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Effect of nurse-led lifestyle choice and coaching intervention on systolic blood pressure among Type 2 diabetes patients with a high atherosclerotic cardiovascular risk: study protocol for a cluster randomized trial

Effect of nurse-led lifestyle choice and coaching intervention on systolic blood pressure among Type 2 diabetes patients with a high atherosclerotic cardiovascular risk: study protocol for a cluster randomized trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202001916873358
Enrollment
384
Registered
2020-01-14
Start date
2020-07-06
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutritional, Metabolic, Endocrine Cardiology

Interventions

Nurse led life style choice and coaching intervention
Usual care

Sponsors

William Lumu
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adult men and women aged 40-79 years with a high ASCVD risk score of at least 7.5% as calculated with a Pooled Cohort Risk Equations. 2. Willing to provide informed consent. 3. Asymptomatic for ASCVD (those without a history of non-fatal myocardial infarction, stroke, heart failure, percutaneous coronary intervention, coronary artery bypass surgery or current atrial fibrillation).

Exclusion criteria

Exclusion criteria: 1. Those with symptomatic ASCVD (those with history of non-fatal myocardial infarction, stroke, heart failure, percutaneous coronary intervention, coronary artery bypass surgery or current atrial fibrillation, chronic renal failure) 2. Patients without all variables to calculate the pooled cohort risk score and baseline data. 4. Pregnant women 5. Very ill patients 6. Patients who don’t usually keep appointments that is, those who have attended clinics only once per year.

Design outcomes

Primary

MeasureTime frame
The primary outcome of the trial will be the mean difference in change in systolic blood pressure between baseline, and after 6 and 12 months between intervention and usual care groups at individual and cluster levels.

Secondary

MeasureTime frame
i) absolute difference and relative change in the predicted 10-year ASCVD risk between the intervention and usual care groups at individual and cluster levels after 6 and 12 months. ii) absolute changes in total cholesterol, low-density lipoprotein cholesterol, glycated hemoglobin, body mass index between intervention and usual care groups at individual and cluster levels after 6 and 12 months. iii) differences between groups in the change in proportion of patients reaching treatment goals for systolic blood pressure, total cholesterol, LDL cholesterol glycated hemoglobin, body mass index at individual and cluster levels after 6 and 12 months

Countries

Uganda

Contacts

Public ContactWilliam Lumu

PhD student Texila American University

dhabaguma@gmail.com+256772591911

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026