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).
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
- Recruiting
Ataturk University
Erzurum, 25700
Zeynep YILDIRIM, Principal Investigator, +905365978465, zeynepyildirim@atauni.edu.tr
Mağfiret KAŞIKÇI, Prof. Dr., 05327839114, magfiret@atauni.edu.tr
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.
- Conditions
- COPD, Nurse-Patient Relations
- 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 group | Role | What they receive |
|---|---|---|
| Motivational Interviewing | Experimental | The intervention group will given 30-45 minutes of motivational interviewing. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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.
- First posted20 Jan 2025
- Study start29 Mar 2024
- Primary completion24 Feb 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Zeynep Yildirim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zeynep Yildirim, Ataturk University
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Motivational Interviewing Based on Pender's Health Promotion Model on Patient-Reported Outcomes in Patients With COPD
- ClinicalTrials.gov ID
- NCT06783582
- Acronym / sponsor ID
- Thesis
- Conditions
- COPD, Nurse-Patient Relations
- Keywords
- Patient-reported Outcomes, Nurse, COPD, Motivational Interviewing, Pender's Health Promotion Model
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Zeynep YildirimUniversity, hospital or other
- Study start
- 29 Mar 2024 (actual)
- Primary completion
- 24 Feb 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the effect of motivational interviewing based on Pender's health promotion model on patient-reported outcomes in patients with COPD.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing | Experimental | Other: Motivational interviewing based on Pender's health promotion modelThe intervention group will given 30-45 minutes of motivational interviewing. |
| Control Group | No intervention | –Routine nursing care was given to COPD patients in this group without any interview. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational interviewing based on Pender's health promotion modelIn 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. | Other | Motivational Interviewing |
Primary outcome
Adapted Patient Reported Outcome Scale for Chronic Obstructive Pulmonary Disease
Time frame: Up to 4 weeks
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.
Modified Medical Research Council (mMRC) Dyspnea Scale
Time frame: Up to 4 weeks
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.
COPD Assessment Test (CAT)
Time frame: Up to 4 weeks
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".
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
Related trials for COPD
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.