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COPDNCT06783582

Effectiveness of Motivational Interviewing in Patients With COPD

A study testing Motivational interviewing based on Pender's health promotion model in people with COPD and Nurse-Patient Relations, run by Zeynep Yildirim at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COPD, Nurse-Patient Relations
What is being tested?
Motivational interviewing based on Pender's health promotion model
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteTurkey (Türkiye)
Study dates
29 Mar 2024to 30 Mar 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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,
Show all 9Show fewer
  • Not having sensory loss related to hearing and vision,
  • Not having a history of psychiatric diagnosis,
  • Being suitable for applying cognitive level scales.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site, 1 recruiting
  • Ataturk University

    Erzurum, 25700

    Zeynep YILDIRIM, Principal Investigator, +905365978465, zeynepyildirim@atauni.edu.tr

    Mağfiret KAŞIKÇI, Prof. Dr., 05327839114, magfiret@atauni.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Effect of Motivational Interviewing Based on Pender's Health Promotion Model on Patient-Reported Outcomes in Patients With COPD

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

Read the detailed description

Nursing, which arises from human needs, evaluates the individual, family, and society with a holistic perspective to protect, maintain, and improve the health of healthy/sick individuals, families, and communities, and provides the necessary health services. The primary duty of nurses is to provide care for individuals and improve their quality of life. In this regard, nurses fulfill their duties by using their roles such as counselor, educator, decision-maker, manager, researcher, and caregiver. Nurses have significant responsibilities in the care of chronic diseases that require lifelong care and follow-up.

One of the major chronic diseases requiring lifelong care is Chronic Obstructive Pulmonary Disease (COPD). COPD is a progressive, irreversible disease characterized by airflow obstruction, accompanied by various symptoms, and is a serious health problem with high mortality and morbidity, commonly encountered worldwide. Approximately 3.2 million people die annually from COPD globally, and it is projected that this disease will be the third leading cause of death worldwide by 2030. COPD patients experience many physical and psychological issues that severely affect their quality of life, such as fear of death, anxiety, cough, dyspnea, fatigue, and loss of appetite . COPD patients are frequently hospitalized, face difficulties in performing daily activities, encounter social and economic losses, and experience a significant decline in quality of life due to the side effects of medications.

Among the long-term management goals of disease control are the reduction of current symptoms and future risks. These goals require patients to exhibit healthy behaviors. However, the literature reports that COPD patients have low levels of self-care, poor adherence to medications, and a lack of awareness regarding preventable and behavioral causal factors. COPD patients need strategies that will engage them in the treatment process, motivate them toward healthy habits, and help internalize healthy behaviors. Compared to other strategies, motivational interviewing (MI) embodies most of these qualities. MI is defined as "collaborative, person-centered form of guiding and counseling to elicit and strengthen motivation for change". The MI technique is a distinctive and superior approach to other interview methods due to its effectiveness in helping individuals make behavioral changes, its empathetic and collaborative approach, its ability to increase intrinsic motivation, and its strategies for dealing with resistance. MI aims to promote change by increasing the patients intrinsic motivation, making it especially effective for patients with more specific change goals.

The use of nursing models in the care of COPD patients has been associated with better patient outcomes, higher nurse satisfaction, and lower healthcare costs. Pender's Health Promotion Model (HPM) provides nurses with a comprehensive framework for conducting effective care and assessing individuals perceptions of health behaviors. The model assumes that individuals have a holistic structure in their physical environment and interpersonal relationships and play an active role in maintaining and promoting their health. The goal of the model is to explain the components of behaviors necessary for a healthy lifestyle, evaluate individuals experiences, analyze factors that may affect their perceptions of health behavior, and guide care providers in planning healthy lifestyle goals. In light of this information, it is recognized that MI and HPM share common goals and possess complementary dynamics. Addressing lifestyle changes with Pender\'s model and integrating MI for health promotion has been reported to be more effective in managing COPD patients symptoms. Dişsiz and Çalışkan also suggest that nurses can use HPM and MI, which are thought to complement each other, while helping patients acquire healthy lifestyle behaviors.

Patient-reported outcomes are necessary to assess the symptoms, the impact of symptoms on their lives, and their response to treatment. Patient-reported outcomes provide direct reports of patients perceived health statuses. While the primary role of nurses is caregiving, they should also engage in roles such as educator, therapist, counselor, and researcher to implement interventions that improve the care of COPD patients. Nurses should support individuals to use their potential strengths and help them adopt health behaviors through health promotion programs. MI and the Health Promotion Model have been shown to be effective strategies and models in facilitating health behavior change. Based on this information, this research was conducted to determine the effect of motivational interviewing based on Pender's Health Promotion Model on patient-reported outcomes in COPD patients.

Being tested
Motivational interviewing based on Pender's health promotion model
Keywords
Patient-reported Outcomes, Nurse, COPD, Motivational Interviewing, Pender's Health Promotion Model
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Motivational interviewing based on Pender's health promotion modelOther

    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.

Study groups in NCT06783582
Study groupRoleWhat they receive
Motivational InterviewingExperimentalThe intervention group will given 30-45 minutes of motivational interviewing.
Receives: Other: Motivational interviewing based on Pender's health promotion model
Control GroupNo interventionRoutine nursing care was given to COPD patients in this group without any interview.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 4 weeks

  2. 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.

    Measured: Up to 4 weeks

  3. 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".

    Measured: Up to 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2025
  2. Study start29 Mar 2024
  3. Primary completion24 Feb 2025 (estimated)
  4. Study completion30 Mar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06783582
Sponsor's protocol ID
Thesis
Status last verified
Jan 2025
First submitted
15 Jan 2025
Last updated
22 Jan 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Motivational interviewing based on Pender's health promotion model in people with COPD and Nurse-Patient Relations, run by Zeynep Yildirim at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adapted Patient Reported Outcome Scale for Chronic Obstructive Pulmonary Disease (time frame: Up to 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.

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