CAN-DO Program for Cardiovascular Risk

(Can-Do Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Martha Biddle

Disqualifiers: Under 60, Not in baseline

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

Compensation: Varies

Number of Visits: 20

Duration: 18 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how a special program, called CAN-DO, can reduce the risk of heart disease by focusing on better nutrition and self-care for older adults. The program includes 18 weekly group sessions on improving heart health and nutrition, in addition to the usual meals provided at community senior centers. It targets individuals aged 60 and older who already participate in meal programs at these centers. Participants from community dining sites with at least 20 members who speak English may be well-suited for this trial. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance heart health programs for seniors.

Do I have to stop taking my current medications for the trial?

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

What prior data suggests that this program is safe for older adults?

Research shows that programs aimed at reducing the risk of heart disease, such as the CAN-DO program, can be safe and effective. These programs often include activities like checking blood pressure, providing nutrition advice, and offering guidance on managing cholesterol levels.

Previous studies have shown that similar programs help people lower their cholesterol by about 26.5% and reduce their systolic blood pressure (the top number in a blood pressure reading) by 10.9%. These improvements are linked to fewer heart issues and better overall health.

No serious safety concerns have been reported with these types of programs. They mainly focus on lifestyle changes, which most people handle well. Participants might need to adjust their daily habits, but these changes are usually manageable and lead to better health.

Thus, joining a program like CAN-DO could be a safe way to lower the risk of heart disease while learning more about healthy living. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CAN-DO program because it offers a fresh approach to cardiovascular risk reduction by combining nutrition education with group support. Unlike typical treatments that focus on medication or individual dietary changes, this program integrates 18 weekly group education sessions that emphasize community and shared learning. Such a holistic and supportive approach could enhance adherence to lifestyle changes and significantly improve heart health outcomes. By focusing on education and community, CAN-DO aims to empower participants with the knowledge and support they need to make lasting health improvements.

What evidence suggests that the CAN-DO program is effective for reducing cardiovascular risk?

Research shows that programs focused on reducing heart disease risk can greatly improve health. Studies have found that combining different care strategies can enhance important heart health factors over time. For instance, one program aimed at lowering heart disease risk significantly reduced the chance of first-time heart problems within five years. Another study showed that using proven strategies together led to a 9.7% drop in heart disease risk for people at high risk. These findings suggest that the CAN-DO program, which participants in this trial will experience, can effectively lower heart disease risk through better eating habits and self-care practices. ^{2 6 7 8 9}

Who Is on the Research Team?

Martha Biddle, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for individuals aged 60 or older who speak English and regularly participate in meal programs at community dining sites with at least 20 members. It's designed to help them reduce their risk of cardiovascular disease through improved nutrition and self-management.

Inclusion Criteria

My dining site serves 20 or more people in a meal program.

I am 60 years old or older.

I am registered in a community meal program.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 18 weekly group education sessions related to CVD risk reduction and nutrition

18 weeks

18 visits (in-person)

Intermediate Feasibility Assessment

Assessment of health outcomes and feasibility at 18 weeks

1 week

1 visit (in-person)

Long-term Feasibility Assessment

Evaluation of long-term feasibility and health outcomes at 30 weeks

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CAN-DO

Trial Overview The CAN-DO program is being tested for its effectiveness in reducing the risk of cardiovascular diseases among older adults by promoting better nutritional habits and chronic condition management within community senior centers.

How Is the Trial Designed?

Group I: CAN DO Experimental Treatment 1 Intervention

usual programing offered as part of the congregate meal program plus 18 weekly group education sessions related to CVD risk reduction and nutrition.

Who Is Running the Clinical Trial?

Martha Biddle

Lead Sponsor

Trials

3

Recruited

180+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8020477/

Results of a prospective cardiovascular disease prevention ... Experts agree that TLC can reduce CVD risk but the incorporation of preventive strategies into practice remains a formidable challenge (David, 2002, Ebrahim et ...

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCOUTCOMES.121.007908

Reducing Cardiovascular Risk in the Medicare Million ... Combining all 3 evidence-based reductions resulted in a 9.7% (±3.6) lower ASCVD risk among high-risk patients, with 67 (27.0%) of practices ...

3. jamanetwork.com jamanetwork.com/journals/jama-health-forum/fullarticle/2820779

Scaling the CMS Cardiovascular Risk Reduction Model The final evaluation showed that the model reduced the absolute probability of a first-time CVD event within 5 years by 0.3 percentage points ( ...

4. bmcprimcare.biomedcentral.com bmcprimcare.biomedcentral.com/articles/10.1186/s12875-023-02010-y

Cardiovascular risk reduction with integrated care: results of 8 ... In patients participating in an integrated cardiovascular risk management program, we saw annual improvements in 3 important cardiovascular risk ...

5. chti.upenn.edu chti.upenn.edu/ascvd-risk-reduction-initiative

ASCVD Risk Reduction Initiative The ASCVD Risk Reduction Initiative is developing and evaluating a scalable heart disease prevention program that reduces modifiable ASCVD risk.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK554923/

Cardiovascular disease: risk assessment and reduction ... QRISK2 is currently integrated into electronic clinical systems so 10-year CVD risk assessments can be generated using data already available in ...

7. cms.gov cms.gov/priorities/innovation/innovation-models/million-hearts-cvdrrm

Million Hearts: Cardiovascular Disease Risk Reduction ... The Million Hearts CVD Risk Reduction Model supported prevention of CVD, improved health outcomes, and health care cost savings.

8. chibe.upenn.edu chibe.upenn.edu/program/the-ascvd-initiative/

The ASCVD Risk Reduction Initiative The program offers blood pressure monitoring and management, cholesterol counseling and medications, healthy eating resources including a custom video series on ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0828282X24003441

What Guidelines Say About Risk Reduction: Major Data on ... All guidelines base treatment decisions in primary prevention using an estimated CV risk, while also incorporating additional factors such as LDL-C levels and ...