Behavioral Interventions for Cardiovascular Disease

(BETTER P2 Trial)

Overseen By Adina Lieberman

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Electronic portal account, previously contacted, others

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

Compensation: Varies

Number of Visits: Unknown

26242 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

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

What data supports the idea that Behavioral Interventions for Cardiovascular Disease is an effective treatment?

The available research shows that behavioral interventions, like message framing and financial incentives, can positively influence health behaviors. For example, message framing has been effective in improving self-management activities in patients with diabetes, which suggests it could also help those with cardiovascular disease. Additionally, financial incentives have been used successfully in trials to lower cholesterol levels, indicating potential benefits for heart health. These findings suggest that behavioral interventions can be a useful treatment for cardiovascular disease by encouraging healthier behaviors. ^{1 2 3 4 5}

What safety data exists for the behavioral interventions for cardiovascular disease?

The provided research does not directly address safety data for the behavioral interventions for cardiovascular disease or the specific treatments mentioned (Framing Method variations, Lynparza, AZD-2281, MK-7339, KU0059436). The studies focus on risk literacy, framing effects on cardiovascular risk, participant knowledge, and communication of trial results, but do not provide safety data for the interventions in question. ^{6 7 8 9 10}

Is the treatment in the trial 'Behavioral Interventions for Cardiovascular Disease' a promising treatment?

Yes, behavioral interventions are promising for treating cardiovascular disease. They help people change habits like exercise and diet, which can lower the risk of heart problems. These interventions use techniques like setting goals and self-monitoring, making it easier for people to stick to healthier lifestyles. ^{11 12 13 14 15}

What is the purpose of this trial?

Problem. Randomized clinical trials (RCTs) are the best way to determine if interventions are safe and effective. Usually only a small number of eligible patients enroll. This is because trials require people to consent to be enrolled and randomized. Black and Hispanic people are more likely to develop heart disease. They are also more likely to have risk factors for heart disease that are not controlled. Yet they are very under-represented in heart disease trials. This raises concerns about if trial results can be applied to the general population. Trial sponsors are required to enroll patients that reflect the racial and ethnic diversity of real-world people. Black and Hispanic people continue to enroll in trials at a lower rate. The goal of this study is to conduct a series of small randomized trials to test recruitment strategies to increase how many Black and Hispanic people enroll in heart disease clinical trials without diminishing trust. The investigators will test different recruitment strategies for participant enrollment in a few different areas. They will study the method of outreach, the way messages are framed, defaults, and enrollment incentives. They will run smaller recruitment strategy trials within larger parent trials (e.g. Penn Medicine Biobank cohort study). They will run a small recruitment strategy trial to test each approach and then include what they learned in the next small trial.

Eligibility Criteria

This trial is for Black and Hispanic individuals with active medical records at the participating site. It aims to improve diversity in cardiovascular disease studies by testing different recruitment strategies.

Inclusion Criteria

Your medical information must be available in the hospital's electronic system.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Recruitment Strategy Testing

Testing different recruitment strategies to increase enrollment of Black and Hispanic individuals in cardiovascular cohort studies

3 weeks

Follow-up

Participants are monitored for enrollment outcomes and trust in medical researchers

3 weeks

Treatment Details

Interventions

• Framing Method (Appeal to Altruism)
• Framing Method (Opt-Out)
• Framing Method (Social Proof or Perceived Scarcity)
• Incentive Structure
• Method of Contact
• Source of Contact

Trial Overview The study tests various methods to boost enrollment of under-represented groups in heart disease trials, including incentive structures, message framing (like social proof or scarcity), opt-out options, contact methods, and appeals to altruism.

Participant Groups

Group I: RCT #2, Arm #1: Source of Contact, Personal Clinic Active Control 1 Intervention

Potential participants in the parent trial will be randomized to receive a message inviting them to participate in the parent trial. The sender of the message will be the person's personal clinic.

Group II: RCT #3, Arm #2: Framing Method, Social Proof Active Control 1 Intervention

Potential participants in the parent trial will be randomized to receive a message inviting them to participate in the parent trial. The message will include language about social proof, i.e. information about participation of individuals similar to the person being contacted. For example, the message will include language such as: "Clinical research studies and the development of effective new medications would not have been possible without the participation of thousands of people like you".

