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

Sponsor

Hospital Universitario San Ignacio (Other)

Overall Status

Unknown status

CT.gov ID

NCT03521622

Collaborator

Pontificia Universidad Javeriana (Other)

440

Enrollment

Location

Arms

29.5

Anticipated Duration (Months)

14.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Risk Behavior	Behavioral: brief counseling	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

440 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Screening

Official 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

Actual Study Start Date :

Apr 15, 2018

Actual Primary Completion Date :

May 30, 2019

Anticipated Study Completion Date :

Sep 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: brief counseling 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
Placebo Comparator: Control group written informative material about healthy lifestyles	Behavioral: brief counseling 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

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: brief counseling

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

Placebo Comparator: Control group

written informative material about healthy lifestyles

Behavioral: brief counseling

Outcome Measures

Primary Outcome Measures

the level of progress in the stage of behavioral change [one and three months after the intervention]
Stages of change of Prochaska and DiClemente

Secondary Outcome Measures

proportion of smokers and risky alcohol drinker [one and three months after the intervention]
proportion of smokers and risky alcohol drinker in each arm of the study

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario de San Ignacio	Bogotá	Distrito Capital	Colombia

Sponsors and Collaborators

Hospital Universitario San Ignacio
Pontificia Universidad Javeriana

Investigators

Principal Investigator: Luz H Alba, MD, Hospital San Ignacio

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospital Universitario San Ignacio

ClinicalTrials.gov Identifier:

NCT03521622

Other Study ID Numbers:

2018/07

First Posted:

May 11, 2018

Last Update Posted:

Aug 5, 2020

Last Verified:

Aug 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hospital Universitario San Ignacio

Study Results

No Results Posted as of Aug 5, 2020