Effectiveness of Counseling Interventions to Modify Risk Behaviors in Patients at the Hospital San Ignacio.

Risk Behavior Clinical Trial

— EFICO  

Official title:

Effectiveness of Counseling Interventions to Modify the Stage of Behavioral Change in Risk Behaviors (Smoking and Risky Alcohol Consumption) of Patient's Candidates for Surgery at the Hospital San Ignacio. Bogotá-Colombia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03521622
• Other study ID #: 2018/07
• Status: Completed
• Phase: N/A
• Start date: April 15, 2018
• Est. completion date: May 30, 2020

Study information

• Verified date: March 2024
• Source: Hospital Universitario San Ignacio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized clinical trial that aims to determine the effectiveness of a counseling intervention to modify the stage of behavioral change in risk behaviors (smoking and risky alcohol consumption) in patients candidates for scheduled surgery or diagnostic procedures at the Hospital Universitario de San Ignacio. Bogotá-Colombia

Description:

Objective: to determine the effect in the behavioral change stage of an intervention to modify risk behaviors (smoking and risky alcohol consumption) in patients candidates for scheduled surgery or diagnostic procedures at the Hospital Universitario de San Ignacio. Design: controlled clinical trial with random assignment Population: patients candidates for scheduled surgery or diagnostic procedures in surgery rooms between 19 and 64 years attending the pre-anesthetic consultation of the Hospital Universitario de San Ignacio. Interventions: brief behavioral intervention to modify risk behaviors versus information material on healthy lifestyles. Measurements: the characteristics of the study population will be described and the intervention and control groups will be compared in their basic conditions. The level of advance in the stage of change in the intervention and control arm, the proportion of people with the presence of the risk factor, as well as the decrease in the consumption of tobacco and alcohol will be compared. Expected duration: 28 months. Financing: Hospital Universitario de San Ignacio and Pontificia Universidad Javeriana. Ethical aspects: the study is adjusted to international and national standards for research projects. Under this norm, it is classified in the category of minimum risk because it is a clinical experiment with a common intervention in clinical practice.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 440
• Est. completion date: May 30, 2020
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 64 Years

Eligibility

Inclusion Criteria:

• candidates for scheduled surgery with a hospital stay of 3 days or less (including ambulatory surgeries) or who attend outpatient diagnostic procedures performed in surgery rooms.

• Current smokers (any tobacco product in the last month and more than 100 cigarretes in life) or risky alcohol drinkers (more than 4 or 5 alcohol standard drinks during the last year and AUDIT score between 8-15 points)

• patients with contact information

• Patients that want to participate

Exclusion Criteria:

• People who are being treated for smoking cessation or decreased consumption of alcohol.

• People with diseases that compromise their ability to understand information or their ability to verbal communication

• Patients with dependence or abuse of alcohol or other psychoactive substances other than tobacco

• Patients in action or maintenance stages of behavioral change against their risk factor

Related Conditions & MeSH terms

• Risk Behavior

Intervention

Behavioral:
• brief counseling
Brief counseling for motivated smoker 5 As model Brief counseling for not motivated smokers 5 Rs model Brief counseling for motivated risky drinkers simple advice Brief counseling for not motivated risky drinkers brief alcohol intervention

Locations

Country	Name	City	State
Colombia	Hospital Universitario de San Ignacio	Bogotá	Distrito Capital

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitario San Ignacio	Pontificia Universidad Javeriana

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the level of progress in the stage of behavioral change	Stages of change of Prochaska and DiClemente	one and three months after the intervention
Secondary	proportion of smokers and risky alcohol drinker	proportion of smokers and risky alcohol drinker in each arm of the study	one and three months after the intervention