SCORE! Non-Physician Health Worker (NPHW) Implementation Protocol (SIP)
- Conditions
- HypertensionDiabetes MellitusDyslipidemiaMetabolic Syndrome
- Registration Number
- NCT06694987
- Lead Sponsor
- Sonia Anand
- 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.
- Detailed Description
Rationale: The study has been created to help SCORE! Cohort participants with cardiovascular (CV) risk to receive medical guidance and adopt healthy lifestyle recommendations through NPHW under the direction of family physicians.
Objectives: To improve/maintain CV health (measured by blood pressure, glucose levels, lipids) through implementation of simplified treatment algorithm, connection to a NPWH and referrals to primary care physicians for pharmacological management, over 12 months.
Study Design: Implementation Study.
Population: All adults 18 years or older enrolled in the SCORE! Cohort who have the following uncontrolled CV risk factors: hypertension, elevated non-High density lipoprotein (HDL) cholesterol as per the Heart Outcomes Prevention Evaluation - 4 (HOPE-4) trial criteria, and/or elevated glucose as indicated by the random glucose level or the hemoglobin A1c (HbA1C) ≥ 6.5%.
Study procedures: Participants will be identified from the SCORE! Cohort study. If the participant has CV risk factors, they will be invited to the study. After the consent procedure, the NPHW will follow an algorithm validated in the HOPE-4 trial. There will be five follow-ups over 12 months.
Primary/Secondary outcomes: A change in Framingham Risk Score (FRS) after 12 months / A change in lipid panel, blood pressure, and glucose/HbA1c, medication adherence, smoking/tobacco cessation.
Data analysis: Descriptive and multivariate analysis will be conducted on the individual level. The overall participant population will be assessed for the proportion of participants with established cardiovascular disease (CVD), and in those without CVD, the proportion of individuals with CV risk factors and the percentage of people in low, moderate, and high FRS categories.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 137
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Framinghman risk score (FRS) 12 months 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
- Secondary Outcome Measures
Name Time Method Blood pressure 12 months Change in BP as:
Proportion of participants with well-controlled BP from baseline to 12 defined as Systolic Blood Pressure (SBP) lower than 140 mmHg in non-diabetic individuals, and SBP lower than 130 mmHg in diabetic individuals.HbA1c 12 months Proportion of patients with an HbA1c less than 7.0 percent.
Lipid panel 12 months Change in triglycerides (mmol/L).
Lipid Panel 12 months Proportion of participants with LDL in target from baseline at 12 months: defined as less than 2.0 mmol/L for individuals with diabetes or who are hypertensive and over the age of 60 or individuals with moderate to high FRS. For those with LDL lower than 5.0 mmol/L - reduction of 50 percent or less than 2.50 mmol/L as per CCS guidelines.
InterHEART Risk Score (IHRS) 12 months Change in Interheart risk score (IHRS).
Low risk (\< or equal to 9) for adverse cardiac event Intermediate risk (10 to 15) for adverse cardiac event High risk (16 or higher) for adverse cardiac eventTobacco 12 months Proportion of individuals who reduced smoking.
Tabocco 12 months Proportion of participants who quit smoking.
Implementation of the recommended tratment. 12 months Proportion of physicians who implemented the recommended medical therapy, by the study.
Adherence to the NPHW's recommendations 12 months Proportion of participants who implemented changes to healthy active living (HAL), recommended by the NPHW.
Trial Locations
- Locations (1)
McMaster University
🇨🇦Hamilton, Ontario, Canada