Non-Physician Health Worker Support for Metabolic Syndrome

(SIP Trial)

Overseen By Dipika Desai, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sonia Anand

Disqualifiers: Coronary artery disease, Stroke, Pregnancy, others

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

Compensation: Varies

Number of Visits: 5

Duration: 12 months

137 Participants Needed

Trial Summary

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 study team or your doctor.

What data supports the effectiveness of the treatment Non-Physician Health Worker for Metabolic Syndrome?

Research shows that non-physician health workers can help people stick to their medication and healthy habits after heart problems, which might also help with managing metabolic syndrome. ^{1 2 3 4 5}

Is it safe to use non-physician health workers for health interventions?

Research on non-physician health workers, such as those improving medication adherence after heart issues, suggests they are generally safe to use in health interventions. No specific safety concerns have been reported in these studies. ^{1 2 3 5 6}

How does the Non-Physician Health Worker treatment for metabolic syndrome differ from other treatments?

This treatment is unique because it involves support from non-physician health workers, who help patients stick to their medication and maintain a healthy lifestyle, rather than relying solely on medical interventions. This approach focuses on personalized support and education, which can be more accessible and relatable for patients. ^{1 7 8 9 10}

What is the purpose of this trial?

This study is a substudy of the Strenghtening Community Roots (SCORE!) Cohort study. The investigators will look for people, enrolled in the SCORE! Cohort study, with abnormal results related to blood sugar and fat, as well as high blood pressure and heart disease risks. The investigaors will try to help the community improve sugar, fat and blood pressure through trained people who are not necessarily a medical doctor but have health-sciences-training backgrounds. These people are called Non-Physician Health Workers (NPHW), and they will be under the direction of a medical doctor and will be also in close communication with the participants and the medical doctor to improve their health. This will happen through a total of 12 months, having online and on-site visits, for follow-up.

Research Team

Sonia Anand, MD, PhD

Principal Investigator

McMaster University

Lita Cameron, MD, MSc

Principal Investigator

McMaster University

Eligibility Criteria

This trial is for individuals already part of the SCORE! Cohort study with issues like high blood sugar, bad cholesterol levels, and high blood pressure. They should be at risk for heart disease but don't need to have a medical background. The key is they haven't been excluded from the main SCORE! study.

Inclusion Criteria

Participants will be identified from the SCORE! Cohort study who have previously received a letter indicating their cardiovascular risk score

Uncontrolled CV risk factors defined as: Blood pressure measurements: systolic ≥ 140 or diastolic BP ≥ 90 mm Hg; Non-HDL cholesterol > 2.66 mmol/L; Random plasma glucose of ≥ 11.1 mmol/L or HbA1c% ≥ 6.5%

Exclusion Criteria

Involvement in another study or program that would interfere with the study protocol

Pregnancy or plans to become pregnant within 12 months

Other serious conditions or logistic factors likely to interfere with study participation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive guidance from Non-Physician Health Workers (NPHW) to improve cardiovascular health through lifestyle changes and medical referrals

12 months

Online and on-site visits

Follow-up

Participants are monitored for changes in cardiovascular risk factors and adherence to recommendations

12 months

5 follow-up visits

Treatment Details

Interventions

• Non-Physician Health Worker

Trial Overview The trial tests if health workers without a medical degree can help improve participants' health over 12 months. These workers are trained in health sciences and work under a doctor's supervision, using online and on-site visits to manage conditions like diabetes and high cholesterol.

Participant Groups

Group I: Implementation group. Experimental Treatment 1 Intervention

The study is based on the HOPE-4 protocol, where trained individuals will support participants in adhering to healthy lifestyle recommendations and support their access to a family physician to follow up on care recommendations. The NPHWs will be allied health professionals (e.g., pharmacists, internationally trained physicians, physiotherapists, nurses). The team will train them on study goals, responsibilities, data management, and follow-up, based on the HOPE-4 training manual. Training will be given once at the beginning of their role and then once annually. The NPHW will support the participant, if needed, in contacting the family doctor and assisting to arrange a follow-up study. If required, the family doctor can contact the NPHW. If further discussion is required or there are questions regarding the study that require further discussion, the NPHW will contact the study physician to address these issues.

Who Is Running the Clinical Trial?

Sonia Anand

Lead Sponsor

Trials

1

Recruited

140+

McMaster University

Collaborator

Trials

936

Recruited

2,630,000+

Findings from Research

The My Health Matters! program successfully engaged 43% of employees in health risk assessments and identified metabolic syndrome risk factors in over half of those who attended clinical visits, leading to a significant 15% reduction in risk factors over six months.

The program was well-received, with 82% of participants recommending it to other employers, demonstrating its feasibility and value as a workplace intervention for managing metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Partnership in employee health. A workplace health program for British Columbia Public Service Agency (Canada). Tarride, JE., Harrington, K., Balfour, R., et al.[2017]

References

1. India pubmed.ncbi.nlm.nih.gov

Non-physician health workers for improving adherence to medications and healthy lifestyle following acute coronary syndrome: 24-month follow-up study. [2018]

2. Philippines pubmed.ncbi.nlm.nih.gov

Prevalence of Metabolic Syndrome and Cardiovascular Risk Factors among Community Health Workers in Selected Villages in the Philippines. [2022]

3. India pubmed.ncbi.nlm.nih.gov

Prevalence of cardiovascular risk factors among healthcare staff in a large healthcare institution in Singapore. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Can non-physician health-care workers assess and manage cardiovascular risk in primary care? [2022]

5. Spain pubmed.ncbi.nlm.nih.gov

[Effectiveness of an intervention to improve quality care in reducing cardiovascular risk in hypertense patients]. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Partnership in employee health. A workplace health program for British Columbia Public Service Agency (Canada). [2017]

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

Metabolic syndrome. [2017]

8. Iran pubmed.ncbi.nlm.nih.gov

Metabolic syndrome: a common problem among office workers. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Nutrition and Lifestyle Behavior Peer Support Program for Adults with Metabolic Syndrome: Outcomes and Lessons Learned from a Feasibility Trial. [2021]

10. Netherlands pubmed.ncbi.nlm.nih.gov

The awareness to metabolic syndrome among hospital health providers. [2018]