SmokingFRUITFULNCT02718872
Tobacco Cessation Training Program in Spanish-speaking Countries
A study testing Tobacco cessation online training in people with Smoking and Smoking Cessation, run by Institut Català d'Oncologia.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Smoking Cessation
- What is being tested?
- Tobacco cessation online training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Health professionals of the participating centers
Who cannot join
- No exclusion criteria
About this study
Official title: Development and Dissemination of a Tobacco Cessation Training Program for Healthcare Professionals in Spanish-speaking Countries
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.
Read the 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.
- Conditions
- Smoking, Smoking Cessation
- Being tested
- Tobacco cessation online training
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobacco cessation online trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Tobacco cessation online training | Experimental | 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. Receives: Behavioral: Tobacco cessation online training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: six month
Secondary outcomes (1)
Compliance with tobacco control policies in hospitals
Score in the self-audit questionnaire,
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study startJan 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Català d'Oncologia
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Oncológico del Oriente Boliviano, Instituto de Cancerología y Hospital Dr. Bernardo del Valle, Instituto de Enfermedades Respiratoiras INERAM Prof. Dr. Juan Max Boettner
- Responsible party
- Principal investigator, Cristina Martínez Martínez, Institut Català d'Oncologia
- Investigators
- Crisitna Martínez, PhD, Principal investigator, Institut Català d'Oncologia - Institut d'Investigació Biomèdica de Bellvitge - Universitat de Barcelona ICO-IDIBELL-UB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02718872
- Sponsor's protocol ID
- FRUITFUL GB-13520139
- Acronym
- FRUITFUL
- Status last verified
- Dec 2016
- First submitted
- 2 Feb 2016
- Last updated
- 22 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: NO plans for data sharing
Publications
Martinez C, Company A, Guillen O, Margalef M, Arrien MA, Sanchez C, Caceres de Leon P, Fernandez E; Group of Hospital Coordinators in the Fruitful Project. Adaptation, Implementation Plan, and Evaluation of an Online Tobacco Cessation Training Program for Health Care Professionals in Three Spanish-Speaking Latin American Countries: Protocol of the Fruitful Study. JMIR Res Protoc. 2017 Jan 27;6(1):e7. doi: 10.2196/resprot.6487.
PubMed 28128731
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Dissemination of a Tobacco Cessation Training Program for Healthcare Professionals in Spanish-speaking Countries
- ClinicalTrials.gov ID
- NCT02718872
- Acronym / sponsor ID
- FRUITFUL / FRUITFUL GB-13520139
- Conditions
- Smoking, Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Institut Català d'OncologiaUniversity, hospital or other
- Collaborators
- Instituto Oncológico del Oriente Boliviano, Instituto de Cancerología y Hospital Dr. Bernardo del Valle, Instituto de Enfermedades Respiratoiras INERAM Prof. Dr. Juan Max Boettner
- Study start
- Jan 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 24 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tobacco cessation online training | Experimental | Behavioral: Tobacco cessation online trainingSix 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Health professionals of the participating centers
Key exclusion criteria (1 listed)
- No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tobacco cessation online trainingThe 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. | Behavioural | Tobacco cessation online training |
Primary outcome
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.
1 secondary outcome
Compliance with tobacco control policies in hospitals
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2016.
- Derived from this study: PubMed 28128731Martinez C, Company A, Guillen O, Margalef M, Arrien MA, Sanchez C, Caceres de Leon P, Fernandez E; Group of Hospital Coordinators in the Fruitful Project. Adaptation, Implementation Plan, and Evaluation of an Online Tobacco Cessation Training Program for Health Care Professionals in Three Spanish-Speaking Latin American Countries: Protocol of the Fruitful Study. JMIR Res Protoc. 2017 Jan 27;6(1):e7. doi: 10.2196/resprot.6487.
- Individual participant dataSharing planned: No. NO plans for data sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Crisitna Martínez, PhD principal investigator
Institut Català d'Oncologia - Institut d'Investigació Biomèdica de Bellvitge - Universitat de Barcelona ICO-IDIBELL-UB
Questions about this trial
What is this clinical trial studying?
A study testing Tobacco cessation online training in people with Smoking and Smoking Cessation, run by Institut Català d'Oncologia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge, attitudes, and behaviors of trainees (time frame: six month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02718872, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2016.