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van CCT (UK)

van CCT (UK)


- candidate number26801
- NTR NumberNTR6227
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-mrt-2017
- Secondary IDsNL58608.041.16 
- Public TitleSMART-INFORM
- Scientific TitleSecondary Manifestations of Arterial Disease - Influence of Cardiovascular Prognosis and Treatment Effect Predictions on Patient and Physician Decision-Making: a Three-armed, Blinded, Randomized Controlled Trial
- hypothesis
- Healt Condition(s) or Problem(s) studiedCardiovascular prevention, Shared decision making
- 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
- Exclusion criteria 1. Pregnancy
2. Terminal malignancy or short life-expectancy
3. No follow-up possible
4. Inability to effectively communicate in Dutch
5. No informed consent (IC) signed
6. Baseline questionnaire not returned
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 8-mrt-2017
- planned closingdate1-nov-2018
- Target number of participants264
- InterventionsThe 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
- Primary outcome Patient experience with decision-making, measured using the Decisional Conflict Scale (DCS), 1 month post-intervention.
- Secondary outcome1. 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)
- TimepointsBaseline, t=0; t=6 months
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU)
- Publications
- Brief summaryRationale: In secondary cardiovascular disease (CVD) prevention, all patients are usually assumed to have both sufficient risk and potential benefit to prescribe preventative therapy. But this has repeatedly shown to be overly simplistic and may thus, result in over- and under-treatment for some patients. Individualized approaches better identify individuals who could benefit from preventative therapy.

In order to participate in sound medical decision-making, both doctors and patients must understand the reasoning behind preventative treatment. However, the translation from medical jargon to readily understandable material can be challenging. The REACH-SMART model is an individualized predication score for secondary CVD prevention and is capable of expressing prognosis both in terms of 10-year risk of a recurrent event, and in terms of cardiovascular event free life-expectancy.

Study Design: Hypothesis blinded, three-armed, randomized controlled trial nested within the ongoing SMART-study.

Study population: 1) Patients with clinical manifest vascular disease and using statins. 2) General practitioners of the randomized patients in this study.

Intervention: Personalized information concerning prognosis and effect of statin-therapy will be calculated using the REACH-SMART score. The personalized information described below will be given to patients on a written leaflet, supplemented by an educational video, and a telephone consultation. The general practitioners will receive the same written correspondence as the patients. Patients in the standard (control) group will not receive any additional information. The three randomized groups are:

1. Standard-communication practices (control group)
2. Standard- communication practices and personalized information based on
a. Individualized 10-year absolute risk of a recurrent event
b. Change in individualized absolute risk associated with statin therapy.
3. Standard-communication practices and personalized information based on
a. Individualized recurrent cardiovascular event-free life expectancy
b. Change in recurrent cardiovascular event-free life-expectancy associated with statin therapy.

Primary Endpoint: Inter-group differences in the Decisional Conflict Scale between groups at 1 month post-randomization.
- Main changes (audit trail)
- RECORD2-mrt-2017 - 29-apr-2017

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