Clinical trial NCT06694987: SCORE! Non-Physician Health Worker (NPHW) Implementation Protocol (SIP)
Official title: SCORE! Non-Physician Health Worker (NPHW) Implementation Protocol (SIP).
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertension
Diabetes Mellitus
Dyslipidemia
Metabolic Syndrome
Keywords: Cardiovascular
Healthy active living
Newcomer
Non-Physician Health Worker
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: McMaster University
First posted: 2024-11-19
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a quasi-experimental, one group, pre-post design study.
Primary purpose: OTHER

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.

Eligibility criteria: 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 \&amp;amp;gt; 2.66 mmol/L;
* Random plasma glucose of ≥ 11.1 mmol/L or HbA1c% ≥ 6.5%

Exclusion criteria include:

* 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

Primary outcomes:
measure: Framinghman risk score (FRS)
timeFrame: 12 months
Secondary outcomes:
measure: HbA1c
timeFrame: 12 months
measure: HbA1c
timeFrame: 12 months
measure: Blood pressure
timeFrame: 12 months
measure: Blood pressure
timeFrame: 12 months
measure: Lipid panel
timeFrame: 12 months
measure: Lipid Panel
timeFrame: 12 months
measure: Lipid panel
timeFrame: 12 months.
measure: Lipid panel
timeFrame: 12 months
measure: Lipid Panel
timeFrame: 12 months
measure: InterHEART Risk Score (IHRS)
timeFrame: 12 months
measure: Tobacco
timeFrame: 12 months
measure: Tabocco
timeFrame: 12 months
measure: Implementation of the recommended tratment.
timeFrame: 12 months
measure: Adherence to the NPHW's recommendations
timeFrame: 12 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Sonia Anand, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Lita Cameron, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.