Implementation Strategies for Reducing Cardiovascular Risk in Serious Mental Illness

Enrolling by invitation at 1 trial location

Overseen By Joseph Gennusa, PhD, RDN, LDN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Serious mental illness, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the IDEAL Goals program, designed to reduce heart disease risk in people with serious mental illness (SMI). Researchers are evaluating the program's effectiveness using various strategies, such as coaching or facilitation, in community mental health settings in Michigan and Maryland. Those working at a community mental health program and willing to participate in training and program delivery may be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could significantly benefit individuals with SMI.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the IDEAL Goals program and its implementation strategies are safe for individuals with serious mental illness?

Research has shown that programs like health coaching and extra support are generally safe for people with serious mental illnesses. These programs aim to improve heart health, which is crucial because this group faces a higher risk for heart disease.

Participants in similar programs have experienced positive results with few side effects. For instance, health coaching has helped individuals manage their heart health without major safety concerns. Similarly, support methods have not shown any major safety issues in other studies.

Overall, these strategies are designed to safely and effectively support heart health in people with serious mental illnesses. While no treatment is entirely without risk, evidence suggests these programs are safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the IDEAL Goals program because it aims to reduce cardiovascular risk specifically for individuals with serious mental illness, a group often underserved by current heart health strategies. Traditional treatments for cardiovascular issues typically focus on lifestyle changes and medications, but this program introduces a tailored approach through the Replicating Effective Programs (REP) model. What's unique is the added layer of support: some participants receive additional coaching, facilitation, or both, which can enhance the effectiveness of standard interventions by providing personalized guidance and motivation. This holistic approach could lead to better health outcomes by addressing both the physical and mental health needs of patients.

What evidence suggests that this trial's treatments could be effective for reducing cardiovascular risk in serious mental illness?

Research has shown that people with serious mental illnesses (SMI) are more likely to develop heart disease. The IDEAL Goals program, tested in this trial, is a proven method to help reduce heart disease risk in this group. Participants in different trial arms will receive various interventions. Some will receive the Replicating Effective Programs (REP) alone, while others will receive REP plus coaching, facilitation, or both. Studies have shown that health and wellness coaching can improve health for people with long-term illnesses, including those with SMI. Additionally, strategies that include behavioral counseling have effectively reduced heart disease risk. The IDEAL Goals program employs these methods to improve heart health in people with SMI, aiming to lower their risk of heart disease. ^{1 4 6 7 8}

Who Is on the Research Team?

Gail Daumit, MD, MHS

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 18 or older who are willing to participate in data collection and engage with the IDEAL Goals program, which aims to reduce heart disease risk among those with serious mental illness.

Inclusion Criteria

Must be English speaking

Agree to complete applicable data collection

I agree to participate and follow the program's requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of the IDEAL Goals program with different strategies to reduce heart disease risk among persons with serious mental illness

18 months

Follow-up

Participants are monitored for cardiovascular health outcomes and program uptake

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Coaching
• Facilitation
• IDEAL Goals program
• Replicating Effective Programs

Trial Overview The study tests how well different strategies help implement the IDEAL Goals program—a proven heart health initiative—in Michigan and Maryland communities serving individuals with serious mental illness.

How Is the Trial Designed?

Group I: Replicating Effective Programs (REP) plus facilitation Experimental Treatment 2 Interventions

Group II: Replicating Effective Programs (REP) plus coaching and facilitation Experimental Treatment 3 Interventions

Group III: Replicating Effective Programs (REP) plus coaching Experimental Treatment 2 Interventions

Group IV: Replicating Effective Programs (REP) Active Control 1 Intervention

IDEAL Goals program is already approved in United States for the following indications:

Approved in United States as IDEAL Goals program for:

• Heart disease risk reduction

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

The Well-being Support Programme, which monitored the physical health of 966 outpatients with severe mental illness over 2 years, led to significant improvements in physical activity, smoking cessation, and diet, indicating its efficacy in reducing cardiovascular risk.

Despite improvements in lifestyle factors, many participants still had significant cardiovascular risk factors at the end of the program, highlighting the ongoing need for accessible health interventions for individuals with severe mental illness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A well-being programme in severe mental illness. Reducing risk for physical ill-health: a post-programme service evaluation at 2 years. Smith, S., Yeomans, D., Bushe, CJ., et al.[2020]

A study analyzing 197 reported cases of cardiovascular adverse reactions to antipsychotic drugs found a significant increased risk, with an odds ratio of 2.3, indicating that patients on these medications are more likely to experience cardiovascular issues compared to those on other drugs.

