SmokingNCT01072422
Smoking Cessation in Primary Health Care Patients With Obstructive Pulmonary Disease
A study testing smoking cessation in people with Smoking and Pulmonary Disease, Chronic Obstructive, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of this study is to determine if an assessment protocol that measures the need for support with smoking cessation and that will be administered by primary health care nurses helps patients with obstructive pulmonary disease (COPD) quit smoking. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Smoking, Pulmonary Disease, Chronic Obstructive
- What is being tested?
- smoking cessation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2010to Sep 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Physician diagnosis of COPD
- Current smoker
- Speak Swedish well enough to answer the TTQ assessment protocol
Who cannot join
- Cognitive difficulties that, in the judgment of the participating nurses, would make it difficult for the patient to answer the TTQ assessment protocol or benefit from counseling
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine if an assessment protocol that measures the need for support with smoking cessation and that will be administered by primary health care nurses helps patients with obstructive pulmonary disease (COPD) quit smoking.
Read the detailed description
Some patients with COPD continue to smoke despite the importance of quitting. A specially developed assessment protocol for such patients may support nurses in their discussions with the patients about smoking cessation. In a previous qualitative study involving in-depth interviews with patients with COPD, the assessment protocol "Trying to quit smoking" (TTQ) was developed. The protocol consists of approximately 21 statements that the patient responds to on a scale ranging from 1 (agree entirely) to 4 (disagree). The purpose of the protocol is to identify areas in which the patient may need extra support in order to quit smoking.
The aim of this study is to validate the TTQ by testing it in a clinical setting. The study will be conducted at approximately 40 primary health care centers in Stockholm County. The nurses will identify 5 consecutive patients who have COPD and smoke. All nurses will complete a questionnaire for each patient at baseline (after visit 1) and after 3 months describing treatment provided. The nurses will ask each patient to fill in the TTQ and will provide individual counseling on the basis of the answers. After 3 months, the nurses will ask all patients if they still smoke and to fill in the TTQ again. Appropriate statistical methods will be used to analyze the questionnaire data.
- Conditions
- Smoking, Pulmonary Disease, Chronic Obstructive
- Being tested
- smoking cessation
- Keywords
- Smoking, Pulmonary Disease, Chronic Obstructive, Questionnaires, Nurses, Primary Health Care
- Medical subject headings
- Smoking, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smoking cessationBehavioural
Use of trying to quit smoking instrument and quit smoking advice
| Study group | Role | What they receive |
|---|---|---|
| counseling based on answers in TTQ | Experimental | 40 participating primary health care nurses will be randomly assigned to this arm. Each nurse will identify 5 consecutive patients with COPD who smoke (n = 200 total patients). The nurses will ask the patients to fill in the assessment protocol, TTQ. The nurses will then provide an intervention to each patient in the form of individual treatment on the basis of that patient's answers to the TTQ. Receives: Behavioral: smoking cessation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking cessation
Measured: 3 months after patients' first visit to primary health care center
Secondary outcomes (1)
Validity of protocol
Measured: Immediately after patients fill in protocol (baseline and 3 months after first visit to primary health care center)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionApr 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Lena Lundh, Karolinska Institutet
- Investigators
- Lena Lundh, MSc nursing, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01072422
- Sponsor's protocol ID
- EPN 2008/1929-31/5
- Other IDs
- HSN 0803-0374
- Status last verified
- Sep 2020
- First submitted
- 19 Feb 2010
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Cessation in Primary Health Care Patients With Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01072422
- Acronym / sponsor ID
- EPN 2008/1929-31/5
- Conditions
- Smoking, Pulmonary Disease, Chronic Obstructive
- Keywords
- Smoking, Pulmonary Disease, Chronic Obstructive, Questionnaires, Nurses, Primary Health Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- Mar 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 22 Feb 2010 (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 purpose of this study is to determine if an assessment protocol that measures the need for support with smoking cessation and that will be administered by primary health care nurses helps patients with obstructive pulmonary disease (COPD) quit smoking.
Detailed description
Some patients with COPD continue to smoke despite the importance of quitting. A specially developed assessment protocol for such patients may support nurses in their discussions with the patients about smoking cessation. In a previous qualitative study involving in-depth interviews with patients with COPD, the assessment protocol "Trying to quit smoking" (TTQ) was developed. The protocol consists of approximately 21 statements that the patient responds to on a scale ranging from 1 (agree entirely) to 4 (disagree). The purpose of the protocol is to identify areas in which the patient may need extra support in order to quit smoking.
The aim of this study is to validate the TTQ by testing it in a clinical setting. The study will be conducted at approximately 40 primary health care centers in Stockholm County. The nurses will identify 5 consecutive patients who have COPD and smoke. All nurses will complete a questionnaire for each patient at baseline (after visit 1) and after 3 months describing treatment provided. The nurses will ask each patient to fill in the TTQ and will provide individual counseling on the basis of the answers. After 3 months, the nurses will ask all patients if they still smoke and to fill in the TTQ again. Appropriate statistical methods will be used to analyze the questionnaire data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| counseling based on answers in TTQ | Experimental | Behavioral: smoking cessation40 participating primary health care nurses will be randomly assigned to this arm. Each nurse will identify 5 consecutive patients with COPD who smoke (n = 200 total patients). The nurses will ask the patients to fill in the assessment protocol, TTQ. The nurses will then provide an intervention to each patient in the form of individual treatment on the basis of that patient's answers to the TTQ. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Physician diagnosis of COPD
- Current smoker
- Speak Swedish well enough to answer the TTQ assessment protocol
Key exclusion criteria (1 listed)
- Cognitive difficulties that, in the judgment of the participating nurses, would make it difficult for the patient to answer the TTQ assessment protocol or benefit from counseling
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 cessationUse of trying to quit smoking instrument and quit smoking advice | Behavioural | counseling based on answers in TTQ |
Primary outcome
Smoking cessation
Time frame: 3 months after patients' first visit to primary health care center
1 secondary outcome
Validity of protocol
Time frame: Immediately after patients fill in protocol (baseline and 3 months after first visit to primary health care center)
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 14 Sep 2020.
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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.
Lena Lundh, MSc nursing principal investigator
Karolinska Institutet
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 in people with Smoking and Pulmonary Disease, Chronic Obstructive, run by Karolinska Institutet at 1 site in Sweden.
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: finished, as of the sponsor's last update on 14 Sep 2020. 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 Sweden. 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.
What does the primary outcome measure?
Smoking cessation (time frame: 3 months after patients' first visit to primary health care center). 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 14 Sep 2020.