Clinical trial NCT01072422: Smoking Cessation in Primary Health Care Patients With Obstructive Pulmonary Disease
Official title: Smoking Cessation in Primary Health Care Patients With Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Pulmonary Disease, Chronic Obstructive
Keywords: Smoking
Pulmonary Disease, Chronic Obstructive
Questionnaires
Nurses
Primary Health Care
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2010-02-22
Enrollment: 110
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Physician diagnosis of COPD
* Current smoker
* Speak Swedish well enough to answer the TTQ assessment protocol

Exclusion Criteria:

* 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

Primary outcomes:
measure: Smoking cessation
timeFrame: 3 months after patients' first visit to primary health care center
Secondary outcomes:
measure: Validity of protocol
timeFrame: Immediately after patients fill in protocol (baseline and 3 months after first visit to primary health care center)
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: 200 primary health care centers across Stockholm County
Study officials:
affiliation: Karolinska Institutet
name: Lena Lundh, MSc nursing
role: PRINCIPAL_INVESTIGATOR
References: