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. 2018 Jul 19;2018(7):CD006732. doi: 10.1002/14651858.CD006732.pub4

NCT02285881.

Trial name or title Shared decision making between patients and GPs in the treatment of Type 2 diabetes in primary care
Methods Cluster‐randomized trial
Participants Patients with type 2 diabetes mellitus aged 60 years to 80 years
Interventions Experimental: shared decision making
Quote: "In the intervention practices the SDM process is used. In the SDM process the patient and GP use a decision aid to discuss the pros and cons of two evidence based treatment possibilities, according to the Dutch College of General Practitioners (NHG) versus the ADDITION guideline, and the patients' preferences for either of these treatments. Together they choose one of these treatments, and set the five treatment targets (blood pressure, cholesterol, HbA1c, smoking status and weight) in order of priority. Subsequent treatment will take place according to the priorities of these OPTIMAL treatment targets. The priorities will be evaluated every 12 months."
No Intervention: control group
Quote: "Patients in the control practices will receive treatment‐as‐before, which means that the patients will not be offered the structured SDM process. So the GP will treat the former ADDITION patients as they were used during the period that followed after the ADDITION study (2009), either according to the national guidelines or to the ADDITION intensive treatment algorithm."
Outcomes Primary outcome
The between groups difference in the proportion of patients which achieve the treatment goals for HbA1c, blood pressure, and total cholesterol.
Secondary outcomes
  • The difference between groups in the proportion of patients which achieved the five treatment goals for HbA1c, blood pressure, total cholesterol, body weight, and smoking.

  • Characteristics of success for the SDM process in the patients in the intervention group.

  • The difference in health related Quality of Life between both groups at 24 months as measured with the Audit of Diabetes Dependent Quality of Life and the European Quality of Life questionnaire.

  • The difference in health status between both groups at 24 months as measured with the Short Form‐36.

  • The difference in well‐being between baseline and 24 months within and between both groups as measured with the Well‐Being Questionnaire.

  • The difference in well‐being between baseline and 24 months within and between both groups as measured with the Well‐Being Questionnaire.

  • The difference in coping style between baseline and 24 months within and between both groups as measured with the Diabetes Coping Measurement Questionnaire.


Other Outcome Measures
  • Process evaluation of the SDM ability of the general practitioners by using the Shared Decision Making Questionnaire.

Starting date March 2012
Contact information Contact information is only displayed when the study is recruiting participants
Notes The study is completed but not published yet