- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02718872
Tobacco Cessation Training Program in Spanish-speaking Countries (FRUITFUL)
Development and Dissemination of a Tobacco Cessation Training Program for Healthcare Professionals in Spanish-speaking Countries
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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:
- to adapt the course to the reality of 3 Spanish-speaking low and middle income countries (Bolivia, Guatemala, and Paraguay) and;
- 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:
- participants' attitudes, knowledge and behaviors before and after the training and
- 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Health professionals of the participating centers
Exclusion Criteria:
- No exclusion criteria
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Tobacco cessation online training
Six hour smoking cessation online training addressed to health professionals from hospitals in 3 Latin American Countries.
Participants are monitored by local coordinators that act as champions.
They offer their assistance to log into the online platform, fill out the questionnaires, complete the evaluation, including other technical support.
Participants' progress is monitored in real time onto the web platform.
The project coordinator at ICO sends a report of the participants progress every other week to coordinators, and if necessary personal emails to motivate students to finish the course and complete the evaluations.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knowledge, attitudes, and behaviors of trainees
Time Frame: six month
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compliance with tobacco control policies in hospitals
Time Frame: one year
|
Score in the self-audit questionnaire,
|
one year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Crisitna Martínez, PhD, Institut Català d'Oncologia - Institut d'Investigació Biomèdica de Bellvitge - Universitat de Barcelona ICO-IDIBELL-UB
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FRUITFUL GB-13520139
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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