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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01072422
Other study ID # EPN 2008/1929-31/5
Secondary ID HSN 0803-0374
Status Completed
Phase N/A
First received
Last updated
Start date March 2010
Est. completion date September 2013

Study information

Verified date September 2020
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date September 2013
Est. primary completion date April 2013
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
smoking cessation
Use of trying to quit smoking instrument and quit smoking advice

Locations

Country Name City State
Sweden 200 primary health care centers across Stockholm County Stockholm

Sponsors (2)

Lead Sponsor Collaborator
Karolinska Institutet Stockholm County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Smoking cessation 3 months after patients' first visit to primary health care center
Secondary Validity of protocol Immediately after patients fill in protocol (baseline and 3 months after first visit to primary health care center)
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