NCT03863210

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

Completed NA Results posted Last updated 9 October 2020

What this trial tests

NA trial testing 60-minute lecture titled "Change of lifestyle and nutrition habits to reduce cardiovascular risk" in Cardiovascular Risk Factor in 104 participants. Completed in 1 March 2015.

Timeline

1 March 2014

Primary endpoint
1 September 2014

1 March 2015

Quick facts

Lead sponsor	University of Split, School of Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	104
Start date	1 March 2014
Primary completion	1 September 2014
Estimated completion	1 March 2015

Drugs / interventions tested

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

Conditions studied

• Cardiovascular Risk Factor — all drugs for Cardiovascular Risk Factor →

Sponsor

University of Split, School of Medicine

Who can join

Adults 45 to 60, female only, with Cardiovascular Risk Factor. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Ten Year Risk of Cardiovascular Disease (CVD) Primary · 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.

Group	Value	95% CI
Participants Who Received Informations About Lifestyle Change	2.9	2.2 – 3.6

Decisional Conflict (DC) Primary · 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.

Group	Value	95% CI
Participants Who Received Informations About Lifestyle Change	27	25 – 30

State Hope Primary · 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 validate

Group	Value	95% CI
Participants Who Received Informations About Lifestyle Change	105	102 – 108

Waist Circumference Secondary · Change from baseline waist circumference at 3 months

Group	Value	95% CI
Participants Who Received Informations About Lifestyle Change	89	87 – 92

Hips Circumference Secondary · Change from baseline hips circumference at 3 months

Group	Value	95% CI
Participants Who Received Informations About Lifestyle Change	107	105 – 110

Weight Secondary · Change from baseline weight at 3 months

Group	Value	95% CI
Participants Who Received Informations About Lifestyle Change	61	54 – 68

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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
   Petricevic SJ, Pavlicevic I, Mrduljas-Dujic N, Curcic L, et al · · 2020 · DOI 10.21203/rs.3.rs-28912/v1