Interventional Study to Decrease Cardiovascular Risk in Women in Primary Health Care in South Croatia
Condition: Cardiovascular Risk Factor
Study type: Interventional

Summary: 
      Patient education in lifestyle changes has a positive effect on health in individuals with
      cardiovascular (CV) risk Despite current positive evidence about lifestyle and dietary change
      in the prevention of CVD, the recommendations are still not consistently and optimally
      applied to women, particularly in relation to their menopausal status. More information is
      needed about factors that will support effective implementation of educational interventions
      for decreasing CV risk. The aim of our study was to analyze the effect of an educational
      intervention, presented as a 60-minute lecture in primary health care setting about CV risk
      factors to women with different menopausal status, in relation to their decisional conflict
      about their treatment for CV risk and hope that their health will improve according to
      desired expectations.
    

Detailed description: 
      The study took place in family medicine (FM) offices from 1 March to 1 September 2014. Two FM
      offices were in the city of Split, the capital of the Split-Dalmatian County, one office in
      the neighboring Adriatic island of Brač and one in the southern Adriatic island of Korčula.

      All participants reported their most recent menstrual period. To assess the impact of
      reproductive status, we used the categorization proposed by the "Stages of Reproductive Aging
      Workshop" (STRAW): 1) premenopausal (PRE) women - last period reported within 61 days before
      the intervention; 2) perimenopausal (PERI) women - last period reported 61-365 days before
      the intervention; and 3) postmenopausal (POST) women - last period reported more than 365
      days before the intervention.

      All participants were exposed to the intervention. The intervention consisted of a 60-minute
      lecture titled "Change of lifestyle and nutrition habits to reduce cardiovascular risk". The
      lecture was delivered in family medicine offices by four specialists of family medicine
      individually to the groups of 6-8 participants. The lecture was verbal, harmonized among four
      family physicians, and contained instructions for changing nutrition habits, smoking habits
      and instructions for increasing physical activity. At the end of the lecture, each
      participant received a personally tailored decision aid, which included the list of her risk
      factors, assessment of the 10-year risk of fatal CVD (based on the data provided by the
      participants before the lecture), and instructions on what she should do in terms of changing
      the lifestyle habits.

      The study participants first completed the Pre-study questionnaire (Questionnaire 1), which
      included: a) demographic data, b) attitudes and knowledge questionnaire about CV risk
      factors, c) decisional conflict scale (DCS), d) integrative hope scale (IHS), and e) eating
      habits questionnaire (20).

      Attitudes and knowledge questionnaire about CV risk factors was created according to the
      model of "Ottawa Decision Support Tutorial".

      The DCS consist of 16 items rated in a 5-point Likert-type response format, and measures
      individual's uncertainty toward a course of action. There are five subscales: uncertainty,
      informed, values clarity, support and effective decision. The scores on the total scale and
      subscales are calculated as a sum of items, divided by the number of items and multiplied by
      25, allowing for a score range from zero (no decisional conflict) to 100 points (extreme
      decisional conflict). The Croatian version of the scale was previously validated.

      The IHS is 23-items scale, a self-rating instrument with items being rated on a six-point
      Likert scale from 1, strongly disagree, to 6, strongly agree. It provides an overall score
      and four dimension scores, obtained by summing up the individual item scores, with negative
      items being rated inversely. This produces possible overall hope scores ranging from 23 to
      138 with higher scores representing higher hopefulness. The scores for the sub-dimensions
      vary according to the number of items. The Croatian version of the scale was previously
      validated. Hope to be healthy at 70 and hope to reduce CV risk was assessed by a visual
      analogue scale from 0 to 100.

      EPAT is a simple, quick, self-administered tool using an easy scoring method for accurately
      assessing fat and cholesterol intake. It is a reliable and valid substitute for more
      time-consuming food records. EPAT also provides an efficient way to monitor eating patterns
      of patients over time and is arranged to provide an educational message that reinforces the
      consumption of recommended types and numbers of servings of low-fat foods. The questionnaire
      was translated into Croatian by the authors and then back translated by an independent
      language expert to confirm the translation validity.

      Ten-year risk of fatal CVD was estimated using the ACC/AHA (American College of
      Cardiology/American Heart Association) guidelines, based on the following data collected from
      the study participants: age, gender, race, total and HDL (high-density lipoprotein)
      cholesterol, systolic blood pressure, data about antihypertensive therapy, diabetes mellitus
      and smoking status.

      Immediately after the lecture, the participants filled the Post-lecture questionnaire
      (Questionnaire 2), which included: a) attitudes and knowledge about CV risk factors, b)
      decisional conflict scale (DCS) and c) integrative hope scale (IHS).

      Three months after the lecture, the participants filled in the last questionnaire
      (Questionnaire 3), which included: a) attitudes and knowledge about CV risk factors, b)
      decisional conflict scale (DCS), c) integrative hope scale (HIS) and d) eating habits
      questionnaire (EPAT). Ten-year risk of fatal CVD was also calculated at this time point.

      BMI, waist and hip circumference, systolic and diastolic blood pressure, blood cholesterol,
      triglycerides, physical activity and smoking status were measured at each of three time
      points.

      Six months after the intervention, we contacted the participants for the final assessment,
      along with their feedback on the intervention in general and their personal opinions on
      further improvements in their lifestyle. This feedback was in the form of a semi-structured
      interview conducted by the authors, the interview included 13 structured questions and 4
      open-ended questions.

      We preformed the thematic analysis of the answers, grouping them into theme categories.
      Categorization of the answers was made by the two independent assessors. After determining
      the categories, each answer was marked s 1 if matching to specific category or as 0 if not.
      Answers were used as predictors in further analysis.

      After the study, we grouped the participants into those who reduced the CV risk and those
      that did not. We used logistic regression for all parameter we measured to identify factors
      contributing to the reduction in CV risk.

      Chi square test was used to compare categorical variables (presented as absolute numbers and
      percentages). For continuous variables, presented as means with 95% confidence intervals, we
      used Mann-Whitney U test. P values ≤0.05 were considered statistically significant. Logistic
      regression was used to describe the relationships between variables. Odds ratio for each
      outcome were reported with 95% confidence interval. All statistical analyses were conducted
      using the MedCalc statistical program (version 16.2.1 MedCalc Software, Ostend, Belgium).
    

Intervention name(s): 60-minute lecture titled "Change of lifestyle and nutrition habits to reduce cardiovascular risk"
Intervention type(s): Other
Intervention description(s): All participants were exposed to the intervention. The intervention consisted of a 60-minute lecture titled "Change of lifestyle and nutrition habits to reduce cardiovascular risk". The lecture was delivered in family medicine offices by four specialists of family medicine individually to the groups of 6-8 participants. The lecture was verbal, harmonized among four family physicians, and contained instructions for changing nutrition habits, smoking habits and instructions for increasing physical activity. At the end of the lecture, each participant received a personally tailored decision aid, which included the list of her risk factors, assessment of the 10-year risk of fatal CVD (based on the data provided by the participants before the lecture), and instructions on what she should do in terms of changing the lifestyle habits.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: cardiovascular risk; patient education; hope; decisional conflict; women