Group III: RCT #3, Arm #3: Framing Method, No Appeal to Altruism, No Social Proof Active Control 1 Intervention

Potential participants in the parent trial will be randomized to receive a message inviting them to participate in the parent trial. The message will include no language about appeal to altruism or social proof.

Group IV: RCT #4, Arm #1: Incentive Structure, No Incentive Active Control 1 Intervention

Potential participants in the parent trial will be randomized to receive a message inviting them to participate in the parent trial. The message will have no language about incentives.

Group V: RCT #4, Arm #2: Incentive Structure, Guarantee Only Active Control 1 Intervention

Potential participants in the parent trial will be randomized to receive a message inviting them to participate in the parent trial. The message will state that, if the person decides to participate, they will receive $25.

Group VI: RCT #4, Arm #3: Incentive Structure, Guarantee + Small Lottery Active Control 1 Intervention

Potential participants in the parent trial will be randomized to receive a message inviting them to participate in the parent trial. The message will state that, if the person decides to participate, they will receive $15 and have a 1 in 20 chance to receive $200.

Group VII: RCT #4, Arm #4: Incentive Structure, Mid Lottery Only Active Control 1 Intervention

Potential participants in the parent trial will be randomized to receive a message inviting them to participate in the parent trial. The message will state that, if the person decides to participate, they will have a 1 in 20 chance to receive $500.

Group VIII: RCT #5, Arm #5: Incentive Structure, Large Lottery Only Active Control 1 Intervention

Potential participants in the parent trial will be randomized to receive a message inviting them to participate in the parent trial. The message will state that, if the person decides to participate, they will have a 1 in 100 chance to receive $2500.

Group IX: RCT #2, Arm #2: Source of Contact, Research Team Active Control 1 Intervention

Potential participants in the parent trial will be randomized to receive a message inviting them to participate in the parent trial. The sender of the message will be the research team.

Group X: RCT #3, Arm #1: Framing Method, Appeal to Altruism Active Control 1 Intervention

Potential participants in the parent trial will be randomized to receive a message inviting them to participate in the parent trial. The message will appeal to the person's altruism, for example: "Research studies like this one often do not include enough Black individuals. If Black people are not included in research like this, then doctors have less information about how cardiovascular disease might affect them and how new treatments could be used to improve their health. Your participation in this research can help doctors better understand how to treat members of your community in the future."

Group XI: RCT #1, Arm #1: Contact Method, Text Only Active Control 1 Intervention

Potential participants in the parent trial will be randomized to receive a message via text message. This message will invite them to participate in the parent trial.

Group XII: RCT #1, Arm #2: Contact Method, Email Only Active Control 1 Intervention

Potential participants in the parent trial will be randomized to receive a message via email. This message will invite them to participate in the parent trial.

Group XIII: RCT #1, Arm #3: Contact Method, Email+Text Active Control 1 Intervention

Potential participants in the parent trial will be randomized to receive a message via email and text message. This message will invite them to participate in the parent trial.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Findings from Research

The way clinical trial results are presented, such as using relative risk reduction or absolute risk reduction, can significantly influence physicians' perceptions and intended practices, with 12 studies highlighting this effect.

However, the impact of framing is highly variable and can be diminished by factors like the risk of harm, doctors' biases, and their clinical experience, indicating that while framing matters, it does not consistently dictate clinical decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of information framing on the practices of physicians. McGettigan, P., Sly, K., O'Connell, D., et al.[2019]

Patients participating in a study using financial incentives to lower LDL cholesterol reported positive experiences, with 65% noting personal health improvements and 61% experiencing increased health awareness.

The majority of patients (71%) found financial incentives motivating, and the intervention had little negative impact on their relationship with primary care physicians, suggesting that such approaches can be socially acceptable and effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' views of a behavioral intervention including financial incentives. Shea, JA., Adejare, A., Volpp, KG., et al.[2018]

Behavioral economics-based nudges significantly increased appointment scheduling rates for both Medicare wellness visits (13.0% vs. 9.7%) and Pap smears (2.9% vs. 1.6%) when compared to standard reminders, indicating that modifying communication can effectively enhance patient engagement.

