NCT04313738

Brief Summary

Background: The aim of this study is to evaluate the efficiency of nursing intervention based on smoking cessation transtheoretical model in patients with COPD who smoke Method: Experimental design was used in the study. Thirty-three patients in the study group were completed with 35 chronic obstructive pulmonary disease patients in the control group. Sociodemographic characteristics data form, Fagerstrom Nicotine Dependency Test, Transteoretic Model Decision Making Scale, Self-efficacy Scale, Change Stages Scale and Behavior Modification Scale were used as data collection form. In the analysis of the data, the significance test of the difference between the two means, the significance test of the difference between two peers, the two-ratio test, Chi square, Mann Withney U test and Wilcoxon test were used. Results: Decision-making subscale scores, self-efficacy score scores, and behavior modification methods subscale scores showed significant increases (p\<.05) in the decision-making subscale of the patients in the experimental group after the home nursing interventions (p\<.05). While there was a significant improvement in the change stages, 9 patients in the experimental group and 2 patients in the control group had left the cigarette but the difference between them was significant (p\<.05). What does this paper contribute?

  • Nursing interventions with home visits based on transtheoretical model supplied to quit smoking of patients
  • The nursing interventions with home visits based on transtheoretical model contributed positively to behavioral change in patients' smoking cessation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2018

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 18, 2020

Completed
Last Updated

September 7, 2023

Status Verified

September 1, 2023

Enrollment Period

1.6 years

First QC Date

March 17, 2020

Last Update Submit

September 6, 2023

Conditions

Keywords

COPDSmoking cessationTranstheoretical modelHome visitNursingMotivational interview

Outcome Measures

Primary Outcomes (5)

  • Fagerström Test for Nicotine Dependence

    The test developed by Fagerström, Heatherton and Kozlowski in 1992 includes 6 items each of which is rated on a different scale. A total score ranging from 0 to 4 indicates low nicotine dependence, from 5 to 6 indicates moderate dependence and from 7 to 10 indicates high independence. It was adapted by Uysal et al. (2004). Cronbach's alpha value was 0.79 in the present study.

    6 mounth

  • Stages of Change (SOC) scale

    Prochaska and Diclemente (1983) explained smoking cessation through the gradual change process and developed the questions of change. Accordingly, people select one of the following corresponding to his/her situation: Precontemplation: I do not consider quitting smoking in the next six months. Contemplation: I am planning to quit smoking in the next six months. Preparation: I am planning to quit in the next 30 days. Action: I quit smoking less than six months ago. Maintenance: I have not been smoking for more than six months.

    6 mounth

  • Processes of Change (POC) scale

    The scale developed by Prochaska et al. (1988) includes 30 items questioning the cognitive processes (15 items) and behavioral processes (15 items). Each process contains five sub-dimensions. It is a five-point Likert type scale. The options determine which methods an individual uses in behavior change. In the present study, Cronbach's Alpha values ranged between 0.61 and 0.92.

    6 mounth

  • Self-Efficacy (SE) scale

    The scale developed by Velicer et al. (1990) measures the degree of confidence an individual has in maintaining non-smoking behavior in situations triggering smoking. It was adapted by Koyun, Bodur and Eroğlu (2015). Cronbach's alpha values of was 0.93 in the present study. The scale consists of eight items rated on a 5-point Likert type scale. The lowest and highest possible scores to be obtained from the scale are 8 and 40 respectively. The higher the score is the more successful the person is.

    6 mounth

  • Decisional Balance (DB) scale

    The scale developed by Velicer et al. (1985) has 12 items in two sub-dimensions: Pros of change (6 items) and Cons of change (6 items). The Cronbach's Alpha value was 0.71 and 0.85 in the present study. The items of the scale are rated on a five-point likert type scale. The minimum and maximum possible scores to be obtained from the scale are 6 and 30 respectively.

    6 mounth

Study Arms (2)

Intervention group

EXPERIMENTAL

Experimental: Intervention group Intervention group: Home visit, health education, telephone counseling At the intervention group; the researcher firstly made spirometry meausurement in hospital. After, the researcher made pretest (baseline measurement) before nursing interventions at the first home visit. At the first home visit, the researcher was offered education and guide smoking cessation. Second, Third and fourth home visit were made 15 days later, one and six months after visit first visit. During the second, third and fourth home visits, firstly the patient's stage of change was determined and then appropriate nursing intervention was performed in accordance with the guidelines.Between the third and fourth home visits, the participants were contacted through telephone calls once a month. At fourth home visit, the researcher made posttest. After the patient was invited to the hospital and spirometry measurements were repeated.

Other: Assigned Interventions

Control Group

NO INTERVENTION

At the control group; No home visits were paid to the control group. The researcher made measurements twice at in the first and sixth months in the hospital. The researcher also given at the end of the sixth month, all of the nursing interventions, given to the intervention group, for the control group.

Interventions

Home visit, health education

Intervention group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteering to participate in the study
  • Being diagnosed with COPD
  • Being \>40 years old
  • Being a smoker currently
  • Not having a physical or mental problem preventing the person from filling in the questionnaires to be used in the study and from using telephone
  • Using a mobile phone that is available at all times
  • Living in the city center of Samsun, a city on the north coast of Turkey
  • Not receiving any smoking cessation treatment at the time of the study
  • Not having medical contraindication preventing spirometric evaluation

You may not qualify if:

  • Patients with exacerbations in the last two months
  • Having receiving smoking cessation treatment
  • Not completing the home visits process
  • Agreeing to participate in the study but then withdrawing from the study for any reason
  • Being diagnosed with lung cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveSmoking Cessation

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHealth BehaviorBehavior

Study Officials

  • Figen Cavusoglu, Asst. Prof

    Ondokuz Mayıs University

    PRINCIPAL INVESTIGATOR
  • Ayse Beser, Prof

    Koç University

    STUDY DIRECTOR
  • Oguz Kılınc, Prof

    Dokuz Eylul University

    STUDY CHAIR
  • Nazmiye Tibel Tuna, Asst Prof

    Ondokuz Mayıs University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The study had a single-blind, randomized controlled experimental design. To avoid bias, participants were not told whether they were in the experimental or the control group
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized controlled experimental design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 17, 2020

First Posted

March 18, 2020

Study Start

April 1, 2016

Primary Completion

November 15, 2017

Study Completion

February 18, 2018

Last Updated

September 7, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share