NCT01072422

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 22, 2010

Completed
7 days until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

September 14, 2020

Status Verified

September 1, 2020

Enrollment Period

3.1 years

First QC Date

February 19, 2010

Last Update Submit

September 10, 2020

Conditions

Keywords

SmokingPulmonary Disease, Chronic ObstructiveQuestionnairesNursesPrimary Health Care

Outcome Measures

Primary Outcomes (1)

  • Smoking cessation

    3 months after patients' first visit to primary health care center

Secondary Outcomes (1)

  • Validity of protocol

    Immediately after patients fill in protocol (baseline and 3 months after first visit to primary health care center)

Study Arms (1)

counseling based on answers in TTQ

EXPERIMENTAL

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.

Behavioral: smoking cessation

Interventions

Use of trying to quit smoking instrument and quit smoking advice

counseling based on answers in TTQ

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Physician diagnosis of COPD
  • Current smoker
  • Speak Swedish well enough to answer the TTQ assessment protocol

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

200 primary health care centers across Stockholm County

Stockholm, Sweden

Location

MeSH Terms

Conditions

SmokingPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

BehaviorLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lena Lundh, MSc nursing

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN MScN

Study Record Dates

First Submitted

February 19, 2010

First Posted

February 22, 2010

Study Start

March 1, 2010

Primary Completion

April 1, 2013

Study Completion

September 1, 2013

Last Updated

September 14, 2020

Record last verified: 2020-09

Locations