DECIDE + Community Health Worker Support for Cardiovascular Disease

Overseen By Gladys Thomas, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Outside age range, No CVD, others

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

Compensation: Varies

Number of Visits: 9

Duration: 18 weeks

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to help people in Philadelphia better manage heart-related conditions. It combines a group program called DECIDE, which supports decision-making, with assistance from community health workers (CHWs) to improve health habits and address social needs like housing and food security. Individuals with conditions such as diabetes, high blood pressure, or high cholesterol, who also face challenges like finding stable housing or accessing healthy food, might be suitable candidates. The study aims to determine if this program can help participants better manage their health and enhance their overall well-being. As an unphased trial, it offers participants the chance to contribute to innovative solutions for managing heart-related conditions and improving community health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

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

Research has shown that community-based programs like the DECIDE program are generally safe and well-received. Many studies have found that these programs help people better understand and manage heart disease without causing major side effects. For instance, digital tools for heart health have been linked to nearly a 40% reduction in heart-related issues. This indicates that such programs are helpful and usually safe for participants.

While specific information on side effects for the DECIDE program is not available, it is important to note that it is based on well-established community health worker models. These models emphasize education and support rather than medication or surgery, which typically means fewer risks. Participants can expect a supportive environment that enhances their health management skills and meets social needs, without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the DECIDE intervention for cardiovascular disease (CVD) because it combines group-based learning and community health worker (CHW) support, emphasizing the power of peer support and observational learning. Unlike traditional treatments that may focus solely on medication, DECIDE aims to enhance patients' self-management skills and confidence in managing their condition. This approach could lead to a more holistic and sustainable adoption of heart-healthy behaviors, potentially transforming how individuals manage CVD in their daily lives. By integrating regular follow-up calls, either biweekly or monthly, the intervention ensures continuous support and personalized guidance, which might be more engaging and effective than standard care options.

What evidence suggests that this trial's treatments could be effective for cardiovascular disease?

Studies have shown that community-based programs can greatly enhance understanding and management of heart and blood vessel diseases. This trial assigns participants to different arms to evaluate the effectiveness of the DECIDE program and Community Health Worker (CHW) support. Research indicates that the DECIDE program, which teaches health management and problem-solving, can improve skills in handling these diseases. This approach boosts confidence in health management and encourages healthier habits. A detailed review found that digital health programs, like DECIDE, can reduce the risk of heart disease by nearly 40%. These findings suggest that the DECIDE program may effectively improve skills for managing heart disease, especially with support from community health workers. ^{1 3 6 7 8}

Who Is on the Research Team?

Stephen Bonett, RN, PhD

Principal Investigator

University of Pennsylvania

Ashley Clemmons

Principal Investigator

Office of Community Empowerment and Opportunity

Jose Bauermeister, MPH, PhD

Principal Investigator

University of Pennsylvania

Antonia Villarruel, RN, PhD

Principal Investigator

University of Pennsylvania

Carmen Alvarez, RN, PhD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for Philadelphia residents aged 35-75 with cardiovascular risk factors like hypertension, pre-diabetes, diabetes, high cholesterol or a BMI of 30 or more. They must have unmet social needs such as housing stability and food security and have seen a CEO CHW.

Inclusion Criteria

I live in Philadelphia.

I have had my first visit with a CEO CHW.

I have a stable place to live.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the DECIDE+ intervention, consisting of 9 bi-weekly group sessions and alternating CHW consultations

18 weeks

9 group sessions (in-person), bi-weekly CHW consultations (virtual or in-person)

Follow-up

Participants are monitored for CVD self-management skills and resolution of social needs

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Community Health Worker Support
• DECIDE

Trial Overview The study tests an enhanced community health worker program combining DECIDE self-management sessions with regular CHW consultations against standard CHW services to improve cardiovascular disease management in underserved populations.

How Is the Trial Designed?

Group I: DECIDE+ Arm with a Monthly Follow-up Call Experimental Treatment 2 Interventions

We will offer the DECIDE intervention as a group-based program. This program, facilitated by CHWs, will emphasize the importance of observational learning and group support to strengthen their CVD problem solving. Consistent with the DECIDE intervention's existing evidence-base, CVD problem solving is hypothesized to strengthen an individual's CVD self-management self-efficacy and skills, respectively. Increased self-management self-efficacy and skills are posited to increase the adoption of CVD-related health promotive behaviors. Participants in this arm will also receive 1 follow-up call per month from their assigned CHW.

