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HypertensionSIPNCT06694987

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

A study testing Non-Physician Health Worker in people with Hypertension and Diabetes Mellitus, run by Sonia Anand at 1 site in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertension, Diabetes Mellitus, Dyslipidemia
What is being tested?
Non-Physician Health Worker
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
137 participants
Where
1 siteCanada
Study dates
20 Nov 2024to 1 Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sonia Anand, PhD, MD contact

905-525-9140 ext. 21523

anands@mcmaster.ca

Dipika Desai, MSc contact

289-3392629

desaid@mcmaster.ca

Canada1 site

  • McMaster University

    Hamilton, Ontario, L8S 4L8

    Dipika Desai, MSc, 2893392629, desaid@mcmaster.ca

    Patricia Montague, MSc, 905-525-9140 ext. 21523, pmontag@mcmaster.ca

Other trials in Canada

About this study

Official title: SCORE! Non-Physician Health Worker (NPHW) Implementation Protocol (SIP).

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.

Read the 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.

Being tested
Non-Physician Health Worker
Keywords
Cardiovascular, Healthy active living, Newcomer, Non-Physician Health Worker
Medical subject headings
Hypertension, Diabetes Mellitus, Dyslipidemias, Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non-Physician Health WorkerOther

    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.

Study groups in NCT06694987
Study groupRoleWhat they receive
Implementation group.ExperimentalThe 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.
Receives: Other: Non-Physician Health Worker

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months

Secondary outcomes (14)

  1. HbA1c

    Change in HbA1c for diabetic individuals.

    Measured: 12 months

  2. HbA1c

    Proportion of patients with an HbA1c less than 7.0 percent.

    Measured: 12 months

  3. Blood pressure

    Change in blood pressure (BP) in mm/Hg.

    Measured: 12 months

  4. Blood pressure

    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.

    Measured: 12 months

  5. Lipid panel

    Change in low density lipoproteins (LDL) (mmol/L).

    Measured: 12 months

  6. Lipid Panel

    Change in HDL (mmol/L)

    Measured: 12 months

  7. Lipid panel

    Change in total cholesterol (mmol/L).

    Measured: 12 months.

  8. Lipid panel

    Change in triglycerides (mmol/L).

    Measured: 12 months

  9. Lipid Panel

    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.

    Measured: 12 months

  10. InterHEART Risk Score (IHRS)

    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

    Measured: 12 months

  11. Tobacco

    Proportion of individuals who reduced smoking.

    Measured: 12 months

  12. Tabocco

    Proportion of participants who quit smoking.

    Measured: 12 months

  13. Implementation of the recommended tratment.

    Proportion of physicians who implemented the recommended medical therapy, by the study.

    Measured: 12 months

  14. Adherence to the NPHW's recommendations

    Proportion of participants who implemented changes to healthy active living (HAL), recommended by the NPHW.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2024
  2. Study start20 Nov 2024 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion1 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
This is a quasi-experimental, one group, pre-post design study.
Masking
None (open label)
Enrolment
137 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06694987
Sponsor's protocol ID
SCORE! - SIP
Acronym
SIP
Status last verified
Nov 2024
First submitted
11 Oct 2024
Last updated
19 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We currently dont have plans for sharing IPD. If this changes in the future, the consent form explains as follow: The participant's personal, identifiable data will not be shared with anyone except with the participant's consent or as required by the laws of the province of Ontario. All information that could identify the participant, such as name and phone number, will only be accessible to the study members who need this information to contact the participant for study purposes (e.g., invite the participant to activities). Before the investigators analyze the data collected, all identifying information will be removed. The de-identified data will be retained until it no longer hold scientific value. If the participant previously consented to sharing of data with other researchers or to data repositories in the main cohort study, data from this study will also be shared. If the participant no longer wish for this to occur the investigators will be notified. HiREB # 17633

Publications

  • 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.

    PubMed 31488369

Questions about this trial

What is this clinical trial studying?

A study testing Non-Physician Health Worker in people with Hypertension and Diabetes Mellitus, run by Sonia Anand at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sonia Anand, PhD, MD (905-525-9140 ext. 21523, anands@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Framinghman risk score (FRS) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06694987, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.

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SIP Clinical Trial NCT06694987 | AzTrials