NCT05029557

Brief Summary

Individuals who have COPD need a nursing service, which provides qualified and effective professional care, self-care, and supportive care to perform their daily life activities, and improve their quality of life. It is predicted that the Chronic Care-Based Training Program to be implemented and the follow-ups can increase the level of self-efficacy and satisfaction, and raise awareness on the management of the disease in patients. The purpose of the study was to evaluate the effects of the Chronic Care Model based education and telephone follow-up given to patients with COPD on self-efficacy and patient-reported outcomes. Also, the Modified Patient-Reported Outcome Scale for Chronic Obstructive Pulmonary Disease-mCOPD-PRO scale, which will be used in the study, will be adapted into Turkish language and culture, and will be used in the study after its validity and reliability are examined.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 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

August 26, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 31, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

December 27, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2022

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

7 months

First QC Date

August 26, 2021

Last Update Submit

February 26, 2024

Conditions

Keywords

Chronic Care Model

Outcome Measures

Primary Outcomes (4)

  • Evaluation of self-efficacy status

    The COPD Self-Efficacy Scale consists of 34 items and 5 subscales, and is used to determine the degree of confidence of COPD patients in managing or avoiding breathing difficulties in certain activities. The sub-factors of the scale consist of negative impact, emotional state, physical effort, weather/environment effect, and behavioral risk factors. On the scale, as the mean score increases, the degree of confidence also increases in managing or avoiding respiratory distress.

    0 months

  • Evaluation of self-efficacy status

    The COPD Self-Efficacy Scale consists of 34 items and 5 subscales, and is used to determine the degree of confidence of COPD patients in managing or avoiding breathing difficulties in certain activities. The sub-factors of the scale consist of negative impact, emotional state, physical effort, weather/environment effect, and behavioral risk factors. On the scale, as the mean score increases, the degree of confidence also increases in managing or avoiding respiratory distress.

    3 months

  • Evaluation of patient-reported results

    Modified Patient-Reported Outcome Scale for Chronic Obstructive Pulmonary Disease-mCOPD-PRO; The Turkish version of the scale will be used in the research after being adapted to the Turkish language and culture and examining its validity and reliability by the researcher. The scale consists of 27 items and physiological (17 items), psychological (7 items), and environmental (3 items) fields. The mCOPD-PRO is not a mere measurement of symptoms, it is a comprehensive measurement of disease-specific health status including physiological, psychological, and environmental domains. Each item consists of a 5-point Likert-type design, and the scores of the scale are graded between 0-4.

    0 months

  • Evaluation of patient-reported results

    Modified Patient-Reported Outcome Scale for Chronic Obstructive Pulmonary Disease-mCOPD-PRO; The Turkish version of the scale will be used in the research after being adapted to the Turkish language and culture and examining its validity and reliability by the researcher. The scale consists of 27 items and physiological (17 items), psychological (7 items), and environmental (3 items) fields. The mCOPD-PRO is not a mere measurement of symptoms, it is a comprehensive measurement of disease-specific health status including physiological, psychological, and environmental domains. Each item consists of a 5-point Likert-type design, and the scores of the scale are graded between 0-4.

    3 months

Secondary Outcomes (1)

  • The Patient Assessment of Chronic Illness Care

    3 months

Study Arms (2)

Control group patients

NO INTERVENTION

The patients in the Control Group will continue their routine procedures.

Education and telephone follow ups based on the Chronic Care Model

EXPERIMENTAL

Intervention Group will be given training (0 months) with the training booklet, which is prepared by the researcher based on the Chronic Care Model, and which includes information and suggestions about self-management strategies. The training will be organized in one single session in a way not to exceed approximately 45-50 minutes. The patients, who will be included in the Intervention Group, will be followed up by phone every two weeks. Also, reminders and informative information based on the training booklet will be sent to patients every week in the form of a short message.

Behavioral: Education and telephone follow ups based on the Chronic Care Model

Interventions

The effects of Chronic Care Model-based education and telephone follow-up given to patients with COPD on self-efficacy and patient-reported outcomes.

Education and telephone follow ups based on the Chronic Care Model

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years and older,
  • Confirmed COPD diagnosis
  • Ability to communicate and literate
  • Able to communicate by phone
  • Volunteering to participate in the research.

You may not qualify if:

  • Being closed to communication
  • Unable to communicate by phone
  • Not being a volunteer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, 27000, Turkey (Türkiye)

Location

Related Publications (1)

  • Sazak Y, Olgun N. The effect of Chronic Care Model-based follow-up on self-efficacy and patient-reported outcomes in COPD patients: a randomized controlled study. BMC Nurs. 2025 May 22;24(1):578. doi: 10.1186/s12912-025-03247-x.

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveLung Diseases, Obstructive

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Nermin OLGUN, Professor

    Hasan Kalyoncu University Faculty of Nursing

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 26, 2021

First Posted

August 31, 2021

Study Start

December 27, 2021

Primary Completion

July 10, 2022

Study Completion

July 10, 2022

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations