Smoking Cessation in Primary Health Care Patients With Obstructive Pulmonary Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Karolinska Institutet.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Stockholm County Council, Sweden
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01072422
First received: February 19, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Smoking cessation [ Time Frame: 3 months after patients' first visit to primary health care center ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01072422

Contacts
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

Locations
Sweden
200 primary health care centers across Stockholm County Not yet recruiting
Stockholm, Sweden
Principal Investigator: Lena Lundh, MSc nursing         
Sponsors and Collaborators
Karolinska Institutet
Stockholm County Council, Sweden
Investigators
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:
Lung Diseases
Lung Diseases, Obstructive
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 30, 2014