An interventional study of The letters with the Cochrane abstracts in the form of blog-shots and The letters with remainder on cardiovascular risk factors in Cardiovascular Risk Factor and Lifestyle Risk Reduction, sponsored by University of Split, School of Medicine. Completed at 1 site in Croatia. Open to female participants aged 45 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-30.
Sponsored by University of Split, School of Medicine · Not applicable, Interventional, and Prevention
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.
The aim of the study was to analyze the effect of an intervention in the form of Cochrane abstract letters on women between 45 to 65 years.
The study took place in family medicine (FM) offices from 1 February 2018 to 1 June 2020. Two FM offices were in the city of Split, the capital of the Split-Dalmatian County, two offices were in Osijek, the capital of the Osijek-Baranja County, one in Kutina, and one in Rijeka.
The participants were all women between 45 to 65 years. The investigators enrolled 210 participants, and the participants were divided in three groups. The first group was control group, and participants were not exposed to the intervention. The second group was passive-intervention group, which means the participants received letters in the same time period as active-intervention group but only with a reminder at their own cardiovascular disease risk. The third group was active-intervention group, where the participants received letters every three months, with their own cardiovascular disease risk and Cochrane abstracts in the form of blog-shots.
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), and d) integrative hope scale (IHS).
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.
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. Also, BMI, waist and hip circumference, systolic and diastolic blood pressure, blood cholesterol, triglycerides, and smoking status were measured.
In the first months after recruitment, all participants received letter on home address with the count of their 10-year risk of cardiovascular disease.
After that, every two months, passive-intervention group and active-intervention group were receiving letters. The passive-intervention group of women were receiving the letters only with remainder on their own CV risk, and the active-intervention group were receiving Cochrane abstracts in the form of blog-shots.
There were three Cochrane blog-shots. The first was about calcium in prevention of high blood pressure, the second was about the effect of reducing saturated fat acids in eating habits and the third consisted informations of green and black tea for the prevention of cardiovascular diseases.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 920 are open to participants now.
This study's enrollment of 210 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →University of Split, School of Medicine is the lead sponsor of 49 studies on the registry; 16 are open to participants now.
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Exclusion Criteria:
The first group of participants was control group. The number of participant was 70, and the participants in this group after recruitment received letter with their own cardiovascular risk factors and count of their 10-year risk of cardiovascular disease.
The second group of participant was passive-intervention group. There were 70 participants. This group of women after recruitment received letter with their own cardiovascular risk factors and count of their 10-year risk of cardiovascular disease. After this letter, every two months, they were receiving remainder on their own cardiovascular risk factors and count of their 10-year risk of cardiovascular disease.
Behavioral: The letters with remainder on cardiovascular risk factors
The third group of participant was active-intervention group. There were also 70 participants. This group of women after recruitment received letter with their own cardiovascular risk factors and count of their 10-year risk of cardiovascular disease. After this letter, every two months, active-intervention group were receiving Cochrane abstracts in the form of blog-shots.
Behavioral: The letters with the Cochrane abstracts in the form of blog-shots
The active intervention were letters with the remainder on participant's own cardiovascular risk factors, a participant's own count of 10-year risk of cardiovascular disease, and Cochrane abstract in the form of blog-shots and personal advice in reducing cardiovascular disease risk. There were three Cochrane blog-shots. The first was about calcium in prevention of high blood pressure, the second was about the effect of reducing saturated fat acids in eating habits and the third consisted evidence of green and black tea for the prevention of cardiovascular diseases. The letters were sent three times, every two months after the participants received first letter about cardiovascular disease risk.
The passive intervention were letters with the remainder on participant's own cardiovascular risk factors and participant's own count of 10-year risk of cardiovascular disease. The letters were sent three times, every two months after the participants received first letter about cardiovascular disease risk.
Ten-year Risk of Cardiovascular Disease (CVD)
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.
Time frame: Change from baseline 10-year risk of CVD at 6 months
Weight
Weight in kilograms (kg).
Time frame: Change from baseline weight at 6 months
Body Mass Index (BMI)
Body mass index (BMI) is a person's weight in kilograms divided by the square of height in meters. A high BMI can be an indicator of high body fatness. BMI can be used to screen for weight categories that may lead to health problems but it is not diagnostic of the body fatness or health of an individual.
Time frame: Change from baseline BMI at 6 months
Waist Circumference
Waist circumference in centimeters (cm).
Time frame: Change from baseline waist circumference at 6 months
Hips Circumference
Hips circumference in centimeters (cm).
Time frame: Change from baseline hips circumference at 6 months
Smoking Status
Smoking status related to continued or excessive smoking.
Time frame: Change from baseline smoking status at 6 months
Plan to share: No
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University of Split, School of Medicine