Smoking Cessation in Primary Health Care Patients With Obstructive Pulmonary Disease
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|ClinicalTrials.gov Identifier: NCT01072422|
Recruitment Status : Unknown
Verified February 2010 by Karolinska Institutet.
Recruitment status was: Not yet recruiting
First Posted : February 22, 2010
Last Update Posted : February 22, 2010
|Condition or disease||Intervention/treatment||Phase|
|Smoking Pulmonary Disease, Chronic Obstructive||Behavioral: Counseling based on answers to the assessment protocol||Not Applicable|
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 40 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. Nurses at the participating centers will be randomized into a group that will give patients care as usual (Usual care group) and a group that will administer the protocol to patients (Protocol group). The nurses in both groups will identify 10 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 in the Protocol group 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 in both groups will ask all patients if they still smoke. The nurses in the Protocol group will ask the patients to fill in the TTQ again. Appropriate statistical methods will be used to analyze the questionnaire data.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Smoking Cessation in Primary Health Care Patients With Obstructive Pulmonary Disease|
|Study Start Date :||March 2010|
|Estimated Primary Completion Date :||February 2011|
|Estimated Study Completion Date :||May 2011|
No Intervention: Usual care
20 of the 40 participating primary health care nurses will be randomly assigned to this group. They will identify 10 consecutive patients with COPD who smoke (n = 200 patients in total). The nurses will provide these patients with care as usual.
Experimental: Protocol arm
20 of the 40 participating primary health care nurses will be randomly assigned to this arm. Each nurse will identify 10 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.
Behavioral: Counseling based on answers to the assessment protocol
Each patient in the Protocol arm will fill in a TTQ at baseline. On the basis of the patients' answers, the nurse will provide individual counseling aimed at helping this patient overcome obstacles to smoking cessation.
- Smoking cessation [ Time Frame: 3 months after patients' first visit to primary health care center ]
- Validity of protocol [ Time Frame: Immediately after patients fill in protocol (baseline and 3 months after first visit to primary health care center) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01072422
|Contact: Lena Lundh, MSc nursing||+46 8 524 88 firstname.lastname@example.org|
|Contact: Lena Tornkvist, PhD||+46 8 524 88 email@example.com|
|200 primary health care centers across Stockholm County||Not yet recruiting|
|Principal Investigator: Lena Lundh, MSc nursing|
|Principal Investigator:||Lena Lundh, MSc nursing||Karolinska Institutet|