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Completed

NCT Number: NCT03521622

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

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

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Key information

Age range

19 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario de San Ignacio

Bogotá, Bogota D.C., Colombia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief Counseling

Behavioral

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

Primary outcomes

  1. the level of progress in the stage of behavioral change

    Time frame: one and three months after the intervention

    Stages of change of Prochaska and DiClemente

Secondary outcomes

  1. proportion of smokers and risky alcohol drinker

    Time frame: one and three months after the intervention

    proportion of smokers and risky alcohol drinker in each arm of the study

Sponsors and collaborators

Lead sponsor

Hospital Universitario San Ignacio

Other

Collaborators

  • Pontificia Universidad Javeriana

Registry information

Official study 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

Acronym: EFICO

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
May 11, 2018
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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