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

Recruiting in Palo Alto (17 mi)

Overseen bySonia Anand, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Sonia Anand

No Placebo Group

Trial Summary

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.

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

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Treatment Details

Interventions

Non-Physician Health Worker (Behavioural Intervention)

Trial OverviewThe 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

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.