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Table 2 Phase II baseline and follow-up assessments

From: Supported self-management for adults with type 2 diabetes and a learning disability (OK-Diabetes): study protocol for a randomised controlled feasibility trial

 

Med notes review/check

Pre- baseline phone call

Baseline interview

Nurse baseline

6 month medical/ nurse follow-up

6 month follow-up interview

Med notes follow-up

Eligibility and consent

       

 Presence and role of a supporter and/or research advocate

  

X

  

X

 

 Mental capacity to consent to Phase II (P, R)

  

X

    

 Eligibility for Phase II (assessed by Study Researcher)

X

X

X

    

 Consent for Phase II (P, S, Ra)

  

X

    

Follow-up data (P, S, R, N)

       

 Negative outcomes

     

X

 

 Related and Unexpected Serious Adverse Events

     

X

 

 Hospital attendances

     

X

 

 Current physical health state (for example, HbA1c, BP, BMI, weight, BP, HbA1C, cholesterol, HDL/ LDL triglycerides, Urea and Electrolytes, waist to hip ratio (N)

X

  

X

X

  

 Thyroid function, height (N)

   

X

   

 Q Risk, Retinal screening, Medication, Serum creatinine, micro-albuminuria

      

X

 Details of Treatment Received

     

X

 

 Adherence to the intervention (N)

     

X

 

 Prescribed diabetes regime (diet, exercise)

     

X

 

Questionnaires (completed at Researcher visit)

       

 Health Economics questionnaire (P and S interviewer administered) to cover health and social care costs, participant and supporter expenses and productivity costs

  

X

  

X

 

 Participant (P) mood (questions taken from Phase I)

  

X

  

X

 

Health-related quality of life (EQ5D) (P)

  

X

  

X

 
  1. BP=Blood pressure, BMI = body mass index, HbA1c = glycated haemoglobin
  2. aP, Participant; S, Supporter; R, Researcher; N, Research Nurse