OBJECTIVE: To evaluate an informed shared decision-making programme (ISDM-P) for @entity1 with type 2 @entity6 under high fidelity conditions. DESIGN: Randomised, single-blinded trial with sham control intervention and follow-up of 6   months. SETTING: Single-centre @entity6 clinic providing care according to the national disease management programme in Germany. @entity1 : 154 @entity1 with type 2 @entity6 without diagnosis of @entity299 or @entity64 . INTERVENTIONS: The ISDM-P is executed by @entity6 educators. Core component is a @entity1 decision aid on the prevention of @entity583 supplemented by a 90   min group teaching session. The structurally equivalent control intervention addresses stress issues. MAIN OUTCOME MEASURES: Primary outcome was risk comprehension, including realistic expectations about benefits and harms of interventions. It was assessed by a 12-item questionnaire after the teaching session when @entity1 set and prioritise their treatment goals. Key secondary outcome was adherence to treatment goals, operationalised as achievement of individual goals and medication uptake. ISDM-P teaching sessions were video-taped to monitor intervention fidelity. RESULTS: 72 of 77 ISDM-P and 71 of 77 control @entity1 completed the questionnaire (score 0-12). ISDM-P @entity1 achieved higher levels of risk comprehension, mean score 8.25 vs 2.62, difference 5.63 (95% CI 4.82 to 6.44), and realistic expectations (score 0-6), 4.51 vs 0.85, 3.67 (3.23 to 4.11). More ISDM-P @entity1 wished to take statins, 59.2% vs 30.4%, 28.7% (12.9% to 44.5%); more prioritised blood pressure control, 51.4% vs 25.7%, and fewer intensive @entity413 control, 33.3% vs 60%, p=0.002. More ISDM-P @entity1 achieved their glycated haemoglobin goals, 95.8% vs 85.7%, 10.1% (0.6% to 19.5%). Achievement of prioritised goals and medication uptake were comparable between groups. CONCLUSIONS: The ISDM-P on preventive measures in type 2 @entity6 was effective under high fidelity conditions. Involvement of @entity6 educators may facilitate implementation of the informed shared decision-making. TRIAL REGISTRATION NUMBER: ISRCTN84636255.

Informed shared decision-making programme on the prevention of XXXX in type 2 @entity6 : a randomised controlled trial.

@entity1 :: ('9606', 'Species') :: ['patients', 'patient', 'PARTICIPANTS', 'people'] @entity64 :: ('MESH:D020521', 'Disease') :: ['stroke'] @entity6 :: ('MESH:D003920', 'Disease') :: ['diabetes'] @entity299 :: ('MESH:D006331', 'Disease') :: ['ischaemic heart disease'] @entity583 :: ('MESH:D009203', 'Disease') :: ['myocardial infarction'] @entity413 :: ('MESH:D005947', 'Chemical') :: ['glucose']
@entity583 :: (MESH:D009203,Disease) :: ['myocardial infarction']
