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Table 2 Baseline and outcome parameters

From: Lifestyle counselling as secondary prevention in patients with minor stroke and transient ischemic attack: study protocol for a randomized controlled pilot study

Parameters

Methods

Baseline test

Discharge

12-weeks follow-up

1-year follow-up

Baseline data

 Demographic data

 

X

   

  Age, gender, living conditions, education, performance status [25] prior to stroke

    

 Health status

  Stroke type

ICD-10 I61, I63, I64, G45.9

X

X

  

  Stroke severity

Scandinavian Stroke Scale [26]

X

   

  Vital signs

Early warning score [27]

X

   

  Heart arrhythmia

Result of 48-72 h telemetry [28]

 

X

  

  Prior health problems

Charlson comorbidity index [29]

X

   

  Biochemistry

Glucose, HbA1c, cholesterol, LDL, VLDL, HDL, triglycerides [11]

 

X

  

  Prescribed medication

Prescribed preventive medication (Antihypertensives, antithrombotic, anticoagulatives, NOAC, statins)

 

X

  

Primary outcome

 Eligibility rate

 

X

   

 Study participation rate

 

X

   

 Adherence to the program

   

X

 

 Attrition rate

   

X

 

 Satisfaction

   

X

 

Secondary outcome

   

X

 

 Resting arterial blood pressure

Average of two or more measurements in sitting position after > 10 min resting according to 2017 US Guidelines [30]

X

 

X

 

Tertiary outcomes

 Current smoking

Self-reported tobacco smoking (daily, weekly, rarely, has quit smoking, never smoked) [31]

X

 

X

 

 Physical activity

Self-reported participation in leisure time physical activities (minutes per week of light/moderate/strenuous) [32]

X

 

X

 

 Body composition

Body mass index, hip/waist ratio

X

 

X

 

 Fatigue

Fatigue Assessment Scale [33]; 10-item questionnaire

X

 

X

 

 Self-rated health

Self-rated health current and in the last year [31]

X

 

X

 

 Adherence to preventive medication

Adherence to preventive medication (Antihypertensives, antithrombotic, anticoagulatives, NOAC, statins) the last 7 days prior to assessment

  

X

 

 Units of alcohol per week

Self-reported [31]

X

 

X

 

 Recurrent stroke/TIA

Patient medical report data

   

X

 Ischemic heart disease

Patient medical report data

   

X

 All-cause mortality

Danish Central Person Registry

   

X

  1. LDL low-density lipoprotein, VLDL very low-density lipoprotein, HDL high-density lipoprotein, NOAC novel oral anticoagulants
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Pilot and Feasibility Studies

ISSN: 2055-5784