Pulmonary Disease, Chronic ObstructiveNCT05029557
The Effect of Education Based on the Chronic Care Model in COPD Patients
A study testing Education and telephone follow ups based on the Chronic Care Model in people with Pulmonary Disease, Chronic Obstructive and Lung Diseases, Obstructive, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive, Self-Management
- What is being tested?
- Education and telephone follow ups based on the Chronic Care Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Dec 2021to 10 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 18 years and older,
- Confirmed COPD diagnosis
- Ability to communicate and literate
- Able to communicate by phone
- Volunteering to participate in the research.
Who cannot join
- Being closed to communication
- Unable to communicate by phone
- Not being a volunteer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Education and Telephone Follow-up Based on the Chronic Care Model on Self-efficacy and Patient-reported Outcomes in COPD Patients
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.
Read the detailed description
Chronic Obstructive Pulmonary Disease is a major global healthcare problem with its high prevalence, increasing incidence (partly due to population aging), and major serious personal, social, and economic costs. Individuals who have COPD require a nursing service that provides qualified and effective professional care, self-care, and supportive care to perform their daily life activities and improve their quality of life. Nurses have active roles in the management of COPD as professional members of the team, and perform the roles of caregiving, consultancy, researcher, manager, and trainer in COPD management. The skills needed for the management of COPD and the knowledge and interventions to develop these skills are conceptualized as self-management, which is a complex structure including drug compliance, smoking cessation, maintaining and increasing exercise capacity, healthy lifestyle changes that include nutrition regulation, vaccination, and symptom management. The purpose of "Self-management" in COPD is stated in the GOLD 2021 report as "to provide motivation, encouragement, and guidance for patients to acquire positive health behaviors and to gain the ability to cope with their disease". The Self-Management Training and Guidance provided by healthcare staff must be the basic element of the "Chronic Diseases Care Model" in the scope of the healthcare provided. Although various models were proposed for chronic disease management, the best known, most used, and most effective among these is the Chronic Care Model. The model has the quality of being a roadmap for high-quality and patient-centered service delivery in chronic diseases. Four components of the Chronic Care Model will be implemented in the present study, which are; Decision Making Support, Self-Management Support, Health Services Delivery Plan, and Clinical Information Systems. The study has a randomized controlled experimental study design. The sampling of the study will consist of the patients who were diagnosed with COPD, hospitalized in Elbistan State Hospital Chest Policlinic of Kahramanmaraş Provincial Health Directorate, met the inclusion criteria, and who volunteer to participate in the study. A total of 66 patients, 33 in the Control Group, and 33 in the Intervention Group will be randomized into groups in the computer medium.
According to the intervention protocol of the study,
- A training booklet will be created for COPD patients in the scope of the Chronic Care Model self-management support component of the study. The quality of the booklet will be evaluated by submitting it to expert opinions.
- Patients who meet the inclusion criteria will be included in the present study as the Intervention and Control Group according to the randomization list.
- Patients in the Control and Intervention Group will be interviewed and their pre-test data will be collected after informed consent is obtained from them. For this purpose, Patient Information Form, COPD Self-Efficacy Scale, 6MWT, COPD Assessment Test (CAT),modified Medical Research Council (mMRC) Dyspnea Scale, Modified Patient-Reported Outcome Scale for Chronic Obstructive Pulmonary Disease (mCOPD-PRO) Scale will be used.
- After the pre-tests are completed, the patients in the 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.
- The patients in the Control Group will continue their routine procedures.
- Post-tests will be applied to the patients who will be included in the Control and Intervention Group at the 3rd-month polyclinic follow-up. The Patient Assessment of Chronic Illness Care (PACIC) will be used in this post-test in addition to the pre-tests. At the end of the study, Training will be given to the Control Group patients along with Training Booklet.
- Conditions
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive, Self-Management, Nursing Care
- Being tested
- Education and telephone follow ups based on the Chronic Care Model
- Keywords
- Chronic Care Model
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education and telephone follow ups based on the Chronic Care ModelBehavioural
The effects of Chronic Care Model-based education and telephone follow-up given to patients with COPD on self-efficacy and patient-reported outcomes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Education and telephone follow ups based on the Chronic Care Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Secondary outcomes (1)
The Patient Assessment of Chronic Illness Care
The Patient Assessment of Chronic Illness Care (PACIC) is a relatively brief 20-item questionnaire designed to assess the extent to which care is aligned with the Chronic Care Model. It consists five factors and, 20-item. The increase in the scale scores shows that individuals with chronic disease are highly satisfied with the care they receive.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start27 Dec 2021
- Primary completion10 Jul 2022
- Study completion10 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin SAZAK, Hasan Kalyoncu University
- Investigators
- Nermin OLGUN, Professor, Study director, Hasan Kalyoncu University Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05029557
- Sponsor's protocol ID
- HasanKU-SAZAK-001
- Status last verified
- Feb 2024
- First submitted
- 26 Aug 2021
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40405196
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education and Telephone Follow-up Based on the Chronic Care Model on Self-efficacy and Patient-reported Outcomes in COPD Patients
- ClinicalTrials.gov ID
- NCT05029557
- Acronym / sponsor ID
- HasanKU-SAZAK-001
- Conditions
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive, Self-Management, Nursing Care
- Keywords
- Chronic Care Model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 27 Dec 2021 (actual)
- Primary completion
- 10 Jul 2022 (actual)
- Study completion
- 10 Jul 2022 (actual)
- First posted
- 31 Aug 2021 (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.
