Smoking CessationNCT04928781
Smoking Cessation Study
A study testing Smoking Cessation Counseling in people with Smoking Cessation, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
This is a pilot study to determine the feasibility and success of offering smoking cessation counseling for ambulatory patients who present for scheduled cardiac catheterization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Smoking Cessation Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2022to 1 Jun 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presents to Dartmouth-Hitchcock Medical Center in Lebanon, NH as an ambulatory patient with a scheduled cardiac Catheterization
- smoke one or more cigarettes per day for the past 12 months OR use of electronic-cigarettes containing tobacco at least once during the past 30 days.
- proficient in English
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Smoking Cessation Intervention for Hospitalized Heart & Vascular Center (HVC) Patients at a Dartmouth-Hitchcock Medical Center Serving a Rural Population
This is a pilot study to determine the feasibility and success of offering smoking cessation counseling for ambulatory patients who present for scheduled cardiac catheterization.
Read the detailed description
This is a prospective randomized pilot study of feasibility and success of smoking cessation counselling for ambulatory patients who present for scheduled cardiac catheterization. Patients who meet inclusion and exclusion criteria will be eligible for enrollment and receive smoking cessation counseling. Patients will be followed for 6 months post intervention. A Usual care arm will be created using retrospective chart review.
- Conditions
- Smoking Cessation
- Being tested
- Smoking Cessation Counseling
- Keywords
- Percutaneous Coronary Intervention
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking Cessation CounselingBehavioural
Smoking cessation counseling will be provided following standards set by the institution patients are receiving care at (Dartmouth-Hitchcock Medical Center).
| Study group | Role | What they receive |
|---|---|---|
| Smoking Cessation Counseling - Intervention Arm | Experimental | Intervention arm. All patients enrolled in the study will be provided with smoking cessation counseling. Receives: Behavioral: Smoking Cessation Counseling |
| Retrospective Chart Review - Control Arm | No intervention | Control arm. A retrospective chart review will be conducted to create a randomly selected cohort of patients that meet inclusion and exclusion criteria and did not receive smoking cessation counseling to serve as the control arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants that self-report sustained smoking cessation
Percentage of participants that self report sustained smoking cessation at 1 month.
Measured: 1 month post index procedure
Percentage of participants that self-report sustained smoking cessation
Percentage of participants that self report sustained smoking cessation at 3 months.
Measured: 3 months post index procedure
Percentage of participants that self-report sustained smoking cessation
Percentage of participants that self report sustained smoking cessation at 6 months.
Measured: 6 months post index procedure
Secondary outcomes (12)
Percentage of participants that have had at least one subsequent cardiovascular hospital admission.
Percentage of participants that have had at least one subsequent cardiovascular hospital admission at 1 month post index procedure.
Measured: 1 month post index procedure
Percentage of participants that have had at least one subsequent cardiovascular hospital admission.
Percentage of participants that have had at least one subsequent cardiovascular hospital admission at 3 months post index procedure.
Measured: 3 months post index procedure
Percentage of participants that have had at least one subsequent cardiovascular hospital admission.
Percentage of participants that have had at least one subsequent cardiovascular hospital admission at 6 months post index procedure.
Measured: 6 months post index procedure
Percentage of participants that have had at least one emergency department presentation
Percentage of participants that have had at least one emergency department presentation following discharge for their index procedure 1 month post index procedure
Measured: 1 month post index procedure
Percentage of participants that have had at least one emergency department presentation
Percentage of participants that have had at least one emergency department presentation following discharge for their index procedure 3 months post index procedure
Measured: 3 months post index procedure
Percentage of participants that have had at least one emergency department presentation
Percentage of participants that have had at least one emergency department presentation following discharge for their index procedure 6 months post index procedure
Measured: 6 months post index procedure
Frequency of Cardiac Events following discharge from index procedure
Frequency of cardiac events following discharge from hospitals, 1 month after index procedure.
Measured: 1 month post index procedure
Frequency of Cardiac Events following discharge from index procedure
Frequency of cardiac events following discharge from hospitals, 3 months after index procedure.
Measured: 3 months post index procedure
Frequency of Cardiac Events following discharge from index procedure
Frequency of cardiac events following discharge from hospitals, 6 months after index procedure.
Measured: 6 months post index procedure
Percentage of participants that need subsequent coronary intervention following index procedure
Percentage of participants that need subsequent coronary intervention following index procedure at 1 month post index procedure
Measured: 1 month post index procedure
Percentage of participants that need subsequent coronary intervention following index procedure
Percentage of participants that need subsequent coronary intervention following index procedure at 3 months post index procedure
Measured: 3 moths post index procedure
Percentage of participants that need subsequent coronary intervention following index procedure
Percentage of participants that need subsequent coronary intervention following index procedure at 6 months post index procedure
Measured: 6 months post index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start28 Jun 2022 (estimated)
- Primary completion1 Feb 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Why it stopped: PI and funding source collectively decided to close study due to lack of smoking cessation counselor required for study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 2 arm study, with a control arm and intervention arm. The control arm will consist of a retrospective chart review will be conducted to create a randomly selected cohort of patients that meet inclusion and exclusion criteria and did not receive smoking cessation counseling to serve as the control arm. The intervention arm will prospectively enroll to be provided with smoking cessation counseling.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merle L. Myerson, Dartmouth-Hitchcock Medical Center
- Investigators
- Merle L Myerson, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928781
- Sponsor's protocol ID
- STUDY02000943
- Status last verified
- Feb 2023
- First submitted
- 2 Jun 2021
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No Plant to share individual participant data (IPD) exists at this time.
