Pulmonary Disease, Chronic ObstructiveNCT05295901
The Effect of Mobile Health Applications on Symptom Control, Self-efficacy and Chronic Disease Management in COPD
A study testing mKOAH application in people with Pulmonary Disease, Chronic Obstructive, run by Muş Alparslan University at 1 site in Turkey (Türkiye).
Trial summary
Name:The effect of the mobile application developed to provide symptom control in chronic obstructive pulmonary patients on self-efficacy and chronic disease management Aim:Considering the covid-19 pandemic seen all over the world, it is aimed to develop a mobile application with an integrated care model that allows… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- mKOAH application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Mar 2022to 15 Feb 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Literate
- Having and using a smartphone (Android or iPhone)
- who have been diagnosed with COPD
- no communication problem
- Not having mental confusion or any psychiatric problems
- Individuals who agree to participate in Stage 2 (50%≤FEV1<80) and Stage 3 (30%≤FEV1<50) and Stage 4 (FEV1<30) research who meet the GOLD 2021 criteria will be included in the study.
Who cannot join
- with cognitive dysfunction
- Comorbid diseases such as severe pulmonary, cardiological and malignant disease
- in exacerbation
- Visual, hearing, cognitive, or dexterity impairment that precludes mobile use
- Patients in Stage 1 (FEV1≥80%) meeting the GOLD 2021 criteria.
Trial locations and contacts
1 site in 1 country.
Nuray ENÇ, Doktora Prof contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Neşe ÖZDEMİR
Muş, 49000
Neşe Özdemir, PhD student, 05393081641, nese_ozdemir23@hotmail.com
Nuray ENÇ, Doktora Prof
About this study
Official title: The Effect of the Mobile Application Developed to Provide Symptom Control in Chronic Obstructive Pulmonary Patients on Self-Efficacy and Chronic Disease Management
Name:The effect of the mobile application developed to provide symptom control in chronic obstructive pulmonary patients on self-efficacy and chronic disease management
Aim:Considering the covid-19 pandemic seen all over the world, it is aimed to develop a mobile application with an integrated care model that allows individuals with chronic obstructive pulmonary disease to control their symptoms that seriously affect their quality of life.
Read the detailed description
In recent years, mobile technologies have been used in the use of self-management applications. Mobile technologies have the opportunity to provide information exchange between the patient and the healthcare professional, to provide patient-specific personalized training, to provide reminders, warnings reinforcements, to increase motivation and behavior change, Reducing the impact of exacerbations through early recognition of symptoms and prompt treatment of individuals with COPD has been shown to be effective in reducing the risk of hospitalization, improving health-related quality of life, and controlling the burden of COPD.In addition, due to the COVID-19 pandemic experienced all around the world, telehealth and mobile technologies were used in the delivery of health services in many countries.
Importance of Research
Considering the covid-19 pandemic seen all over the world and in our country aim to develop a mobile application, which is an integrated care model that allows individuals with chronic obstructive pulmonary disease to control their symptoms that seriously affect their quality of life.
Method
Data Collection Tools
- Patient Diagnosis Form: The "Patient Diagnosis Form", prepared by the researcher in line with the literature, consists of two parts. Section 1: Age, place of residence, gender, educational status, occupation, economic status, health insurance, living with whom, smoking and alcohol consumption status, cigarette pack years, COPD information source, etc. for the patient. will consist of questions. Section 2: COPD diagnosis, presence of other diseases, number of symptoms and attacks, medication used, etc. questions were included
- COPD Self-Efficacy Scale) (CSES):The scale consists of 34 items that determine the degree of self-confidence of COPD patients to manage or avoid breathing difficulties during certain activities, and five sub-dimensions: negative impact, emotional state, physical effort, weather/environment influence, and behavioral risk factors.
- Chronic Disease Care Assessment Scale-Patient Form:The Likert-type and 20-item scale consists of five sub-dimensions: patient participation, decision making, goal setting, problem solving, and monitoring/coordination
- COPD Assessment Test (CAT):It is a scale consisting of 8 parameters in which the effects of the disease on daily life and health status are determined.
