NCT03521622

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
440

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2018

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
Last Updated

March 13, 2024

Status Verified

March 1, 2024

Enrollment Period

1.1 years

First QC Date

April 30, 2018

Last Update Submit

March 12, 2024

Conditions

Risk Behavior

Keywords

counselingbehavioral therapytobaccoalcohol drinking

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • proportion of smokers and risky alcohol drinker

    one and three months after the intervention

Study Arms (2)

brief counseling interventions

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

written informative material about healthy lifestyles

Behavioral: brief counseling

Interventions

brief counselingBEHAVIORAL

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

Control groupbrief counseling interventions

Eligibility Criteria

Age19 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario de San Ignacio

Bogotá, Bogota D.C., Colombia

Location

Related Publications (2)

  • Ingrid A, Olaya L, Cuevas V, Castillo JS, Becerra N, Delgado J, Canas A, Alba LH. Effectiveness of brief counselling in a hospital setting for smoking cessation and risky alcohol drinking reduction: randomised clinical trial protocol. Rev Colomb Psiquiatr (Engl Ed). 2022 Apr-Jun;51(2):146-152. doi: 10.1016/j.rcpeng.2020.06.003. Epub 2022 Jun 16. English, Spanish.

    PMID: 35717385DERIVED

  • Almonacid I, Olaya L, Cuevas V, Castillo JS, Becerra N, Delgado J, Canas A, Alba LH. Effectiveness of Brief Counseling in a Hospital Setting for Smoking Cessation and Risky Alcohol Drinking Reduction: Randomized Clinical Trial Protocol. Rev Colomb Psiquiatr (Engl Ed). 2020 Nov 12:S0034-7450(20)30085-8. doi: 10.1016/j.rcp.2020.06.005. Online ahead of print. English, Spanish.

    PMID: 33735015DERIVED

MeSH Terms

Conditions

Risk-TakingAlcohol Drinking

Condition Hierarchy (Ancestors)

BehaviorDrinking Behavior

Study Officials

  • Luz H Alba, MD

    Hospital San Ignacio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2018

First Posted

May 11, 2018

Study Start

April 15, 2018

Primary Completion

May 30, 2019

Study Completion

May 30, 2020

Last Updated

March 13, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

CO(1)