SCORE! Non-Physician Health Worker (NPHW) Implementation Protocol (SIP)

NCT06694987 | Not Yet Recruiting

• 1 other identifier: SCORE! - SIP
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension; Diabetes Mellitus; Dyslipidemia; Metabolic Syndrome

Keywords

Cardiovascular; Healthy active living; Newcomer; Non-Physician Health Worker

Outcome Measures

Primary Outcomes (1)

• Framinghman risk score (FRS)

  A change in Framingham Risk Score from baseline to 12 months. Values are estimated as risk percentages (the likelihood) to have a major adverse cardiovascular events (MACE) within the next 10 years. \< 10 % = Low risk 10-20 % = Intermediate risk \> 20 % = High risk

  12 months

Secondary Outcomes (14)

• HbA1c

  12 months

• HbA1c

  12 months

• Blood pressure

  12 months

• Blood pressure

  12 months

• Lipid panel

  12 months

Study Arms (1)

Implementation group.

EXPERIMENTAL

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.

Other: Non-Physician Health Worker

Interventions

Non-Physician Health Worker OTHER

NPHW will aid participants in accessing a family doctor if required. The family doctor will receive a letter from the study, with suggested medication, based on the HOPE-4 algorithm. The family doctor may decide not to prescribe the recommended treatment or give another treatment (medication). In such case, the participant will still be part of the study and family physician's decision and reason why will be recorded. Follow-up will occur as per the visit schedule. All participants will attend a 20-minute follow-up visits in person at 0, 6 and 12 months, and via telephone at 3 and 9 months. Participants will be assessed to determine if: i. the patient was assessed by their family physician, ii. the family doctor initiated recommended medication treatment(s), iii. they are adhering to the medications as prescribed, iv. they implemented what the NPHW has recommended about dietary and lifestyle changes, using the specific, measurable, achivable, relevant, time-bound (SMART) for goals.

Implementation group.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Involvement in another study or program that would interfere with the study protocol,
• Known history of coronary artery disease or stroke;
• Severe co-morbid conditions with life expectancy \< 1 year,
• Pregnancy or plans to become pregnant within 12 months;
• Other serious conditions or logistic factors likely to interfere with study participation

Sponsors & Collaborators

• Sonia Anand: lead
• McMaster University: collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

Location

Related Publications (1)

• Schwalm JD, McCready T, Lopez-Jaramillo P, Yusoff K, Attaran A, Lamelas P, Camacho PA, Majid F, Bangdiwala SI, Thabane L, Islam S, McKee M, Yusuf S. A community-based comprehensive intervention to reduce cardiovascular risk in hypertension (HOPE 4): a cluster-randomised controlled trial. Lancet. 2019 Oct 5;394(10205):1231-1242. doi: 10.1016/S0140-6736(19)31949-X. Epub 2019 Sep 2.

  PMID: 31488369 BACKGROUND

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus; Dyslipidemias; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders; Insulin Resistance; Hyperinsulinism

Study Officials

• Sonia Anand, MD, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Lita Cameron, MD, MSc

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sonia Anand, PhD, MD

CONTACT

905-525-9140; anands@mcmaster.ca

Dipika Desai, MSc

CONTACT

289-3392629; desaid@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Vice-President, Global Health Department, Professor of Epidemiology, Vascular Medicine Specialist, Principal Investigator

Model Details: This is a quasi-experimental, one group, pre-post design study.

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: November 19, 2024
• Study Start: November 20, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)