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Table 1 Standard Protocol Items (SPIRIT): details on the scheduled activities related to patient enrollment, interventions, and study variables at different time points

From: Individualized mobile health interventions for cardiovascular event prevention in patients with coronary heart disease: study protocol for the iCARE randomized controlled trial

  Study period
Enrollment Allocation Post allocation Closeout
Time point −T1 T0 T1 T2 T3 T4 T5 T6
Enrollment
Eligibility screen X        
Informed consent X        
Allocation   X       
Interventions   X X X X X X X
Assessments         
Major cardiovascular events    X X X X X X
Health behaviors
Smoking status   X X X X X X X
Dietary intake   X X X X X X X
Physical activity   X X X X X X X
Medication adherence   X X X X X X X
Anthropometry parameters
Weight   X X X X X X X
Body mass index   X X X X X X X
Waist circumference   X X X X X X X
Biochemical parameters
Total cholesterol   X   X X X X X
Low-density lipoprotein cholesterol   X   X X X X X
High-density lipoprotein cholesterol   X   X X X X X
Fasting blood glucose   X   X X X X X
Hemoglobin A1c   X   X X X X X
Systolic blood pressure   X   X X X X X
Diastolic blood pressure   X   X X X X X
10-year Framingham risk scores of cardiovascular risks   X   X X X X X
All-cause mortality    X X X X X X
All-cause readmission    X X X X X X
Frequency of medical treatment due to CHD    X X X X X X
Patients’ engagement in the intervention    X X X X X X
Mediators and moderators of behavior changea
Risk perception   X    X X X X
Outcome expectation   X    X X X X
Action planning   X    X X X X
Coping planning   X    X X X X
Behavioral enjoyment   X    X X X X
Social support   X    X X X X
Self-efficacy   X    X X X X
Effectiveness perception   X    X X X X
Intention   X    X X X X
Motivation   X    X X X X
Volition   X    X X X X
Stages of behavior changea   X    X X X X
Knowledge of CHD   X    X X X X
Perceived importance of health behaviors   X    X X X X
  1. CHD, coronary heart disease. −T1: Start point for patient recruitment; T0: Baseline; T1: 1 month; T2: 3 months; T3: 6 months; T4: 12 months; T5: 24 months; T6: 36 months
  2. aThe stages of behavior change, mediators and moderators of behavior change will be assessed dynamically