HypertensionNCT03020836
Evaluating Effective Methods for Referral for Smoking Cessation Counseling and High Blood Pressure Follow-up
A study testing Referral to smoking quit line in people with Hypertension and Smoking Cessation, run by Johns Hopkins University.
Trial summary
Investigators conducted a clinic-based study to determine the magnitude of uncontrolled hypertension and current smoking in eye doctor's offices and sought to determine if referral to care results in actions taken by the patient. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Smoking Cessation
- What is being tested?
- Referral to smoking quit line
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 473 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Jul 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients >18 years of age presenting to the glaucoma service and general eye service at Wilmer Eye Institute.
Who cannot join
- Non-English speakers
- Unable to provide written informed consent
About this study
Investigators conducted a clinic-based study to determine the magnitude of uncontrolled hypertension and current smoking in eye doctor's offices and sought to determine if referral to care results in actions taken by the patient.
Read the detailed description
Smoking and hypertension are two modifiable risk factors that are linked to highly prevalent chronic diseases such as diabetes and cardiovascular disease. The ophthalmology waiting room has the potential to be an effective point of intervention to provide referral to primary care in addition to health education on preventive health topics.
The investigators therefore, conducted a clinic-based study to determine the magnitude of uncontrolled hypertension and current smoking in eye doctor's offices and to determine if referral to care results in actions taken by the patient.
The investigators determined the proportion of patients who have elevated blood pressure. Patients were referred appropriately and the proportion of participants who followed the recommendation to meet with their primary care doctor for elevated blood pressure at 4-6 weeks and 8-10 weeks was determined. In addition, those who consented to be in the study and admitted to smoking cigarettes were offered smoking cessation assistance through a quit line. Investigators also followed up on cigarette smoking at 4-6 weeks and 8-10 weeks.
- Conditions
- Hypertension, Smoking Cessation
- Being tested
- Referral to primary care physician for hypertension control, Referral to smoking quit line
- Medical subject headings
- Hypertension, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Referral to primary care physician for hypertension controlBehavioural
Referral to primary care physician for hypertension control
Referral to smoking quit lineBehavioural
Referral to Maryland Tobacco/Smoking quit line for help with smoking cessation
| Study group | Role | What they receive |
|---|---|---|
| Hypertension patient referral | Other | Referral to primary care physician for hypertension control: Patients with uncontrolled hypertension were referred to a primary care physician for treatment. Receives: Behavioral: Referral to primary care physician for hypertension control |
| Smoking cessation patient referral | Other | Referral to smoking quit line: Patients that were current smokers were referred to the Maryland smoking cessation quit line if they were willing. Receives: Behavioral: Referral to smoking quit line |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with elevated blood pressure
Measured: 1 day (at study clinic visit)
Secondary outcomes (3)
Proportion of patients that are current smokers
Measured: 1 day (at study clinic visit)
Proportion of patients with elevated blood pressure that sought referral care
Measured: From study visit to 10 weeks after
Proportion of patients that were current smokers that sought referral quit line assistance
Measured: From study visit to 10 weeks after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study startApr 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 473 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David S. Friedman, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03020836
- Sponsor's protocol ID
- NA_00089710
- Status last verified
- Jan 2017
- First submitted
- 10 Jan 2017
- Last updated
- 13 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Effective Methods for Referral for Smoking Cessation Counseling and High Blood Pressure Follow-up
- ClinicalTrials.gov ID
- NCT03020836
- Acronym / sponsor ID
- NA_00089710
- Conditions
- Hypertension, Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 473 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 13 Jan 2017 (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.
Investigators conducted a clinic-based study to determine the magnitude of uncontrolled hypertension and current smoking in eye doctor's offices and sought to determine if referral to care results in actions taken by the patient.
Detailed description
Smoking and hypertension are two modifiable risk factors that are linked to highly prevalent chronic diseases such as diabetes and cardiovascular disease. The ophthalmology waiting room has the potential to be an effective point of intervention to provide referral to primary care in addition to health education on preventive health topics.
The investigators therefore, conducted a clinic-based study to determine the magnitude of uncontrolled hypertension and current smoking in eye doctor's offices and to determine if referral to care results in actions taken by the patient.
The investigators determined the proportion of patients who have elevated blood pressure. Patients were referred appropriately and the proportion of participants who followed the recommendation to meet with their primary care doctor for elevated blood pressure at 4-6 weeks and 8-10 weeks was determined. In addition, those who consented to be in the study and admitted to smoking cigarettes were offered smoking cessation assistance through a quit line. Investigators also followed up on cigarette smoking at 4-6 weeks and 8-10 weeks.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypertension patient referral | Other | Behavioral: Referral to primary care physician for hypertension controlReferral to primary care physician for hypertension control: Patients with uncontrolled hypertension were referred to a primary care physician for treatment. |
| Smoking cessation patient referral | Other | Behavioral: Referral to smoking quit lineReferral to smoking quit line: Patients that were current smokers were referred to the Maryland smoking cessation quit line if they were willing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients >18 years of age presenting to the glaucoma service and general eye service at Wilmer Eye Institute.
Key exclusion criteria (2 listed)
- Non-English speakers
- Unable to provide written informed consent
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 |
|---|---|---|
| Referral to primary care physician for hypertension controlReferral to primary care physician for hypertension control | Behavioural | Hypertension patient referral |
| Referral to smoking quit lineReferral to Maryland Tobacco/Smoking quit line for help with smoking cessation | Behavioural | Smoking cessation patient referral |
Primary outcome
Proportion of patients with elevated blood pressure
Time frame: 1 day (at study clinic visit)
3 secondary outcomes
Proportion of patients that are current smokers
Time frame: 1 day (at study clinic visit)
Proportion of patients with elevated blood pressure that sought referral care
Time frame: From study visit to 10 weeks after
Proportion of patients that were current smokers that sought referral quit line assistance
Time frame: From study visit to 10 weeks after
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 13 Jan 2017.
- Individual participant dataSharing planned: No
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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 Referral to smoking quit line in people with Hypertension and Smoking Cessation, run by Johns Hopkins University.
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 2 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 13 Jan 2017. 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?
Proportion of patients with elevated blood pressure (time frame: 1 day (at study clinic visit)). 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 13 Jan 2017.