Diabetes Mellitus, Dyslipidemia, Hypertension, Metabolic Syndrome
Conditions
Keywords
Cardiovascular, Healthy active living, Newcomer, Non-Physician Health Worker
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.
Interventions
OTHERNon-Physician Health Worker
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.
Sponsors
McMaster University
Sonia Anand
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
This is a quasi-experimental, one group, pre-post design study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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 > 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | 12 months | Change in blood pressure (BP) in mm/Hg. |
| Lipid panel | 12 months | Change in low density lipoproteins (LDL) (mmol/L). |
| Lipid Panel | 12 months | Change in HDL (mmol/L) |
| 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 event |
| HbA1c | 12 months | Change in HbA1c for diabetic individuals. |
| 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. |
| Tobacco | 12 months | Proportion of individuals who reduced smoking. |
Countries
Canada
Contacts
Primary ContactSonia Anand, PhD, MD
Backup ContactDipika Desai, MSc
Outcome results
None listed