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.
Detailed description
Chronic Obstructive Pulmonary Disease is a major global healthcare problem with its high prevalence, increasing incidence (partly due to population aging), and major serious personal, social, and economic costs. Individuals who have COPD require a nursing service that provides qualified and effective professional care, self-care, and supportive care to perform their daily life activities and improve their quality of life. Nurses have active roles in the management of COPD as professional members of the team, and perform the roles of caregiving, consultancy, researcher, manager, and trainer in COPD management. The skills needed for the management of COPD and the knowledge and interventions to develop these skills are conceptualized as self-management, which is a complex structure including drug compliance, smoking cessation, maintaining and increasing exercise capacity, healthy lifestyle changes that include nutrition regulation, vaccination, and symptom management. The purpose of "Self-management" in COPD is stated in the GOLD 2021 report as "to provide motivation, encouragement, and guidance for patients to acquire positive health behaviors and to gain the ability to cope with their disease". The Self-Management Training and Guidance provided by healthcare staff must be the basic element of the "Chronic Diseases Care Model" in the scope of the healthcare provided. Although various models were proposed for chronic disease management, the best known, most used, and most effective among these is the Chronic Care Model. The model has the quality of being a roadmap for high-quality and patient-centered service delivery in chronic diseases. Four components of the Chronic Care Model will be implemented in the present study, which are; Decision Making Support, Self-Management Support, Health Services Delivery Plan, and Clinical Information Systems. The study has a randomized controlled experimental study design. The sampling of the study will consist of the patients who were diagnosed with COPD, hospitalized in Elbistan State Hospital Chest Policlinic of Kahramanmaraş Provincial Health Directorate, met the inclusion criteria, and who volunteer to participate in the study. A total of 66 patients, 33 in the Control Group, and 33 in the Intervention Group will be randomized into groups in the computer medium.
According to the intervention protocol of the study,
- A training booklet will be created for COPD patients in the scope of the Chronic Care Model self-management support component of the study. The quality of the booklet will be evaluated by submitting it to expert opinions.
- Patients who meet the inclusion criteria will be included in the present study as the Intervention and Control Group according to the randomization list.
- Patients in the Control and Intervention Group will be interviewed and their pre-test data will be collected after informed consent is obtained from them. For this purpose, Patient Information Form, COPD Self-Efficacy Scale, 6MWT, COPD Assessment Test (CAT),modified Medical Research Council (mMRC) Dyspnea Scale, Modified Patient-Reported Outcome Scale for Chronic Obstructive Pulmonary Disease (mCOPD-PRO) Scale will be used.
- After the pre-tests are completed, the patients in the 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.
- The patients in the Control Group will continue their routine procedures.
- Post-tests will be applied to the patients who will be included in the Control and Intervention Group at the 3rd-month polyclinic follow-up. The Patient Assessment of Chronic Illness Care (PACIC) will be used in this post-test in addition to the pre-tests. At the end of the study, Training will be given to the Control Group patients along with Training Booklet.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Education and telephone follow ups based on the Chronic Care ModelIntervention 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years and older,
- Confirmed COPD diagnosis
- Ability to communicate and literate
- Able to communicate by phone
- Volunteering to participate in the research.
Key exclusion criteria (3 listed)
- Being closed to communication
- Unable to communicate by phone
- Not being a volunteer
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 |
|---|---|---|
| Education and telephone follow ups based on the Chronic Care ModelThe effects of Chronic Care Model-based education and telephone follow-up given to patients with COPD on self-efficacy and patient-reported outcomes. | Behavioural | Education and telephone follow ups based on the Chronic Care Model |
Primary outcome
Evaluation of self-efficacy status
Time frame: 0 months
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.
Evaluation of self-efficacy status
Time frame: 3 months
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.
Evaluation of patient-reported results
Time frame: 0 months
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.
Evaluation of patient-reported results
Time frame: 3 months
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.
1 secondary outcome
The Patient Assessment of Chronic Illness Care
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Derived from this study: PubMed 40405196Sazak 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Nermin OLGUN, Professor study director
Hasan Kalyoncu University Faculty of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and telephone follow ups based on the Chronic Care Model in people with Pulmonary Disease, Chronic Obstructive and Lung Diseases, Obstructive, run by Hasan Kalyoncu University 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 28 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of self-efficacy status (time frame: 0 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05029557, which also lists 1 linked publication.
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 28 Feb 2024.