Both typical and atypical antipsychotics showed similar levels of risk for serious heart conditions, particularly torsade de pointes and sudden death, suggesting that these medications may pose a greater cardiovascular risk than previously understood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antipsychotics and cardiovascular risk: A case/non-case study. Arias, LHM., Fadrique, RS., García, SP., et al.[2019]

People with serious mental illnesses (SMIs) face higher mortality rates due to cardiovascular disease (CVD), but effective interventions exist that can improve their cardiovascular health, although these are not widely implemented in clinical practice.

The Johns Hopkins ALACRITY Center is developing tailored implementation strategies for three evidence-based interventions targeting weight loss, smoking cessation, and management of hypertension and diabetes in people with SMI, aiming to enhance the uptake of these interventions in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scaling Evidence-Based Interventions to Improve the Cardiovascular Health of People With Serious Mental Illness. Yuan, CT., McGinty, EE., Dalcin, A., et al.[2023]

People with severe mental illness (SMI) have a higher prevalence of physical disorders, but screening and management of these health issues are often inadequate, even in developed countries.

Psychiatrists can significantly improve the physical health of SMI patients by monitoring and treating physical health parameters, as well as educating patients on lifestyle changes, which can lead to better overall health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical illness in patients with severe mental disorders. II. Barriers to care, monitoring and treatment guidelines, plus recommendations at the system and individual level. De Hert, M., Cohen, D., Bobes, J., et al.[2022]

A qualitative study involving 107 participants from various groups highlighted the need for improved communication and collaboration among patients, caregivers, and healthcare providers to enhance cardiovascular health in people with severe mental illness (PSMI).

The study identified key themes such as the need for better information, training, and support, which will inform the development of a cardiovascular risk prevention program tailored to the specific needs of PSMI, with practical interventions to be tested in a feasibility study starting in September 2022.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of a Qualitative Study Aimed at Building a Programme to Reduce Cardiovascular Risk in People with Severe Mental Illness. Costa, M., Meunier-Beillard, N., Guillermet, E., et al.[2022]

Lifestyle interventions targeting obesity and cardiometabolic risk factors have shown promise in the general population, but they need to be tailored for individuals with serious mental illness to be effective.

Successful interventions should include multiple components, personalization, longer duration, and frequent contact with trained providers, as these factors have been linked to better outcomes in the general population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A meta-review of lifestyle interventions for cardiovascular risk factors in the general medical population: lessons for individuals with serious mental illness. Ward, MC., White, DT., Druss, BG.[2022]

In a study of 314 participants with serious mental illness (SMI), the average ideal cardiovascular health (ICVH) score was 3.15 out of 8, indicating a need for improved cardiovascular health among this population.

Higher ICVH scores were linked to a history of cancer and better cardiorespiratory fitness, while lower scores were associated with female gender, racial/ethnic minority status, and antipsychotic medication use, highlighting the need for targeted health interventions for these groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ideal Cardiovascular Health in Racially and Ethnically Diverse People with Serious Mental Illness. Hawes, MR., Roth, KB., Wang, X., et al.[2021]

Effective antipsychotic treatment requires balancing efficacy with tolerability and safety, as minimizing adverse effects can enhance mental health outcomes and improve treatment adherence.

Psychiatric care providers should take an active role in managing cardiovascular health risks associated with antipsychotic medications, including careful medication selection and routine monitoring for cardiovascular risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Balancing efficacy and safety in treatment with antipsychotics. Correll, CU.[2019]

A health promotion program aimed at improving cardiovascular risk management for individuals with severe mental illness was developed with input from patients, caregivers, and health professionals, emphasizing self-determination and control over their health.

The program's feasibility was assessed in a multicenter qualitative study, and its effectiveness will be further evaluated in a randomized controlled trial, indicating a structured approach to enhancing health services for this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A collaboration between service users and professionals for the development and evaluation of a new program for cardiovascular risk management in persons with a diagnosis of severe mental illness: French multicenter qualitative and feasibility studies. Baleige, A., Besnard, JF., Meunier-Beillard, N., et al.[2022]

A study involving 130 patient records at a community mental health center demonstrated significant improvements in cardiovascular disease (CVD) screening processes after implementing new monitoring tools and educational interventions (p < .001).

