SMART-INFORM

Authors
Category Primary study
Registry of TrialsNetherlands Trial Register
Year 2017
INTERVENTION: The three‐arms of this trial are: 1. Standard‐communication practices only (Control Group) 2. Standard‐ communication practices plus personalized information on a. Prediction passport: 10‐year risk of recurrent event and change in absolute risk associated with statin therapy. b. Educational video’s c. Telephone conversation 3. Standard‐communication practices plus personalized information on a. Prediction passport: Recurrent cardiovascular event‐free life expectancy and change in recurrent cardiovascular event‐free life‐expectancy associated with statin therapy b. Educational video’s c. Telephone conversation CONDITION: Cardiovascular prevention, Shared decision making ; ; PRIMARY OUTCOME: Patient experience with decision‐making, measured using the Decisional Conflict ; Scale (DCS), 1 month post‐intervention. SECONDARY OUTCOME: 1. Prolonged Improved Patient Decision‐Making; Measured with Decisional ; Conflict Scale (DCS) questionnaire at 6 months ; ; 2. Self‐reported medication adherence; ; questionnaire at 1, and 6 months ; ; 3. Patients’ illness perceptions; Measured with Brief Illness Perception ; Questionnaire (IPQ) questionnaire; at 1 and 6 months ; ; 4. Understanding of therapy‐effects; Measured with Understanding of Therapy ; questionnaire, designed for this study at 1 and 6 months ; ; 5. General practitioners’ assessment of the intervention; Measured with ; questionnaire designed for this study at 1 month ; ; 6. Patient Activation ; questionnaire at and 6 months ; ; 7. Patient Reported Shared Decision‐Making, measured with the 9 ‐item ; Shared Decision Making Questionnaire (SDMQ9), 1 month post intervention. ; ; 8. Patient Perception of Statin Efficacy, measured using a visual analog ; scale at 1 and 6 months. ; ; 9. Quality of Life ; questionnaire at 6 months. ; ; 10. Serum LDL‐c (mmol/L) levels, 6 months after intervention, as documented ; the primary Care Dossier (last observation carried forward) INCLUSION CRITERIA: 1. Inclusion in the SMART study (NL45885.041.13) 2. Clinically manifest cardiovascular disease, such as a confirmed diagnosis or strong clinical suspicion of one of the following: coronary artery disease, cerebrovascular disease, peripheral artery disease. 3. Use of statin medication at baseline 4. Between 18 and 80 years of age 5. Rankin Scale <3
Epistemonikos ID: b61cad9ec1c91f8cc0230d05d4a5b4da05392fbc
First added on: Aug 23, 2024