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Clinical Trials/NCT03521622
NCT03521622
Completed
N/A

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

Hospital Universitario San Ignacio1 site in 1 country440 target enrollmentApril 15, 2018
ConditionsRisk Behavior

Overview

Phase
N/A
Intervention
Not specified
Conditions
Risk Behavior
Sponsor
Hospital Universitario San Ignacio
Enrollment
440
Locations
1
Primary Endpoint
the level of progress in the stage of behavioral change
Status
Completed
Last Updated
2 years ago

Overview

Brief 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

Detailed 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.

Registry
clinicaltrials.gov
Start Date
April 15, 2018
End Date
May 30, 2020
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • proportion of smokers and risky alcohol drinker(one and three months after the intervention)

Study Sites (1)

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