The findings suggest that advanced practice registered nurses can effectively design and implement enhanced CVD screening methods, which may help reduce the high rates of morbidity and mortality associated with cardiovascular disease in seriously mentally ill patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving cardiovascular disease screening in community mental health centers. Maki, M., Bjorklund, P.[2013]

Individuals with schizophrenia face a higher risk of cardiovascular disease due to both the disorder itself and the side effects of antipsychotic medications, which can lead to cardiac autonomic dysfunction and metabolic syndrome.

While newer antipsychotics have a lower risk of causing arrhythmias, they may still increase cardiac death rates by negatively impacting metabolic health, highlighting the need for careful cardiovascular risk management in patients with serious mental illnesses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular effects of psychotic illnesses and antipsychotic therapy. Howell, S., Yarovova, E., Khwanda, A., et al.[2020]

A review of 2500 articles highlights that while atypical antipsychotics, especially clozapine, are effective for treating schizophrenia, they significantly increase the risk of weight gain and cardiovascular issues, which can reduce life expectancy.

There is a need for better clinical guidelines to monitor cardiovascular risk factors in patients on these medications, and structured weight-management programs that include diet and exercise have shown promise in preventing weight gain and metabolic changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Therapeutic options for weight management in schizophrenic patients treated with atypical antipsychotics]. Cordes, J., Sinha-Röder, A., Kahl, KG., et al.[2008]

A study evaluated the effectiveness of education and audit feedback to improve cardiometabolic monitoring in a state mental health system, focusing on patients on antipsychotic medications.

While some mental health centers showed improvement in monitoring rates for cholesterol, glucose, and other metrics, overall monitoring across the state did not significantly increase, suggesting that more intensive interventions may be necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antipsychotic Cardiometabolic Side Effect Monitoring in a State Community Mental Health System. Cotes, RO., de Nesnera, A., Kelly, M., et al.[2018]

Individuals with serious mental illness (SMI) face a significantly higher risk of cardiovascular disease (CVD), with mortality rates at least double that of the general US population, highlighting the urgent need for effective interventions.

An innovative 18-month randomized clinical trial is being conducted to test a comprehensive intervention that includes health behavior coaching and care management to reduce CVD risk factors in SMI patients, which could lead to improved physical health outcomes if successful.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Need for Cardiovascular Risk Reduction in Persons With Serious Mental Illness: Design of a Comprehensive Intervention. Dalcin, AT., Jerome, GJ., Appel, LJ., et al.[2020]

Citations

1. withpower.com withpower.com/trial/phase-cardiovascular-risk-10-2024-ce566

Implementation Strategies for Reducing Cardiovascular ... Research shows that people with serious mental illnesses have a higher risk of heart disease, and interventions like health behavior coaching and care ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7384647/

Health and wellness coaching positively impacts ... To date, health coaching research demonstrates positive effects on health outcomes for participants with various chronic diseases such as ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12551291/

study protocol for a cluster-randomized hybrid Type 3 ... IDEAL Goals is an empirically supported, cardiovascular risk reduction program tailored for people with serious mental illness (i.e., “clients”) ...

4. pcori.org pcori.org/research-results/2017/does-motivational-interviewing-plus-cognitive-behavioral-therapy-reduce-opioid-use-among-adults-chronic-pain-better-shared-decision-making-inspire-study

The INSPIRE Study Effectiveness of motivational interviewing plus cognitive behavioral therapy versus shared decision making for voluntary opioid tapering in ...

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0236734

Health and wellness coaching positively impacts individuals ... Health and wellness coaching (HWC) interventions have been reported to improve health outcomes for individuals with chronic diseases such as ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41131632/

Achieving cardiovascular health equity in community mental ... In this trial, we use Replicating Effective Programs (REP) as the foundational implementation strategy to test the effects of two additional ...

7. researchgate.net researchgate.net/publication/396841611_Achieving_cardiovascular_health_equity_in_community_mental_health_study_protocol_for_a_cluster-randomized_hybrid_Type_3_effectiveness-implementation_trial

study protocol for a cluster-randomized hybrid Type 3 ... Background People with serious mental illness die 10–20 years earlier than the overall population, mainly from cardiovascular disease.

8. europepmc.org europepmc.org/article/pmc/8855048

Scaling Evidence-Based Interventions to Improve the ... Cardiovascular disease (CVD) is the primary cause of preventable death for people with serious mental illnesses (SMIs) (1), due in large part to elevated rates ...