Skip to main content

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