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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Risk Behavior

Intervention / Treatment
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* Behavioral: brief counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: brief counseling interventions<br>For 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. | Behavioral: brief counseling<br>* 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<br>|
| Placebo Comparator: Control group<br>written informative material about healthy lifestyles | Behavioral: brief counseling<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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counseling, behavioral therapy, tobacco, alcohol drinking