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

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ClinicalTrials.gov Identifier: NCT03521622
Recruitment Status : Recruiting
First Posted : May 10, 2018
Last Update Posted : June 4, 2018
Sponsor:
Collaborator:
Pontificia Universidad Javeriana
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Risk Behavior Behavioral: brief counseling Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 30, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. proportion of smokers and risky alcohol drinker [ Time Frame: one and three months after the intervention ]
    proportion of smokers and risky alcohol drinker in each arm of the study



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03521622


Contacts
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Contact: Luz H Alba, MD 57(1)3208320 ext 2849 lalba@javeriana.edu.co
Contact: María M Manrique, MD 57(1)5946161 ext 2475 mmmanrique@husi.org.co

Locations
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Colombia
Hospital Universitario de San Ignacio Recruiting
Bogotá, Distrito Capital, Colombia
Contact: Luz Helena Alba, MD    57-3102452740    lhalba@husi.org.co   
Sponsors and Collaborators
Hospital Universitario San Ignacio
Pontificia Universidad Javeriana
Investigators
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Principal Investigator: Luz H Alba, MD Hospital San Ignacio

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Responsible Party: Hospital Universitario San Ignacio
ClinicalTrials.gov Identifier: NCT03521622     History of Changes
Other Study ID Numbers: 2018/07
First Posted: May 10, 2018    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospital Universitario San Ignacio:
counseling
behavioral therapy
tobacco
alcohol drinking

Additional relevant MeSH terms:
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Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs