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Table 2 SPIRIT diagram (t0= baseline; t1=1 month after baseline; t2=3 months after baseline; t3=6 months after baseline) [33]. *Satisfaction phone call will only be performed in participants that receive the intervention condition

From: A personalised intervention programme aimed at improving adherence to oral antidiabetic and/or antihypertensive medication in people with type 2 diabetes mellitus, the INTENSE study: study protocol for a randomised controlled trial

 

Study period

Enrolment

Pre-randomisation

Randomisation

Post-randomisation

TIME POINT

   

t0

t1

t2

t3

ENROLMENT

       

In-practice electronic search

X

      

Written invitation

X

      

Information phone call, including eligibility screening

X

      

Informed consent

X

      

Randomisation

  

X

    

INTERVENTIONS

       

Intervention

   

Control

   

ASSESSMENTS

       

Telephone pill count

   

X

  

X

Blood pressure

   

X

  

X

HbA1c

   

X

  

X

Satisfaction phone call*

    

X

  

Adapted QBS

 

X

     

Demographics

 

X

     

MARS-5

 

X

   

X

X

BMQ Specific

 

X

   

X

X

DTSQs

 

X

   

X

X

DTSQc

      

X

EQ-5D-5L

 

X

   

X

X

iMTA costs

     

X

X