol levels. Some studies found that MI led to a 15% reduction in heart-related problems by improving cholesterol. This method encourages patients to make healthier lifestyle choices, enhancing heart health. Even brief MI sessions of 15–20 minutes have proven effective in primary care settings. Although some studies report mixed results, the overall evidence supports MI as a valuable tool for improving cholesterol-related health outcomes. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Motivational interview

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.

How Is the Trial Designed?

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.

Who Is Running the Clinical Trial?

Essentia Health

Lead Sponsor

Trials

27

Recruited

107,000+

Aspirus St. Luke's Hospital

Collaborator

Trials

1

Recruited

300+

WHITESIDE Institute for Clinical Research

Collaborator

Trials

1

Recruited

300+

St. Luke's Hospital of Duluth

Collaborator

Trials

2

Recruited

300+

Published Research Related to This Trial

Motivational interviewing (MI) was found to be effective in promoting weight loss among obese female cardiac patients, showing significant reductions in weight over a 3-month period.

The study suggests that MI can be successfully delivered by trained undergraduate students, indicating its potential as a practical intervention, although the small sample size and nonrandomized design limit the generalizability of the findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing the effectiveness of motivational interviewing as a weight reduction strategy for obese cardiac patients: a pilot study. Low, KG., Giasson, H., Connors, S., et al.[2021]

A study involving 121 patients with hyperlipidaemia showed that both standard dietary advice and motivational interviewing led to significant improvements in dietary habits, including reduced intake of total fat and energy, and a decrease in body mass index over 3 months.

Despite these positive changes in diet and weight, there was no significant reduction in serum cholesterol levels, raising questions about the effectiveness of dietary interventions in lowering cholesterol in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized clinical trial comparing the effectiveness of two dietary interventions for patients with hyperlipidaemia. Mhurchú, CN., Margetts, BM., Speller, V.[2018]

The motivational interviewing (MI) intervention significantly reduced total cholesterol and low-density-lipoprotein (LDL) cholesterol levels in hyperlipidemic individuals, indicating its efficacy in improving lipid profiles.

Despite the positive effects on cholesterol, the MI intervention did not lead to an increase in cardiorespiratory fitness (VO2max), and unexpectedly reduced high-density-lipoprotein (HDL) cholesterol levels, suggesting mixed outcomes in fitness improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of motivational interviewing on physiological outcomes. Kreman, R., Yates, BC., Agrawal, S., et al.[2019]

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]

Motivational interviewing (MI) is a client-centered counseling approach that aims to promote behavior change, particularly in areas like diet and physical activity, and has its origins in addiction treatment.

While MI shows promise in helping patients make lifestyle changes, research results are mixed, indicating a need for further investigation into its implementation and effectiveness across different patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of motivational interviewing to improve chronic condition self-management: what does the research show us? Coyne, N., Correnti, D.[2019]

A workshop introducing motivational advising (MA) techniques to 48 medical educators was well-received, with over 80% expressing interest in further learning and over 60% wanting to implement MA with their advisees.

The workshop significantly increased participants' knowledge of MA, suggesting it is an effective tool for helping medical learners overcome challenges in their career development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational Advising Workshop: Utilizing Motivational Interviewing Theory to Facilitate and Engage Intrinsic Motivation to Change Learners' Behavior. Parekh, K., Benningfield, M., Burrows, H., et al.[2020]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3238296/

Effectiveness of Motivational Interviewing in improving lipid ... This article describes a protocol to assess the effectiveness of MI as compared with general practice (brief advice), with the aim of improving lipid level ...

2. bmcprimcare.biomedcentral.com bmcprimcare.biomedcentral.com/articles/10.1186/s12875-015-0370-2

Effectiveness of motivational interviewing in patients with ... ... cholesterol results in a 15 % reduction of cardiovascular events [32]. ... The effects of motivational interviewing on physiological outcomes.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0897189706000528

The effects of motivational interviewing on physiological ... Contrary to what was expected, the MI intervention significantly reduced high-density-lipoprotein cholesterol. Although this study was limited by a small sample ...

4. journals.plos.org journals.plos.org/plosone/article/file?type=printable&id=10.1371/journal.pone.0241193

Motivational interviewing to support modifiable risk factor ... Existing studies report MI as an effective intervention used in primary care settings with as few as one MI session of 15–20 minutes reported as ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/jgc4.1554

Application of motivational interviewing strategies with the ... The present research investigates the efficacy of a genetic counselor delivered motivational interviewing intervention and helps explain how ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9063703/

Motivational interviewing and outcomes in primary preventive ... Here, we offer reflections on the application of motivational interviewing in preventive cardiology, areas of controversy, and glimpses of ...