Tobacco Cessation Training Program in Spanish-speaking Countries

Smoking Cessation Clinical Trial

— FRUITFUL  

Official title:

Development and Dissemination of a Tobacco Cessation Training Program for Healthcare Professionals in Spanish-speaking Countries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02718872
• Other study ID #: FRUITFUL GB-13520139
• Status: Completed
• Phase: N/A
• First received: February 2, 2016
• Last updated: December 21, 2016
• Start date: January 2015
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Institut Català d'Oncologia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Institut Català d'OncologiaParaguay: Instituto de Enfermedades Respiratoiras INERAM Prof. Dr. Juan Max BoettnerGuatemala: Instituto de Cancerología y Hospital Dr. Bernardo del ValleBolivia: Instituto Oncológico del Oriente Boliviano
• Study type: Interventional

Clinical Trial Summary

This project is responsive to the identified gap of lack of tobacco cessation training programs in Latin American & Caribbean countries. Currently, smoking rates in the Latin American and Caribbean region are high, and previous surveys show that health professionals do not have enough skills to help smokers to quit. In consequence, in absence of trained health professionals, many smokers who visit health care services are under-treated. The Fruitful Project aims to adapt an original on-line course developed in Spain to the reality of the three Latin American countries (Bolivia, Guatemala and Paraguay) and disseminate evidence-based tobacco cessation interventions among health care professionals.

Description:

Tobacco cessation training programs to treat tobacco dependence have measureable effects on patients' smoking. Tobacco consumption in low and middle income countries is increasing, but these countries usually lack measures to face the epidemic, including tobacco cessation training programs addressed to their health professionals and organizations.

Based on a previous online training program for hospital workers in Spain, the Fruitful Study aims are twofold:

1. to adapt the course to the reality of 3 Spanish-speaking low and middle income countries (Bolivia, Guatemala, and Paraguay) and;

2. to evaluate the effectiveness of the program among the participant hospitals and workers.

Investigators use a mixed methods design with a pre-post evaluation (quantitative approach) and in-depth interviews and focus groups (qualitative approach). The main outcomes will be:

1. participants' attitudes, knowledge and behaviors before and after the training and

2. the level of implementation of tobacco control policies within the hospitals before and after the training.

The theoretical framework for this project includes Card's adapting model and Roger's diffusion of innovations model.

This study will show whether it is possible to adapt an online course to the reality of developing countries. In addition, investigator will measure whether an online program will produce changes in tobacco control policies at the organizational level and increase the level of knowledge, attitudes and perception in tobacco cessation at participants' level.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Health professionals of the participating centers

Exclusion Criteria:

• No exclusion criteria

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Smoking
• Smoking Cessation

Intervention

Behavioral:
• Tobacco cessation online training
The original course has been developed in the online platform e-oncologia (http://www.e-oncologia.org/en/) based on the in-person courses offered during the last 10 years by the Tobacco Control Unit of the Catalan Institute of Oncology. The theoretical framework underpinning the training program is the Stages of Change Model and the curriculum was developed with the content of numerous meta-analysis and clinical practice guidelines. We created a fully referenced curriculum online, with feedback from an expert advisory group that oriented in the instructional design to ensure the course content was palatable for an online format and aligned with the learning objectives. The final curriculum content of the "Brief Intervention for Smoking Cessation Training Program" is composed of 4 modules.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Institut Català d'Oncologia	Instituto de Cancerología y Hospital Dr. Bernardo del Valle, Instituto de Enfermedades Respiratoiras INERAM Prof. Dr. Juan Max Boettner, Instituto Oncológico del Oriente Boliviano

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knowledge, attitudes, and behaviors of trainees	Trainers' attitudes, knowledge and behaviors will be assessed by using a questionnaire composed of 63-items. The web-site delivered questionnaire is e-mailed to the participants at baseline and 6 months after finishing the training. The questionnaire takes 30-40 minutes to complete. It has been designed according to Sheffer work. The questionnaire gathers information about the provider gender, tobacco use history, previous tobacco cessation education, level of proactivity addressing tobacco use, and perceived success in helping patients stop using tobacco.	six month	No
Secondary	Compliance with tobacco control policies in hospitals	Score in the self-audit questionnaire,	one year	No

External Links

•   News about the project