A cluster randomized controlled trial to evaluate a disease and care-management intervention for cardiovascular prevention in primary care: The Raffaello Project.

Not Applicable

Completed

• Conditions: cardiovascular disease primary and secondary prevention; Cardiovascular - Coronary heart disease; Stroke - Ischaemic; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12611000813987
• Lead Sponsor: Marche Regional Healthcare Agency

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

Patients with at least one of the following cardiovascular risk factors were considered eligible for the project:
Arterial blood pressure: >=140/90 mmHg
Dyslipidemia: LDL >=160 mg/dL for primary prevention and LDL >=100 mg/dL for secondary prevention
Diabetes mellitus: Hb1AC >=7%
Obesity: BMI >=30
Smoking status (at least one cigarette/day)

Exclusion Criteria

Patients did not provide informed consent or presented with one of the following condition were excluded from the trial:
Mental illness
Institutionalization in a nursing home
Pregnant status

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of patients reaching target level recommended by the international guidelines at least for one of the cardiovascular risk factors present at enrolment without worsening and/or developing any other risk factor.<br>Recommended Targets<br>Hypertension: BP < 140/90 or <130/80 if previous CHD event, diabetes mellitus o renal disease.<br>Diabetes Mellitus: HbA1c < 7%.<br>Hypercholesterolemia: LDL-C<100 mg/dL if previous CHD event and/or diabetes or LDL-C<130 mg/dL if no previous CHD event and no diabetes and >1 CHD risk factors or LDL-C<160 mg/dL if no previous CHD event and no diabetes and 1 CHD risk factor.<br>Obesity: BMI < 30[at 12 month of follow-up]

Secondary Outcome Measures

Name	Time	Method
the proportion of patients achieving recommended target for single risk factors: hypertension, diabetes mellitus, hypercholesterolemia, smoking and obesity.<br>Recommended Targets<br>Hypertension: BP < 140/90 or <130/80 if previous CHD event, diabetes mellitus o renal disease.<br>Diabetes Mellitus: HbA1c < 7%.<br>Hypercholesterolemia: LDL-C<100 mg/dL if previous CHD event and/or diabetes or LDL-C<130 mg/dL if no previous CHD event and no diabetes and >1 CHD risk factors or LDL-C<160 mg/dL if no previous CHD event and no diabetes and 1 CHD risk factor.<br>Obesity: BMI < 30[at 12 month of follow-up];the proportion of patient changing the class of risk of fatal cardiovascular event using SCORE (Systematic COronary Risk Evaluation) risk estimation system of the European Society of Cardiology (ESC)[at 12 month of follow-up]