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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 440
- 试验地点
- 1
- 主要终点
- the level of progress in the stage of behavioral change
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
brief counseling interventions
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.
干预措施: brief counseling (Behavioral)
Control group
written informative material about healthy lifestyles
干预措施: brief counseling (Behavioral)
结局指标
主要结局
the level of progress in the stage of behavioral change
时间窗: one and three months after the intervention
Stages of change of Prochaska and DiClemente
次要结局
- proportion of smokers and risky alcohol drinker(one and three months after the intervention)