Intervention (Training) ConditionWeBREATHe IINCT01642264
Web-Based Respiratory Education About Tobacco and Health Phase II
A study testing WeBREATHe Training Program in people with Intervention (Training) Condition and Control (Delayed Training) Condition, run by Oregon Research Institute.
Trial summary
The primary aim of this study was to develop an interactive Internet-based program (WeBREATHe: Web-Based Respiratory Education About Tobacco and Health) to train pediatric respiratory therapists and nurses to provide brief, hospital-based tobacco cessation interventions to parents of pediatric patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intervention (Training) Condition, Control (Delayed Training) Condition
- What is being tested?
- WeBREATHe Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Dec 2010
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be a respiratory Therapist, nurse or nurse practitioner at the 2 pediatric hospitals participating in the study.
- Must be at least 18 years of age.
Who cannot join
- Under 18 years of age.
About this study
Official title: Web-Based Respiratory Education About Tobacco and Health (WeBREATHe) Phase II
The primary aim of this study was to develop an interactive Internet-based program (WeBREATHe: Web-Based Respiratory Education About Tobacco and Health) to train pediatric respiratory therapists and nurses to provide brief, hospital-based tobacco cessation interventions to parents of pediatric patients. The WeBREATHe program was based on a Phase I prototype which was evaluated with 50 pediatric respiratory therapists and nurses.
In Phase II, the investigators redesigned and expanded the program with input from 50 educators, nurses and respiratory therapists from Cincinnati Children's Hospital Medical Center. Then the investigators evaluated the Phase II program in a randomized trial in which 215 respiratory therapists and nurses from two large, urban children's hospitals were randomly assigned within hospital to either the Intervention (Training) Condition, or to a Delayed Treatment (Training) Control condition.
Read more
Participants' demographic and tobacco use history were measured at baseline, and tobacco cessation intervention behaviors, attitudes, knowledge, perceived barriers, and self-efficacy regarding delivery of a tobacco cessation intervention were measured at baseline, 1 week post-training, and at 3 months post-training. User satisfaction measures were also collected at 1 week post-training from Intervention Condition participants. The investigators hypothesized that participants in the Intervention Condition would have increased tobacco cessation behaviors, positive attitudes and self-efficacy, and decreased perceived barriers than participants i the Delayed-Treatment Control Condition.
Following evaluation, the investigators developed a final version of the interactive training program and created the administrative infrastructure for a marketable product.
- Being tested
- WeBREATHe Training Program
- Keywords
- Tobacco Cessation, Continuing Education, Pediatric, Respiratory Therapist, Nurse
- Medical subject headings
- Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WeBREATHe Training ProgramBehavioural
The WeBREATHe Training Program is a web-based, interactive training program to teach pediatric respiratory therapists, nurses and nurse practitioners how to help their patients' parents to quit smoking.
| Study group | Role | What they receive |
|---|---|---|
| Control (Delayed Training) Condition | No intervention | Participants in this condition were assessed at 1 week, 1 month and 3 months post-enrollment, and were provided access to the WeBREATHe training website upon completion of their 3-month assessment. |
| Intervention (Training) Condition | Experimental | In this condition, participants used the WeBREATHe training program website for 1 week, and completed assessments at 1 week, 1 month, and 3 months post-training. Receives: Behavioral: WeBREATHe Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of Ask, Advise, Assess, Assist and Arrange Behaviors
14 items measured on a 5-point Likert scale of frequency. Ask = asking all patients' parents about tobacco use and documenting use in the patients' charts.
Advise = discussing health hazards of tobacco use and giving direct advice to quit.
Assess = determining parents' level of readiness to quit. Assist = discussing strategies or techniques to quit, setting a specific date to quit, discussing pharmacotherapy for tobacco cessation, giving written self-help materials to tobacco users.
Arrange = discussing local tobacco cessation resources and making a referral to a tobacco quit line.
Measured: 3 months post-enrollment
Secondary outcomes (3)
Attitudes towards provision of tobacco cessation interventions
9 items. Level of agreement measured on a 5-point Likert scale on 9 statements measuring attitudes towards provision of tobacco cessation interventions to patients' parents in pediatric settings. For example, "It is appropriate for pediatric RTs and RNs to assess and document their patients' exposure to secondhand smoke (e.g., family members' tobacco use)."
Measured: 3 months post-enrollment
Perceived Barriers
7 items measured on a 5-point Likert scale. Participants rate the level of routine barriers to provision of tobacco cessation interventions in pediatric settings, (e.g., lack of training, lack of time, lack of resources).
