SCORE! Non-Physician Health Worker (NPHW) Implementation Protocol (SIP).
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Sonia Anand
- 入组人数
- 137
- 试验地点
- 2
- 主要终点
- Framinghman risk score (FRS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants will be identified from the SCORE! Cohort study who have previously received a letter indicating their cardiovascular risk score.
- •They are eligible if:
- •Uncontrolled CV risk factors will be defined as follows:
- •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%
排除标准
- •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
结局指标
主要结局
Framinghman risk score (FRS)
时间窗: 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
次要结局
- HbA1c(12 months)
- InterHEART Risk Score (IHRS)(12 months)
- Tobacco(12 months)
- Tabocco(12 months)
- Implementation of the recommended tratment.(12 months)
- Adherence to the NPHW's recommendations(12 months)
- Blood pressure(12 months)
- Lipid panel(12 months)
- Lipid Panel(12 months)
研究者
Sonia Anand
Associate Vice-President, Global Health Department, Professor of Epidemiology, Vascular Medicine Specialist, Principal Investigator
McMaster University