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

Not Applicable
Completed
Conditions
Risk Behavior
Interventions
Behavioral: brief counseling
Registration Number
NCT03521622
Lead Sponsor
Hospital Universitario San Ignacio
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
440
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
brief counseling interventionsbrief counselingFor smoking patients the brief intervention is 5 As model for motivated patients and 5Rs for not motivated patients. For risky alcohol drinkers the brief intervention is simple advise for motivated patients and brief intervention for not motivated patients.
Control groupbrief counselingwritten informative material about healthy lifestyles
Primary Outcome Measures
NameTimeMethod
the level of progress in the stage of behavioral changeone and three months after the intervention

Stages of change of Prochaska and DiClemente

Secondary Outcome Measures
NameTimeMethod
proportion of smokers and risky alcohol drinkerone and three months after the intervention

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

Trial Locations

Locations (1)

Hospital Universitario de San Ignacio

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Bogotá, Distrito Capital, Colombia

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