Acute coronary syndrome and essential hypertension Circulatory System
Conditions
Interventions
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 t
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
Sponsors
University of Milano Bicocca
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
Exclusion criteria: 1. Unable to complete the study measures and interventions in Italian. 2. Affected by other serious diseases (such as cancer) or psychiatric disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Italy
Outcome results
None listed