Measured: 3 months post-enrollment
Self-Efficacy
6 items measured on a 5-point Likert scale. Participants rate their agreement to statements of perceived self-efficacy to perform Ask, Advise, Assess, Assist and Arrange behaviors (e.g., "I can ask my patients' parents about their smoking.")
Measured: 3 months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startMar 2008
- Primary completionNov 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intervention (Training) ConditionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01642264
- Sponsor's protocol ID
- HL083540
- Acronym
- WeBREATHe II
- Status last verified
- Sep 2023
- First submitted
- 11 Jul 2012
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-Based Respiratory Education About Tobacco and Health (WeBREATHe) Phase II
- ClinicalTrials.gov ID
- NCT01642264
- Acronym / sponsor ID
- WeBREATHe II / HL083540
- Keywords
- Tobacco Cessation, Continuing Education, Pediatric, Respiratory Therapist, Nurse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 17 Jul 2012 (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.
The primary aim of this study was to develop an interactive Internet-based program (WeBREATHe: Web-Based Respiratory Education About Tobacco and Health) to train pediatric respiratory therapists and nurses to provide brief, hospital-based tobacco cessation interventions to parents of pediatric patients. The WeBREATHe program was based on a Phase I prototype which was evaluated with 50 pediatric respiratory therapists and nurses.
In Phase II, the investigators redesigned and expanded the program with input from 50 educators, nurses and respiratory therapists from Cincinnati Children's Hospital Medical Center. Then the investigators evaluated the Phase II program in a randomized trial in which 215 respiratory therapists and nurses from two large, urban children's hospitals were randomly assigned within hospital to either the Intervention (Training) Condition, or to a Delayed Treatment (Training) Control condition.
Participants' demographic and tobacco use history were measured at baseline, and tobacco cessation intervention behaviors, attitudes, knowledge, perceived barriers, and self-efficacy regarding delivery of a tobacco cessation intervention were measured at baseline, 1 week post-training, and at 3 months post-training. User satisfaction measures were also collected at 1 week post-training from Intervention Condition participants. The investigators hypothesized that participants in the Intervention Condition would have increased tobacco cessation behaviors, positive attitudes and self-efficacy, and decreased perceived barriers than participants i the Delayed-Treatment Control Condition.
Following evaluation, the investigators developed a final version of the interactive training program and created the administrative infrastructure for a marketable product.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control (Delayed Training) Condition | No intervention | –Participants in this condition were assessed at 1 week, 1 month and 3 months post-enrollment, and were provided access to the WeBREATHe training website upon completion of their 3-month assessment. |
| Intervention (Training) Condition | Experimental | Behavioral: WeBREATHe Training ProgramIn this condition, participants used the WeBREATHe training program website for 1 week, and completed assessments at 1 week, 1 month, and 3 months post-training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Must be a respiratory Therapist, nurse or nurse practitioner at the 2 pediatric hospitals participating in the study.
- Must be at least 18 years of age.
Key exclusion criteria (1 listed)
- Under 18 years of age.
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 |
|---|---|---|
| WeBREATHe Training ProgramThe WeBREATHe Training Program is a web-based, interactive training program to teach pediatric respiratory therapists, nurses and nurse practitioners how to help their patients' parents to quit smoking. | Behavioural | Intervention (Training) Condition |
Primary outcome
Performance of Ask, Advise, Assess, Assist and Arrange Behaviors
Time frame: 3 months post-enrollment
14 items measured on a 5-point Likert scale of frequency. Ask = asking all patients' parents about tobacco use and documenting use in the patients' charts. Advise = discussing health hazards of tobacco use and giving direct advice to quit. Assess = determining parents' level of readiness to quit. Assist = discussing strategies or techniques to quit, setting a specific date to quit, discussing pharmacotherapy for tobacco cessation, giving written self-help materials to tobacco users. Arrange = discussing local tobacco cessation resources and making a referral to a tobacco quit line.
3 secondary outcomes
Attitudes towards provision of tobacco cessation interventions
Time frame: 3 months post-enrollment
Perceived Barriers
Time frame: 3 months post-enrollment
Self-Efficacy
Time frame: 3 months post-enrollment
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 26 Sep 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing WeBREATHe Training Program in people with Intervention (Training) Condition and Control (Delayed Training) Condition, run by Oregon Research Institute.
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 2 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 26 Sep 2023. 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?
Performance of Ask, Advise, Assess, Assist and Arrange Behaviors (time frame: 3 months post-enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Sep 2023.