- Modifiye Medical Research Council (mMRC)/ Dyspnea Scale:It was used to compare the severity of dyspnea during activity in people with and without lung disease.
- Satisfaction Form: It is a form scored from 1 to 5 by the researcher in order to determine how satisfied the experimental group is with the content of the application at the end of the study.
- mCOPD mobile app:The conceptual and theoretical framework of the mobile application designed for individuals with COPD has been developed based on the chronic care model.Inside the mKOAH mobile application; There are interfaces under the headings of education, management, evaluation, vital parameters, communication, about us, resources.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- mKOAH application
- Keywords
- copd, chronic disease, mobile healthy applications
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mKOAH applicationDevice
mobile app installed group
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | In the pre-test phase (first interview) - Patient Diagnosis Form, COPD Self-efficacy Scale, Chronic Disease Care Assessment Scale-Patient Form, COPD Assessment Test (CAT), Modified Medical Research Council (mMRC) Dyspnea Scale average 15-20 min. will be implemented.
After the pre-test, the mCOPD mobile application will be installed on the phones of the patients and it will be checked whether the mobile application is working. mobile application content will be explained. In addition, a pulse oximeter device will be given to the patients by the researcher to record their pulse and saturation values and its use will be explained.
In the final test phase (final interview); The COPD Self-Efficacy Scale, the Chronic Disease Care Assessment Scale-Patient Form, the COPD Assessment Test (CAT), the Modified Medical Research Council (mMRC) Dyspnea Scale and the Satisfaction Questionnaire will be applied to determine the degree of satisfaction Receives: Device: mKOAH application |
| control group | No intervention | In the pre-test phase (first interview); Patient Diagnosis Form, COPD self-efficacy scale, Chronic Disease Care Assessment Scale-Patient Form, COPD Assessment Test (CAT), Modified Medical Research Council (MRC) Dyspnea Scale will be applied. No action will be taken after the interview. In the final testing phase (final interview); After applying the COPD Self-Efficacy Scale, the Chronic Disease Care Assessment Scale-Patient Form, the COPD Assessment Test (CAT), the Modified Medical Research Council (MRC) Dyspnea Scale, the mCOPD application will be installed on their phones and training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Application of the patient diagnosis form before the intervention was made to the experimental group
Patient Diagnosis Form: Prepared by the researcher in line with the literature, consists of two parts.
Section 1: Age, place of residence, gender, educational status, occupation, economic status, health insurance, living with whom, smoking and alcohol consumption status, cigarette pack years, COPD information source, etc. for the patient. will consist of questions.
Section 2: COPD diagnosis, presence of other diseases, number of symptoms and attacks, medication used, etc. questions were included
Measured: 1 months
Application of the COPD self-efficacy scale to the experimental group before the intervention
COPD Self-Efficacy Scale (CSES):The scale consists of 34 items that determine the degree of self-confidence of COPD patients to manage or avoid breathing difficulties during certain activities, five sub-dimensions: negative impact, emotional state, physical effort, weather/environment influence behavioral risk factors. High scores on managing or avoiding breathing difficulties interpreted as an increase in the degree of confidence.
Measured: 1 months
Application of the patient form scale to evaluate the chronic disease care before the intervention to the experimental group
Chronic Disease Care Assessment Scale-Patient Form:The Likert-type and 20-item scale consists of five sub-dimensions: patient participation, decision making, goal setting, problem solving, and monitoring/coordination. An increase in the scale score indicates that individuals with chronic diseases are satisfied with the care they receive and that chronic disease management is sufficient.
Measured: 1 months
Application of the pre-intervention COPD assessment scale to the experimental group
COPD Assessment Test (CAT):It is a scale consisting of 8 parameters in which the effects of the disease on daily life and health status are determined.The scores of the questions in the test vary between "0-40". The CAT evaluation test score is 0-10 "low impact", 11-20 "medium impact", 21-30 "high impact", and 31-40 " very high impact" evaluated as .
