NCT06783582

Brief Summary

To determine the effect of motivational interviewing based on Pender's health promotion model on patient-reported outcomes in patients with COPD.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

March 29, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 20, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

January 22, 2025

Status Verified

January 1, 2025

Enrollment Period

11 months

First QC Date

January 15, 2025

Last Update Submit

January 20, 2025

Conditions

Keywords

Patient-reported OutcomesNurseCOPDMotivational InterviewingPender's Health Promotion Model

Outcome Measures

Primary Outcomes (3)

  • Adapted Patient Reported Outcome Scale for Chronic Obstructive Pulmonary Disease

    The Turkish validity and reliability study of the scale developed by Liu et al. in 2020 was conducted by Sazak and Orgun in 2023. The scale consists of 27 items in three dimensions. The dimensions are physical domain, environmental domain and psychological domain. The scale is a 5-point Likert type (Never 0, Almost never 1, A few times 2, Many times 3, Almost always 4). Item 13 should be reverse scored. Cronbach's Alpha reliability coefficient of the scale was determined as 0.954 for the overall scale, 0.945 for the physical domain sub-dimension, 0.862 for the psychological domain sub-dimension and 0.828 for the environmental sub-dimension.

    Up to 4 weeks

  • Modified Medical Research Council (mMRC) Dyspnea Scale

    The dyspnea scale, developed by Fletcher in 1952, was used to compare the dyspnea levels of individuals with lung disease and those without during activity. Later, the scale was developed by the British Medical Research Council (MRC) to evaluate the course of diseases. The scale, which is based on various physical activities to determine dyspnea, consists of 5 items and is scored between 0 and 4 points. The best point in terms of dyspnea on the scale is 0, while the worst is defined as 4 points.

    Up to 4 weeks

  • COPD Assessment Test (CAT)

    Developed by Jones et al. in 2009, the scale was validated in Turkish by Yorgancıoğlu et al. in 2012. CAT determines disease severity by evaluating symptoms such as cough, phlegm, shortness of breath, fatigue, and leaving home. The scores of the questions in the test range from "0-40". CAT assessment test score; 0-10 is considered "low impact", 11-20 is considered "moderate impact", 21-30 is considered "high impact", and 31-40 is considered "very high impact".

    Up to 4 weeks

Study Arms (2)

Motivational Interviewing

EXPERIMENTAL

The intervention group will given 30-45 minutes of motivational interviewing.

Other: Motivational interviewing based on Pender's health promotion model

Control Group

NO INTERVENTION

Routine nursing care was given to COPD patients in this group without any interview.

Interventions

In addition to routine nursing care, patients will be given a motivational interview intervention based on Pender's health promotion model. This intervention will be carried out in a total of 6 sessions, three face-to-face sessions and three online sessions planned individually for each patient. The interviews will last approximately 30-45 minutes. The first motivational interview will be held on the 1st day of the patient's admission to the clinic, the second motivational interview on the 4th day, and the third motivational interview on the 7th day. The face-to-face sessions will be conducted by the researcher in the hospital's education room and contact information will be obtained from the patients. The following three interviews will be held online with the patients once a week via the WhatsApp application. The patient will be contacted at least two days before the interviews, an appointment will be made, and the interview day and time will be determined.

Motivational Interviewing

Eligibility Criteria

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

You may qualify if:

  • Being over 18 years of age,
  • Volunteering to participate in the study,
  • Being literate,
  • Having GOLD Stage II and III COPD,
  • Receiving COPD treatment for more than 6 months,
  • Having a smartphone for online interviews,
  • Not having sensory loss related to hearing and vision,
  • Not having a history of psychiatric diagnosis,
  • Being suitable for applying cognitive level scales.

You may not qualify if:

  • Having GOLD Stage I and IV COPD,
  • Having serious pulmonary and malignant disease,
  • Not being able to communicate in Turkish,
  • Being in an exacerbation period,
  • Having a history of psychiatric diagnosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University

Erzurum, 25700, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

January 15, 2025

First Posted

January 20, 2025

Study Start

March 29, 2024

Primary Completion

February 24, 2025

Study Completion

March 30, 2025

Last Updated

January 22, 2025

Record last verified: 2025-01

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