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Smoking Cessation in Primary Health Care Patients With Obstructive Pulmonary Disease

Primary Purpose

Smoking, Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
smoking cessation
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking focused on measuring Smoking, Pulmonary Disease, Chronic Obstructive, Questionnaires, Nurses, Primary Health Care

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 200 primary health care centers across Stockholm County

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

counseling based on answers in TTQ

Arm Description

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.

Outcomes

Primary Outcome Measures

Smoking cessation

Secondary Outcome Measures

Validity of protocol

Full Information

First Posted
February 19, 2010
Last Updated
September 10, 2020
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
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1. Study Identification

Unique Protocol Identification Number
NCT01072422
Brief Title
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

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Region Stockholm

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Pulmonary Disease, Chronic Obstructive
Keywords
Smoking, Pulmonary Disease, Chronic Obstructive, Questionnaires, Nurses, Primary Health Care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
counseling based on answers in TTQ
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
smoking cessation
Intervention Description
Use of trying to quit smoking instrument and quit smoking advice
Primary Outcome Measure Information:
Title
Smoking cessation
Time Frame
3 months after patients' first visit to primary health care center
Secondary Outcome Measure Information:
Title
Validity of protocol
Time Frame
Immediately after patients fill in protocol (baseline and 3 months after first visit to primary health care center)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lena Lundh, MSc nursing
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
200 primary health care centers across Stockholm County
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

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Smoking Cessation in Primary Health Care Patients With Obstructive Pulmonary Disease

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