The nudges also improved appointment completion rates for Pap smears (23.5% vs. 17.0%), while completion rates for Medicare wellness visits were similar between nudge and control groups, suggesting that the effectiveness of nudges may vary by type of preventive service.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Behavioral Economics-Based Messaging on Appointment Scheduling Through Patient Portals and Appointment Completion: Observational Study. Liang, SY., Stults, CD., Jones, VG., et al.[2022]

In a study involving 102 patients with type 2 diabetes, both positive and negative message framing significantly improved self-management activities and self-efficacy related to diabetes care over a 12-week period.

The negative message framing was found to be more effective than positive framing in enhancing self-management activities and self-efficacy, suggesting that threatening information can motivate better health behaviors in diabetic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Messaging Framing on the Self-Management Activities and Self-Efficacies of Patients with Type 2 Diabetes Mellitus. Bao, H.[2023]

In a study involving 902 patients with mild to moderate heart failure, adding self-management counseling to heart failure education did not significantly reduce the rates of death or hospitalization due to heart failure compared to education alone.

The trial, which followed patients for a median of 2.56 years, found no differences in secondary outcomes such as overall hospitalization rates or quality of life, suggesting that simply enhancing education with self-management strategies may not improve clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management counseling in patients with heart failure: the heart failure adherence and retention randomized behavioral trial. Powell, LH., Calvin, JE., Richardson, D., et al.[2022]

A study involving 192 second-year medical students showed that positive framing of a seminar on risk literacy significantly improved students' risk literacy scores compared to negative framing.

Both framing conditions reduced statistics anxiety, but the positive framing condition led to a greater increase in risk literacy, suggesting that how learning goals are presented can enhance educational outcomes in medical statistics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can positive expectations help to improve the learning of risk literacy? A cluster-randomized study in undergraduate medical students. Benson, S., Schmidt, K., Kleine-Borgmann, J., et al.[2022]

In a study involving 457 patients aged 60 to 79 with high blood pressure, presenting cardiovascular risk as either absolute risk (AR) or number needed to treat (NNT) did not significantly affect patient outcomes or the intensity of medication prescribing after 12 months.

Both formats resulted in similar levels of blood pressure control and prescribing practices, indicating that the way cardiovascular risk is framed in clinical guidelines does not impact the effectiveness of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial evaluating the framing of cardiovascular risk and its impact on blood pressure control [ISRCTN87597585]. Fahey, T., Montgomery, AA., Peters, TJ.[2019]

An infographic letter significantly improved participants' understanding of how dropouts can distort clinical trial conclusions, with about 90% of those who read the infographic correctly answering related questions compared to only two-thirds of the control group.

Participants who viewed the infographic also reported higher levels of trust, perceived transparency, and value for retention in the research organization, suggesting that such visual tools can enhance research literacy and potentially improve trial retention rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a methodological infographic on research participants' knowledge, transparency, and trust. Kiernan, M., Oppezzo, MA., Resnicow, K., et al.[2022]

A significant majority (88%) of participants in a trial about MRI access for knee issues expressed interest in receiving feedback on the study results, highlighting the ethical importance of communicating findings to research volunteers.

Among those who responded to a follow-up survey, 55% preferred a longer leaflet summarizing the trial results, valuing technical information and diagrams, which suggests that detailed communication may enhance participant engagement and understanding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participants' preference for type of leaflet used to feed back the results of a randomised trial: a survey. Brealey, S., Andronis, L., Dennis, L., et al.[2022]

A consensus study involving 24 experts led to the recommendation of 10 effective visualizations for presenting harm outcomes in clinical trial publications, enhancing clarity and understanding of trial results.

These visualizations, tailored to different types of outcomes, provide a more informative alternative to traditional frequency tables, helping researchers and clinicians better interpret harm data in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visualising harms in publications of randomised controlled trials: consensus and recommendations. Phillips, R., Cro, S., Wheeler, G., et al.[2023]

The Preventive Cardiology Center at UC San Diego focuses on training healthcare professionals in effective behavior change methods to reduce cardiovascular disease (CVD) risk, involving a comprehensive assessment of patients' physiological and behavioral factors.

