← Back to Search

Behavioural Intervention

Non-Physician Health Worker Support for Metabolic Syndrome (SIP Trial)

N/A

Waitlist Available

Led By Sonia Anand, MD, PhD

Research Sponsored by Sonia Anand

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Severe co-morbid conditions with life expectancy < 1 year

Known history of coronary artery disease or stroke

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to improve the health of people with abnormal blood sugar, fat levels, high blood pressure, and heart disease risks. Non-Physician Health Workers will work under a medical doctor to help

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this intervention involves lifestyle management and monitoring by Non-Physician Health Workers rather than medication or invasive procedures, there are no direct side effects as typically associated with drug trials.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have severe health conditions that would limit my life to less than a year.

Select...

I have a history of heart disease or stroke.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Framinghman risk score (FRS)

Secondary study objectives

Adherence to the NPHW's recommendations

Blood pressure

HbA1c

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Implementation group.Experimental Treatment1 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.

0 / 2Eligibility criteria met