Background
Research Objectives
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To improve lipid levels in patients;
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To reduce cardiovascular risk;
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To improve patients' diet (adherence to the Mediterranean diet and reduction of saturated fat intake);
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To increase physical activity;
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To reduce body weight in patients with overweight or obesity;
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To improve adherence to prescribed hypolipidemic drugs.
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To check the effect of the MI training program on the participating GPs allocated to the experimental group.
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To validate a measuring instrument specifically designed for assessing the use of MI (EVEM scale) among GPs.
Methods/Design
Study Design
Sample Size
Participants
General Practices
Patients
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Defined hypercholesterolemia: total cholesterol >250 mg/dl (6.45 mmol/l) and triglycerides <200 mg/dl (2.26 mmol/l);
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Hypertriglyceridemia: total cholesterol <200 mg/dl (5.17 mmol/l) and triglycerides >200 mg/dl (2.26 mmol/l).
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Mixed hyperlipidemia: total cholesterol >200 mg/dl (5.17 mmol/l) and triglycerides >200 mg/dl (2.26 mmol/l).
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Patients with pathologies that can produce secondary dyslipidemIa and need pharmacological therapy;
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Subjects with previous cardiovascular events or other chronic conditions as diabetes or severe Chronic obstructive pulmonary disease, cancer, serious liver alterations, chronic renal failure, at-risk or alcoholic drinkers, drug users;
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Patients on long-term sick leave;
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Pregnant or nursing women;
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Subjects unable to comply with the study procedures for their personal characteristics (cognitive level, altered psychological status, etc)
Randomisation
Study Intervention
Intervention Group
ID code: Behavior studied: Time devoted to the interview (min): | ||||
To what extend does the professional... | 0 | 1 | 2 | NA |
1. tune with the patient through non-verbal communication? | ||||
2. show empathy at appropriate times? | ||||
3. make proper patient positioning concerning the behavior in question? | ||||
4. works consistently with the positioning of the patient throughout the interview? | ||||
5. use open-end questions? | ||||
6. validates genuinely the patient (abilities, skills, effort, interest...) ? | ||||
7. perform reflective listening? | ||||
8. make summaries of the information provided by the patient? | ||||
9. strengthens change talk? | ||||
10. give attention to the patient's commitment to change? | ||||
11. identifies resistance to change and use specific strategies to avoid and handle them? | ||||
12. provides information adapted to the patient's difficulties and needs? | ||||
13. promotes the definition and/or prioritization of the objectives of change with the patient? | ||||
14. negotiates and test a feasible action plan considering the patient's options? | ||||
15. once change has started, develop maintenance strategies with the patient? | ||||
16. in case of relapse, create a climate of acceptance, trying to promote patient's self-efficiency? |
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Videotape Analysis. It is performed using the EVEM scale (Table 1), which is currently being concurrently validated in the project itself. This scale will be used by GPs for self-assessment (self-perception) and by the researchers (peer review). The inter-observer concordance level will be analyzed.
Control Group
Outcome Measurement and Tools
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Blood analysis: total cholesterol levels, LDL and HDL cholesterol, and triglycerides.
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Cardiovascular risk: to assess cardiovascular risk, we will use the SCORE table for low-risk European population [28, 29], the table of the REGICOR study [30], and Framingham's equations [31] by using the application Circe.exe http://www.1aria.com/sections/cardiovascular/hipertension/HipertensionCalculadorasRiesgo.aspx that, when data are entered, automatically calculates the figures corresponding to each cardiovascular risk function.
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Anthropometric data: weight, height and body mass index (BMI: kg/m2).
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Diet: questionnaire on adherence to the Mediterranean diet, validated for Spain [34].
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Physical activity and sedentary behavior: the International Physical Activity Questionnaire -IPAQ- [35] will be used to quantify the level of physical activity.
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Total cholesterol < 200 mg/dl (5.2 mmol/l) and LDL cholesterol <130 mg/dl (3.4 mmol/l).
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Severe hyperlipidemia total cholesterol ≥ 320 mg/dl(8 mmol/l) or LDL cholesterol ≥ 240 mg/dl (6 mmol/), considered high-risk patients: to reduce total cholesterol <175 mg/dl - <4.5 mmol/l- (155 mg/dL if possible) and LDL cholesterol <100 mg/dl - <2.5 mmol/l- (<80 mg/dL if possible).
Trial Procedure
Recruitment
Practice recruitment
Patient recruitment
Analysis
Primary Analysis
Process Evaluation
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Video recordings with standardized and real patients.
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Monthly contacts via telephone and at least one visit to the center of each of the participating researchers.
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Validation and use of EVEM for the evaluation.
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As a self-control and reinforcing mechanism, after the interview, professionals will fill in an autocheck-list by using the EVEM questionnaire (table 1).