Participants engage in a five-session group intervention that teaches various behavioral techniques, such as goal-setting and self-monitoring, to help them modify their dietary and exercise habits, ultimately aiming to lower their CVD risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A program for health behavior change in a preventive cardiology center. Sallis, JF., Criqui, MH., Kashani, IA., et al.[2007]

Health care providers (HCPs) are in a key position to promote physical activity (PA) as a way to prevent and treat cardiovascular disease (CVD), but many feel unprepared to tackle the challenges of encouraging behavior change.

Implementing behavioral counseling strategies can help HCPs effectively promote PA, which has the potential to significantly lower the incidence and progression of CVD in the population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting adherence to physical activity among individuals with cardiovascular disease using behavioral counseling: A theory and research-based primer for health care professionals. Williamson, TM., Moran, C., McLennan, A., et al.[2021]

A review of 984 articles identified 304 relevant studies on technology-enabled interventions for cardiovascular disease (CVD) prevention, highlighting the importance of using health behavior change techniques like self-monitoring and feedback, which were the most common techniques employed.

Over half of the intervention studies utilized established health behavior theories, with Social Cognitive Theory being the most frequently cited, suggesting that integrating these theories with various evidence-based techniques can enhance the effectiveness of CVD interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Behavior Change Techniques and Theory in Technologies for Cardiovascular Disease Prevention and Treatment in Adults: A Comprehensive Review. Winter, SJ., Sheats, JL., King, AC.[2022]

A systematic review of 22 studies involving 16,766 participants found that behavior change interventions for coronary heart disease (CHD) patients significantly reduced mortality risk (risk ratio = 0.82), although they did not lower the risk of CHD events.

The most commonly used behavior change techniques in these interventions were providing information and goal setting, but the specific components that contributed to the observed mortality reduction were not clearly identified.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can We Identify the Active Ingredients of Behaviour Change Interventions for Coronary Heart Disease Patients? A Systematic Review and Meta-Analysis. Goodwin, L., Ostuzzi, G., Khan, N., et al.[2022]

The nudge approach, which encourages healthier choices without heavy regulation, is gaining attention in public health but faces challenges due to misunderstandings about its scientific basis and ethical implications.

This article emphasizes the need for a nuanced understanding of how nudging can work alongside traditional regulations to effectively promote healthier behaviors and addresses the ethical considerations involved in implementing such strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Making Healthy Choices Easier: Regulation versus Nudging. Hansen, PG., Skov, LR., Skov, KL.[2017]

References

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

The effects of information framing on the practices of physicians. [2019]

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

Patients' views of a behavioral intervention including financial incentives. [2018]

3. Canada pubmed.ncbi.nlm.nih.gov

Effects of Behavioral Economics-Based Messaging on Appointment Scheduling Through Patient Portals and Appointment Completion: Observational Study. [2022]

4. Iran pubmed.ncbi.nlm.nih.gov

Effects of Messaging Framing on the Self-Management Activities and Self-Efficacies of Patients with Type 2 Diabetes Mellitus. [2023]

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

Self-management counseling in patients with heart failure: the heart failure adherence and retention randomized behavioral trial. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Can positive expectations help to improve the learning of risk literacy? A cluster-randomized study in undergraduate medical students. [2022]

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

Randomized trial evaluating the framing of cardiovascular risk and its impact on blood pressure control [ISRCTN87597585]. [2019]

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

Effects of a methodological infographic on research participants' knowledge, transparency, and trust. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Participants' preference for type of leaflet used to feed back the results of a randomised trial: a survey. [2022]

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

Visualising harms in publications of randomised controlled trials: consensus and recommendations. [2023]

11. Netherlands pubmed.ncbi.nlm.nih.gov

A program for health behavior change in a preventive cardiology center. [2007]

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

Promoting adherence to physical activity among individuals with cardiovascular disease using behavioral counseling: A theory and research-based primer for health care professionals. [2021]

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

The Use of Behavior Change Techniques and Theory in Technologies for Cardiovascular Disease Prevention and Treatment in Adults: A Comprehensive Review. [2022]

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

Can We Identify the Active Ingredients of Behaviour Change Interventions for Coronary Heart Disease Patients? A Systematic Review and Meta-Analysis. [2022]

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

Making Healthy Choices Easier: Regulation versus Nudging. [2017]