Tobacco UseNCT01323023
A Study to Examine Health Behavior Change Strategies for Primary Care
An observational study of Tobacco Use and Risky Drinking, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Prescription for Health is a national program of The Robert Wood Johnson Foundation (RWJF) in collaboration with the Agency for Healthcare Research and Quality (AHRQ). A major goal of Prescription for Health is to measure the extent to which comprehensive strategies are effective in changing patient behavior and… Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use, Risky Drinking, Unhealthy Diet
- What is being tested?
- varies by project
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 4,463 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Jan 2013
- Phase
- Observational
- 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 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Adults, adolescents, and children in primary care practices.
Who may be able to join
- varies by project
Who cannot join
- varies by project
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado at Denver and Health Sciences Center
Aurora, Colorado, 80045
About this study
Official title: Common Measures, Better Outcomes (COMBO)
Prescription for Health is a national program of The Robert Wood Johnson Foundation (RWJF) in collaboration with the Agency for Healthcare Research and Quality (AHRQ). A major goal of Prescription for Health is to measure the extent to which comprehensive strategies are effective in changing patient behavior and quality of life relative to four target health risk behaviors: diet, smoking, alcohol use, and physical activity. The funded projects will use a common set of survey instruments to help measure outcomes and draw overarching conclusions across projects. This study will only be analyzing aggregated data and does not have responsibility for recruitment of patients, randomization (if applicable), or interventions. Individual project designs may differ.
Read the detailed description
The data will be collected by and submitted from up to 10 practice-based research networks over a two-year period. We will: 1) aggregate de-identified data and 2) analyze the aggregated data. We will not identify or recruit study subjects, administer surveys to patients, or conduct any interventions with patients or practices. The individual research networks will submit only de-identified data to a central data repository for subsequent analysis by us. Individual research networks will submit their own protocols for review by their IRBs in order to collect patient-specific data, conduct interventions, and submit de-identified data to our central repository.
By combining data from funded projects we will be able to answer questions that individual projects would not be able to answer. The analysis will use the combined set of data to gain statistical power sufficient to test hypotheses of interest, determine the distribution of responses to the selected measures in patients in primary care practices, assess the impact of types of interventions, compare the impact of different types of interventions, determine if these measures can be used routinely, and conclude how useful, if at all, the selected measures were in Prescription for Health projects. Statistical analysis will include basic descriptive statistics and distributions of scores at baseline and follow-up and more complex hierarchical linear modeling, which seeks to understand effects in multi-site studies (across sites or groups of sites). We will not directly evaluate specific research network interventions, but will assess them as part of larger groups. This study will report only aggregated results and will not name individual primary care practices or research networks.
- Conditions
- Tobacco Use, Risky Drinking, Unhealthy Diet, Physical Inactivity
- Being tested
- varies by project
- Medical subject headings
- Tobacco Use, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
varies by projectBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2011 (estimated)
- Study startJun 2005
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 4,463 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation, Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Douglas H Fernald, MA, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01323023
- Sponsor's protocol ID
- 05-0484
- Status last verified
- Sep 2015
- First submitted
- 13 Apr 2006
- Last updated
- 1 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Common Measures, Better Outcomes (COMBO)
- ClinicalTrials.gov ID
- NCT01323023
- Acronym / sponsor ID
- 05-0484
- Conditions
- Tobacco Use, Risky Drinking, Unhealthy Diet, Physical Inactivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,463 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation, Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Jun 2005
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 25 Mar 2011 (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.
Prescription for Health is a national program of The Robert Wood Johnson Foundation (RWJF) in collaboration with the Agency for Healthcare Research and Quality (AHRQ). A major goal of Prescription for Health is to measure the extent to which comprehensive strategies are effective in changing patient behavior and quality of life relative to four target health risk behaviors: diet, smoking, alcohol use, and physical activity. The funded projects will use a common set of survey instruments to help measure outcomes and draw overarching conclusions across projects. This study will only be analyzing aggregated data and does not have responsibility for recruitment of patients, randomization (if applicable), or interventions. Individual project designs may differ.
Detailed description
The data will be collected by and submitted from up to 10 practice-based research networks over a two-year period. We will: 1) aggregate de-identified data and 2) analyze the aggregated data. We will not identify or recruit study subjects, administer surveys to patients, or conduct any interventions with patients or practices. The individual research networks will submit only de-identified data to a central data repository for subsequent analysis by us. Individual research networks will submit their own protocols for review by their IRBs in order to collect patient-specific data, conduct interventions, and submit de-identified data to our central repository.
By combining data from funded projects we will be able to answer questions that individual projects would not be able to answer. The analysis will use the combined set of data to gain statistical power sufficient to test hypotheses of interest, determine the distribution of responses to the selected measures in patients in primary care practices, assess the impact of types of interventions, compare the impact of different types of interventions, determine if these measures can be used routinely, and conclude how useful, if at all, the selected measures were in Prescription for Health projects. Statistical analysis will include basic descriptive statistics and distributions of scores at baseline and follow-up and more complex hierarchical linear modeling, which seeks to understand effects in multi-site studies (across sites or groups of sites). We will not directly evaluate specific research network interventions, but will assess them as part of larger groups. This study will report only aggregated results and will not name individual primary care practices or research networks.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults, adolescents, and children in primary care practices.
Key inclusion criteria (1 listed)
- varies by project
Key exclusion criteria (1 listed)
- varies by project
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 |
|---|---|---|
| varies by project | Behavioural | – |
Primary outcome
Not reported in the source record.
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 1 Oct 2015.
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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.
Douglas H Fernald, MA principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tobacco Use and Risky Drinking, run by University of Colorado, Denver at 1 site in United States.
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 1 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 1 Oct 2015.