Smoking Cessation in Primary Health Care Patients With Obstructive Pulmonary Disease
Recruitment status was Not yet recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Smoking Pulmonary Disease, Chronic Obstructive |
Behavioral: Counseling based on answers to the assessment protocol |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Smoking Cessation in Primary Health Care Patients With Obstructive Pulmonary Disease |
- Smoking cessation [ Time Frame: 3 months after patients' first visit to primary health care center ] [ Designated as safety issue: No ]
- Validity of protocol [ Time Frame: Immediately after patients fill in protocol (baseline and 3 months after first visit to primary health care center) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 400 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | May 2011 |
| Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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 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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Lena Lundh, MSc nursing | +46 8 524 88 752 | lena.k.lund@sll.se |
| Contact: Lena Tornkvist, PhD | +46 8 524 88 756 | lena.tornkvist@sll.se |
| Sweden | |
| 200 primary health care centers across Stockholm County | Not yet recruiting |
| Stockholm, Sweden | |
| Principal Investigator: Lena Lundh, MSc nursing | |
| Principal Investigator: | Lena Lundh, MSc nursing | Karolinska Institutet |
More Information
No publications provided
| Responsible Party: | Lena Lundh, Karolinska Institutet |
| ClinicalTrials.gov Identifier: | NCT01072422 History of Changes |
| Other Study ID Numbers: | EPN 2008/1929-31/5, HSN 0803-0374 |
| Study First Received: | February 19, 2010 |
| Last Updated: | February 19, 2010 |
| Health Authority: | Sweden: Regional Ethical Review Board |
Keywords provided by Karolinska Institutet:
|
Smoking Pulmonary Disease, Chronic Obstructive Questionnaires Nurses Primary Health Care |
Additional relevant MeSH terms:
|
Chronic Disease Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Smoking |
Lung Diseases, Obstructive Disease Attributes Pathologic Processes Respiratory Tract Diseases Habits |
ClinicalTrials.gov processed this record on June 17, 2013