Interventional Study to Decrease Cardiovascular Risk in Women in Primary Health Care in South Croatia

NCT03863210 | Completed Results

• 1 other identifier: No. IP-2014-09-7672
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cardiovascular Risk Factor

Keywords

cardiovascular risk; patient education; hope; decisional conflict; women

Outcome Measures

Primary Outcomes (3)

• 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.

  Change from baseline 10-year risk of CVD at 3 months

• Decisional Conflict (DC)

  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.

  Change from baseline DC at 3 months

• State Hope

  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.

  Change from baseline state hope at 3 months

Secondary Outcomes (3)

• Waist Circumference

  Change from baseline waist circumference at 3 months

• Hips Circumference

  Change from baseline hips circumference at 3 months

• Weight

  Change from baseline weight at 3 months

Study Arms (1)

Participants who received informations about lifestyle change

EXPERIMENTAL

Other: 60-minute lecture titled "Change of lifestyle and nutrition habits to reduce cardiovascular risk"

Interventions

60-minute lecture titled "Change of lifestyle and nutrition habits to reduce cardiovascular risk" OTHER

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.

Participants who received informations about lifestyle change

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• current cardiovascular disease (CVD) (ischemic heart disease, peripheral artery disease, and stroke)
• malignant diseases
• serious systemic or mental diseases

Sponsors & Collaborators

• University of Split, School of Medicine: lead

Limitations and Caveats

These results should be considered in view of the limitation that we could not use a control group in the setting where the intervention was delivered.

Results Point of Contact

• Title: Dr. Slavica Jurić Petričević
• Organization: University of Split School of Medicine

slavica.juric01@gmail.com

Study Officials

• Slavica Jurić Petričević

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2019
• First Posted: March 5, 2019
• Study Start: March 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: March 1, 2015
• Last Updated: October 9, 2020
• Results First Posted: October 9, 2020

Record last verified: 2019-02