Association of the State Hope and Decisional Conflict With the Outcomes of an Educational Intervention to Decrease Cardiovascular Risk in Women: Mixed Methods Study in Primary Health Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 主要终点
- Ten Year Risk of Cardiovascular Disease (CVD)
研究概览
简要总结
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.
详细描述
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".
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female sex
- •age 45 to 60 years
- •one or more CV risk factors [overweight or obesity, i. e. body mass index (BMI) ≥25 kg/m2, and/or central obesity - waist circumference ≥88 cm, high blood pressure (systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg), high blood cholesterol (≥5.2 mmol/L) and active smoking]
- •participants on antihypertensive therapy were also included in the study
排除标准
- •current cardiovascular disease (CVD) (ischemic heart disease, peripheral artery disease, and stroke)
- •malignant diseases
- •serious systemic or mental diseases
结局指标
主要结局
Ten Year Risk of Cardiovascular Disease (CVD)
时间窗: Change from baseline 10-year risk of CVD at 3 months
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.
Decisional Conflict (DC)
时间窗: Change from baseline DC at 3 months
DC was estimated using Decisional Conflict Scale (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.
State Hope
时间窗: Change from baseline state hope at 3 months
State hope was estimated using Integrative Hope Scale (IHS), 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.
次要结局
- Hips Circumference(Change from baseline hips circumference at 3 months)
- Waist Circumference(Change from baseline waist circumference at 3 months)
- Weight(Change from baseline weight at 3 months)