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Table 1 Enrollment and assessment schedule for the study (SPIRIT schedule)

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

 

Study period

Enrollment

Allocation

Post-allocation

Time point

 

0

T1 = 6 months

Enrolment:

   

 Eligibility screen

X

  

 Informed consent

X

  

 Pooled coherent risk equation

X

  

 Allocation

 

X

 

Intervention:

   

 Nurse-led lifestyle choice and coaching interventions

   

Assessments:

   

 Baseline variables

- Predicted 10 years ASCVD risk

- BMI

- Glycated hemoglobin

- Systolic blood pressure

- Total cholesterol

Proportion of patients at target for:

- Glycated hemoglobin

- Systolic blood pressure

- Diastolic blood pressure

- Total cholesterol

- LDL cholesterol

  

 Outcome variables

  

1) Mean change in systolic blood pressure

2) Absolute and relative change in predicted 10-year ASCVD risk

3) Absolute increase in proportion of patients at target for:

-Systolic blood pressure

-Diastolic blood pressure

-Total cholesterol

-Glycated hemoglobin

-LDL cholesterol