Smoking Cessation in Primary Health Care Patients With Obstructive Pulmonary Disease

NCT ID: NCT01072422

Last Updated: 2020-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2013-09-30

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.

Conditions

Smoking; Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

counseling based on answers in TTQ

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.

Group Type: EXPERIMENTAL

smoking cessation

Intervention Type: BEHAVIORAL

Use of trying to quit smoking instrument and quit smoking advice

Interventions

smoking cessation

Use of trying to quit smoking instrument and quit smoking advice

Intervention Type: BEHAVIORAL

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Stockholm

OTHER_GOV

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Lena Lundh

RN MScN

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lena Lundh, MSc nursing

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

200 primary health care centers across Stockholm County

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

HSN 0803-0374

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

EPN 2008/1929-31/5

Identifier Type: -

Identifier Source: org_study_id