The TTCYB study protocol: a tailored print message intervention to improve cardiovascular patients’ lifestyles

INTERVENTION: At baseline and the 6‐month follow up, patients will complete a series of self‐report questionnaires evaluating lifestyle behaviour socio‐demographic and psychological characteristics; at the 12‐month follow up, patients will have a telephone interview that will assess lifestyle habits. After the baseline measurement, patients will be randomized into one of three groups: 1. The tailored group (T), which will receive tailored health brochures 2. The “non‐tailoredâ€? group (NT), which will receive non‐tailored health brochures; 3. The usual care group (UC), which will receive no print information materials. Participants will be assigned to one of the three study groups using a stratified randomization process characterized by unpredictability of assignments. Within ten working days of completing the questionnaire, both at baseline and the 6‐month follow‐up, the T and NT groups will be mailed printed health materials while patients in the UC group will receive no materials. Patients in the T and NT group will be then contacted by phone for an interview to measure their judgment of the material. At the 12‐month follow up, all patients will have a telephone interview that will assess their lifestyle in terms of diet behaviour, physical activity, alcohol intake and smoking behaviour. CONDITION: Acute coronary syndrome and essential hypertension ; Circulatory System PRIMARY OUTCOME: ; 1. Change in lifestyle habits will be measured using self‐report questionnaires at baseline and at 6‐month follow up while at 12‐month follow up data will be collected by a telephone interview.; 1.1. Change in Diet will be measured using a modified version of the Mediterranean Diet Scale (MDS, Trichopoulou, Costacou, Bamia, & Trichopoulos, 2003).; 1.2. Physical ecercise will be measured using RAPA‐1 and RAPA‐2 of Rapid Assestment of Physical Activity (RAPA, Topolski et al., 2006).; 1.3. In order to collect data about alcohol use subjects will have to indicate the consumption of wine/beer (never; up to 2 glasses per day; up to 4 glasses per day; more than 4 glasses per day) and of super alcoholic drinks (never; occasionally just 1 glass; habitually 1 glass; habitually more than 1 glass) following a scale used by Giovannucci et al. (1991).; 1.4. Subject will have to indicate if they are smokers or not.; 2. Patients’ judgments about health material will be measured using structured phone interview questions (with a 5 Likert scale) at baseline and at 6‐month follow up (10 days after material reception). Patients will have to assess their use of the health material received in terms of usefulness, clarity, personalization, efficacy in modifying lifestyle.; INCLUSION CRITERIA: 1.18 years of age or older. 2. Diagnosis of essential arterial hypertension (SBP>=140 mmHg and/or DBP>=90 mmHg, evaluated in the standard way or by 24‐hour mean arterial pressure value [MAP] monitoring) or ACS. SECONDARY OUTCOME: ; Current secondary outcome measures as of 29/05/2019:; 1. Changes in physiological parameters will be measured using values of BMI, waist circumference, blood pressure, diabetes mellitus (presence or not) collected by a physician at baseline and at the two follow‐ups.; 2. Medical adherence will be measured using a modified version (new items added) of the Self‐reported Measure of Medication Adherence (Morisky, Green & Levine, 1986) at baseline and at the two follow‐ups.; ; Previous secondary outcome measures:; 1. Changes in physiological parameters will be measured using values of BMI, waist circumference, blood pressure, diabetes mellitus (presence or not) collected by a physician at baseline and at the two follow‐ups.; 2. Medical adherence will be measured using the 8‐items Morisky Medication Adherence Scale (MMAS, Morisky, Ang, Krousel‐Wood, & Ward, 2008) at baseline and at the two follow‐ups.;