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Cessation Intervention for Hospitalized Heart & Vascular Center (HVC) Patients at a Dartmouth-Hitchcock Medical Center Serving a Rural Population
- ClinicalTrials.gov ID
- NCT04928781
- Acronym / sponsor ID
- STUDY02000943
- Conditions
- Smoking Cessation
- Keywords
- Percutaneous Coronary Intervention
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI and funding source collectively decided to close study due to lack of smoking cessation counselor required for study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 28 Jun 2022 (estimated)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 16 Jun 2021 (actual)
- 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 is a pilot study to determine the feasibility and success of offering smoking cessation counseling for ambulatory patients who present for scheduled cardiac catheterization.
Detailed description
This is a prospective randomized pilot study of feasibility and success of smoking cessation counselling for ambulatory patients who present for scheduled cardiac catheterization. Patients who meet inclusion and exclusion criteria will be eligible for enrollment and receive smoking cessation counseling. Patients will be followed for 6 months post intervention. A Usual care arm will be created using retrospective chart review.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 arm study, with a control arm and intervention arm. The control arm will consist of a retrospective chart review will be conducted to create a randomly selected cohort of patients that meet inclusion and exclusion criteria and did not receive smoking cessation counseling to serve as the control arm. The intervention arm will prospectively enroll to be provided with smoking cessation counseling.
| Arm | Type | Receives |
|---|---|---|
| Smoking Cessation Counseling - Intervention Arm | Experimental | Behavioral: Smoking Cessation CounselingIntervention arm. All patients enrolled in the study will be provided with smoking cessation counseling. |
| Retrospective Chart Review - Control Arm | No intervention | –Control arm. A retrospective chart review will be conducted to create a randomly selected cohort of patients that meet inclusion and exclusion criteria and did not receive smoking cessation counseling to serve as the control arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presents to Dartmouth-Hitchcock Medical Center in Lebanon, NH as an ambulatory patient with a scheduled cardiac Catheterization
- smoke one or more cigarettes per day for the past 12 months OR use of electronic-cigarettes containing tobacco at least once during the past 30 days.
- proficient in English
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Smoking Cessation CounselingSmoking cessation counseling will be provided following standards set by the institution patients are receiving care at (Dartmouth-Hitchcock Medical Center). | Behavioural | Smoking Cessation Counseling - Intervention Arm |
Primary outcome
Percentage of participants that self-report sustained smoking cessation
Time frame: 1 month post index procedure
Percentage of participants that self report sustained smoking cessation at 1 month.
Percentage of participants that self-report sustained smoking cessation
Time frame: 3 months post index procedure
Percentage of participants that self report sustained smoking cessation at 3 months.
Percentage of participants that self-report sustained smoking cessation
Time frame: 6 months post index procedure
Percentage of participants that self report sustained smoking cessation at 6 months.
12 secondary outcomes
Percentage of participants that have had at least one subsequent cardiovascular hospital admission.
Time frame: 1 month post index procedure
Percentage of participants that have had at least one subsequent cardiovascular hospital admission.
Time frame: 3 months post index procedure
Percentage of participants that have had at least one subsequent cardiovascular hospital admission.
Time frame: 6 months post index procedure
Percentage of participants that have had at least one emergency department presentation
Time frame: 1 month post index procedure
Percentage of participants that have had at least one emergency department presentation
Time frame: 3 months post index procedure
Percentage of participants that have had at least one emergency department presentation
Time frame: 6 months post index procedure
Frequency of Cardiac Events following discharge from index procedure
Time frame: 1 month post index procedure
Frequency of Cardiac Events following discharge from index procedure
Time frame: 3 months post index procedure
Frequency of Cardiac Events following discharge from index procedure
Time frame: 6 months post index procedure
Percentage of participants that need subsequent coronary intervention following index procedure
Time frame: 1 month post index procedure
Percentage of participants that need subsequent coronary intervention following index procedure
Time frame: 3 moths post index procedure
Percentage of participants that need subsequent coronary intervention following index procedure
Time frame: 6 months post index procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Individual participant dataSharing planned: No. No Plant to share individual participant data (IPD) exists at this time.
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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.
Merle L Myerson principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking Cessation Counseling in people with Smoking Cessation, run by Dartmouth-Hitchcock Medical Center 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 3 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: withdrawn, as of the sponsor's last update on 16 Feb 2023. 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 was withdrawn before enrolling participants, so there are no results.
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?
Percentage of participants that self-report sustained smoking cessation (time frame: 1 month post index procedure). The study lists 3 primary outcomes in all. 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 16 Feb 2023; AzTrials last refreshed its copy on 5 Nov 2026.