Group II: DECIDE+ Arm with Biweekly Follow-up Calls Experimental Treatment 2 Interventions

We will offer the DECIDE intervention as a group-based program. This program, facilitated by CHWs, will emphasize the importance of observational learning and group support to strengthen their CVD problem solving. Consistent with the DECIDE intervention's existing evidence-base, CVD problem solving is hypothesized to strengthen an individual's CVD self-management self-efficacy and skills, respectively. Increased self-management self-efficacy and skills are posited to increase the adoption of CVD-related health promotive behaviors. Participants in this arm will also receive 2 follow-up calls per month from their assigned CHW.

Group III: CHW Standard of Care with Biweekly Follow-up Calls Active Control 1 Intervention

CHWs currently serve Philadelphia residents by offering a wide range of personalized services aimed at improving their well-being. CHWs act as a crucial link between communities and healthcare providers, helping residents navigate the healthcare system. By offering guidance and social assistance, they improve community members' ability to communicate effectively with healthcare professionals. They also deliver health education that is culturally and linguistically appropriate, advocate for the health of individuals and communities, coordinate care through referrals and follow-up services, and assist eligible individuals in enrolling in federal, state, local, or nonprofit health and human services programs. Participants in this arm will receive a biweekly CHW Follow-up call.

Group IV: CHW Standard of Care with Monthy Follow-up Calls Active Control 1 Intervention

CHWs currently serve Philadelphia residents by offering a wide range of personalized services aimed at improving their well-being. CHWs act as a crucial link between communities and healthcare providers, helping residents navigate the healthcare system. By offering guidance and social assistance, they improve community members' ability to communicate effectively with healthcare professionals. They also deliver health education that is culturally and linguistically appropriate, advocate for the health of individuals and communities, coordinate care through referrals and follow-up services, and assist eligible individuals in enrolling in federal, state, local, or nonprofit health and human services programs. Participants in this arm will receive a Monthly CHW Follow-up call.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Westat

Collaborator

Trials

49

Recruited

39,700+

City of Phladelphia - Office of Community Empowerment and Opportunity

Collaborator

Trials

1

Recruited

500+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4551455/

Digital Health Interventions for the Prevention of ... In this systematic review and meta-analysis, we note a nearly 40% relative risk reduction in CVD outcomes with DHI, with particular impact on secondary CVD ...

2. ahajournals.org ahajournals.org/doi/10.1161/JAHA.124.039204

An Individual‐Based Cardiometabolic Policy Simulation Ischemic Heart Disease. The FDC intervention resulted in a 2.3% (95% UI, 1.7%–2.8%) annual reduction in IHD DALYs, compared with 0.55% ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666667722000253

Type and effectiveness of community-based interventions ... Overall, most studies showed that CBIs significantly improved knowledge related to CVDs. Conclusion: Community-based CVD preventive interventions are effective ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06871514

Effectiveness of Decision Support for Cardiovascular Risk ... This study aims to improve the way patients with cardiovascular diseases are informed about their treatment options. It explores methods to support shared ...

5. academic.oup.com academic.oup.com/eurheartj/article/45/12/998/7578334

Cardiovascular disease risk communication and prevention The primary outcome was the accuracy of risk perception. Secondary outcomes were clinician-reported changes in CVD risk, psychological responses ...

6. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001349

Implementation of Evidence-Based Behavioral ... Systematic review and meta-analysis of church-based interventions to improve cardiovascular disease risk factors. Am J Med Sci. 2023;366:199 ...

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2788645

Effect of Clinical Decision Support at Community Health ... In ITT results, total CVD risk did not improve significantly more in patients in intervention clinics overall but improved more among patients ...

8. nature.com nature.com/articles/s41746-020-00325-z

A digital health intervention for cardiovascular disease ... Primary outcome was adherence to guideline-recommended medications (≥80% of days covered for blood pressure (BP) and statin medications).