Training Methods for a Doctrine Of Life With Healthy Heart

Heart Diseases Clinical Trial

Official title:

Two Distinct Training Methods for Healthy Heart in Low Social and Economical Society

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00738231
• Other study ID #: 2007/37
• Status: Enrolling by invitation
• Phase: N/A
• First received: August 19, 2008
• Last updated: June 18, 2009
• Start date: September 2007
• Est. completion date: December 2009

Study information

• Verified date: August 2008
• Source: Eskisehir Osmangazi University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This study is an interventional study which was conducted in the field. The investigators intended to develop an efficient and economically valuable method which can decrease the risk factors for prevention of cardiovascular diseases. Effective control of cardiovascular diseases necessitates a salutogenetic approach to develop efficient and cheap methods to decrease risk factors.

In this study, the aim of preparing the Group II training material was to enable the individual to see his or her risks as unique, and to proceed with life by adapting personal behaviors. Group II's training material was formatted as a prescription. Because giving a prescription for a doctor is very important in low socioeconomical group person.

This study showed that social programs oriented towards individual behavioral changes assume an important role in decreasing cardiovascular risk factors.

Description:

Background:

Effective control of cardiovascular diseases necessitates a salutogenetic approach to develop efficient and economical methods to decrease risk factors.

Methods:

This study was conducted in three stages in a semi-rural region of Eskisehir, Turkey. In the first stage, individuals selected by random sampling were evaluated in terms of social-demographic characteristics and the risk factors present for cardiovascular diseases. A scale comprised of 19 questions was implemented for data assessment. In the second stage, training materials were randomly distributed. Group I's training material consisted of a brochure containing pictures and general information on heart disease; Group II members additionally received a personalized letter that further explained their individual risk factors and suggested measures for increased protection and prevention - in short, Group II's training material was formatted as a prescription. In the third stage, the subjects were screen against the cardiovascular risks factors one year later to assess and determine if there had been any changes in their attitudes towards the dangers of the cardiovascular diseases.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 498
• Est. completion date: December 2009
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Over 40 years of age were contacted.

• Individuals who were literate or had at least one literate person in the household were selected through random sampling via the records of local health care units.

Exclusion Criteria:

• Under 40 years of age and immigrants

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Heart Diseases

Intervention

Behavioral:
• Training
The training materials were randomly distributed to study participant groups. The list of names was systematically divided into two groups: odd-numbered individuals were given brochures only, and even-numbered individuals were given both letters and brochures. Since we could not have prevented an illustrated material to be passed by in a closed environment, it was deemed appropriate to distribute both the letter and brochure instead of just the brochure.
• Training
The training materials were randomly distributed to study participant groups. The list of names was systematically divided into two groups: odd-numbered individuals were given brochures only, and even-numbered individuals were given both letters and brochures. Since we could not have prevented an illustrated material to be passed by in a closed environment, it was deemed appropriate to distribute both the letter and brochure instead of just the brochure.

Locations

Country	Name	City	State
Turkey	ESOGU	Eskisehir

Sponsors (1)

Lead Sponsor	Collaborator
Eskisehir Osmangazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase of score of the knowledge about the risk factors for cardiovascular diseases		1 month	Yes
Secondary	Stop smoking; to regulate of arterial tension; properly change of feeding behaviour		1 year	Yes

External Links

•   Eskisehir Osmangazi University