Implementation Strategies for Reducing Cardiovascular Risk in Serious Mental Illness

Recruiting 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

72 Participants Needed

Trial Summary

What is the purpose of this trial?

In this trial, the investigators will examine the uptake of the evidenced-based IDEAL Goals program, a heart disease risk reduction program, while testing different implementation strategies with our partners in Michigan and Maryland who serve persons with serious mental illness (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 data supports the effectiveness of this treatment for reducing cardiovascular risk in serious mental illness?

Research shows that people with serious mental illnesses have a higher risk of heart disease, and interventions like health behavior coaching and care coordination can help manage this risk. Programs that include weight management, smoking cessation, and managing conditions like high blood pressure and diabetes have shown promise in improving heart health in this population. ^{1 2 3 4 5}

Is the treatment generally safe for humans?

The research articles provided focus on the safety of antipsychotic medications, which are not directly related to the nonpharmacological interventions mentioned in the clinical trial. Therefore, there is no relevant safety information available for the treatment strategies like Coaching, Motivational Interviewing, or the IDEAL Goals program. ^{6 7 8 9 10}

How is the IDEAL Goals program treatment different from other treatments for reducing cardiovascular risk in serious mental illness?

The IDEAL Goals program is unique because it focuses on lifestyle interventions specifically adapted for people with serious mental illness, addressing factors like smoking, diet, physical activity, and blood pressure, which are often overlooked in this population. It emphasizes communication and collaboration among patients, carers, and healthcare providers to tailor the program to the specific needs of individuals with serious mental illness. ^{9 11 12 13 14}

Research Team

Gail Daumit, MD, MHS

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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 am 18 years old or older.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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 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]

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]

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]

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Scaling Evidence-Based Interventions to Improve the Cardiovascular Health of People With Serious Mental Illness. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Need for Cardiovascular Risk Reduction in Persons With Serious Mental Illness: Design of a Comprehensive Intervention. [2020]

3. Germany pubmed.ncbi.nlm.nih.gov

[Therapeutic options for weight management in schizophrenic patients treated with atypical antipsychotics]. [2008]

4. England 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. [2022]

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

Improving cardiovascular disease screening in community mental health centers. [2013]

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

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

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

Cardiovascular effects of psychotic illnesses and antipsychotic therapy. [2020]

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

Antipsychotic Cardiometabolic Side Effect Monitoring in a State Community Mental Health System. [2018]

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

Ideal Cardiovascular Health in Racially and Ethnically Diverse People with Serious Mental Illness. [2021]

10. Ireland pubmed.ncbi.nlm.nih.gov

Antipsychotics and cardiovascular risk: A case/non-case study. [2019]

11. England 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. [2020]

12. United States 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. [2022]

13. Switzerland 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. [2022]

14. Italy 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. [2022]