Trial Outcomes & Findings for Interventional Study to Decrease Cardiovascular Risk in Women in Primary Health Care in South Croatia (NCT NCT03863210)

Last Updated: 2020-10-09

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

104 participants

Primary outcome timeframe

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

Results posted on

2020-10-09

Participant Flow

The study took place in family medicine offices from 1 March to 1 September 2014. Two offices were in the city of Split, one office in the island of Brač and one in the island of Korčula. There were 781 women in age 45 to 60. All patients responding to the inclusion criteria listed below are called by telephone or directly contacted in FM offices.

There were 104 women enrolled in this study, but two women came out of the study at the beginning of the study.

Participant milestones

Participant milestones
Measure	Participants Who Received Informations About Lifestyle Change 60-minute lecture titled "Change of lifestyle and nutrition habits to reduce cardiovascular risk": 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.
Overall Study STARTED	104
Overall Study COMPLETED	102
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants Who Received Informations About Lifestyle Change n=102 Participants 60-minute lecture titled "Change of lifestyle and nutrition habits to reduce cardiovascular risk": 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.
Age, Categorical <=18 years	0 Participants n=102 Participants
Age, Categorical Between 18 and 65 years	102 Participants n=102 Participants
Age, Categorical >=65 years	0 Participants n=102 Participants
Age, Continuous	52.0 years n=102 Participants
Sex: Female, Male Female	102 Participants n=102 Participants
Sex: Female, Male Male	0 Participants n=102 Participants
Region of Enrollment Croatia	102 Participants n=102 Participants
Body Mass Index	27 kg/m^2 n=102 Participants
Smoking status	44 Participants n=102 Participants
Waist circumference	91 cm n=102 Participants
Hips circumference	107 cm n=102 Participants
Systolic blood pressure	130 mmHg n=102 Participants
Diastolic blood pressure	85 mmHg n=102 Participants
Total cholesterol	61 mg/dL n=102 Participants
HDL cholesterol	1.5 mg/dL n=102 Participants
LDL cholesterol	4.1 mg/dL n=102 Participants
Anti-hypertensive therapy	35 Participants n=102 Participants
Triglicerydes	1.4 mm/L n=102 Participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Participants Who Received Informations About Lifestyle Change n=102 Participants 60-minute lecture titled "Change of lifestyle and nutrition habits to reduce cardiovascular risk": 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.
Ten Year Risk of Cardiovascular Disease (CVD)	2.9 percentage of risk Interval 2.2 to 3.6

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Participants Who Received Informations About Lifestyle Change n=102 Participants 60-minute lecture titled "Change of lifestyle and nutrition habits to reduce cardiovascular risk": 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.
Decisional Conflict (DC)	27 score on a scale Interval 25.0 to 30.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Participants Who Received Informations About Lifestyle Change n=102 Participants 60-minute lecture titled "Change of lifestyle and nutrition habits to reduce cardiovascular risk": 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.
State Hope	105 score on a scale Interval 102.0 to 108.0

SECONDARY outcome

Timeframe: Change from baseline waist circumference at 3 months

Outcome measures

Outcome measures
Measure	Participants Who Received Informations About Lifestyle Change n=102 Participants 60-minute lecture titled "Change of lifestyle and nutrition habits to reduce cardiovascular risk": 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.
Waist Circumference	89 cm Interval 87.0 to 92.0

SECONDARY outcome

Timeframe: Change from baseline hips circumference at 3 months

Outcome measures

Outcome measures
Measure	Participants Who Received Informations About Lifestyle Change n=102 Participants 60-minute lecture titled "Change of lifestyle and nutrition habits to reduce cardiovascular risk": 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.
Hips Circumference	107 cm Interval 105.0 to 110.0

SECONDARY outcome

Timeframe: Change from baseline weight at 3 months

Outcome measures

Outcome measures
Measure	Participants Who Received Informations About Lifestyle Change n=102 Participants 60-minute lecture titled "Change of lifestyle and nutrition habits to reduce cardiovascular risk": 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.
Weight	61 kg Interval 54.0 to 68.0

Adverse Events

Participants Who Received Informations About Lifestyle Change

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Slavica Jurić Petričević

University of Split School of Medicine

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place