Measured: 1 months
Application of the dyspnea scale to the experimental group before the intervention
Modifiye Medical Research Council (mMRC)/ Dyspnea Scale:It was used to compare the severity of dyspnea during activity in people with and without lung disease. Scoring is between 0-4. Above 1 point indicates severe respiratory distress.
Measured: 1 months
Application of the patient diagnosis form to the control group
Patient Diagnosis Form: Prepared by the researcher in line with the literature, consists of two parts.
Section 1: Age, place of residence, gender, educational status, occupation, economic status, health insurance, living with whom, smoking and alcohol consumption status, cigarette pack years, COPD information source, etc. for the patient. will consist of questions.
Section 2: COPD diagnosis, presence of other diseases, number of symptoms and attacks, medication used, etc. questions were included
Measured: 1 months
Application of the COPD self-efficacy scale to the control group
COPD Self-Efficacy Scale (CSES):The scale consists of 34 items that determine the degree of self-confidence of COPD patients to manage or avoid breathing difficulties during certain activities, five sub-dimensions: negative impact, emotional state, physical effort, weather/environment influence behavioral risk factors. High scores on managing or avoiding breathing difficulties interpreted as an increase in the degree of confidence.
Measured: 1 months
Application of the chronic disease care assessment scale to the control group
Chronic Disease Care Assessment Scale-Patient Form:The Likert-type and 20-item scale consists of five sub-dimensions: patient participation, decision making, goal setting, problem solving, and monitoring/coordination.An increase in scale scores indicates that individuals with chronic disease are satisfied with the care they receive and that chronic disease management is sufficient.
Measured: 1 months
Application of the COPD assessment scale to the control group
COPD Assessment Test (CAT):It is a scale consisting of 8 parameters in which the effects of the disease on daily life and health status are determined.The scores of the questions in the test vary between "0-40". The CAT evaluation test score is 0-10 "low impact", 11-20 "medium impact", 21-30 "high impact", and 31-40 "very high impact" evaluated as .
Measured: 1 months
Application of the dyspnea scale to the control group
Modifiye Medical Research Council (mMRC)/ Dyspnea Scale:It was used to compare the severity of dyspnea during activity in people with and without lung disease.Scoring is between 0-4. Above 1 point indicates severe respiratory distress.
Measured: 1 months
Secondary outcomes (9)
application of the COPD self-efficacy scale to the experimental group after the intervention
COPD Self-Efficacy Scale (CSES):The scale consists of 34 items that determine the degree of self-confidence of COPD patients to manage or avoid breathing difficulties during certain activities, five sub-dimensions: negative impact, emotional state, physical effort, weather/environment influence behavioral risk factors. High scores on managing or avoiding breathing difficulties interpreted as an increase in the degree of confidence.
Measured: 3 months
Application of the patient form to evaluate the chronic disease care after the intervention in the experimental group
Chronic Disease Care Assessment Scale-Patient Form:The Likert-type and 20-item scale consists of five sub-dimensions: patient participation, decision making, goal setting, problem solving, and monitoring/coordination.An increase in scale scores indicates that individuals with chronic disease are satisfied with the care they receive and that chronic disease management is sufficient.
Measured: 3 months
Application of the COPD assessment scale to the experimental group after the intervention
COPD Assessment Test (CAT):It is a scale consisting of 8 parameters in which the effects of the disease on daily life and health status are determined.The scores of the questions in the test vary between "0-40". The CAT evaluation test score is 0-10 "low impact", 11-20 "medium impact", 21-30 "high impact", and 31-40 "high impact" evaluated as .
Measured: 3 months
Application of the dyspnea scale to the experimental group after the intervention
Modifiye Medical Research Council (mMRC)/ Dyspnea Scale:It was used to compare the severity of dyspnea during activity in people with and without lung disease.Scoring is between 0-4. Above 1 point indicates severe respiratory distress.
Measured: 3 months
Application of the post-intervention satisfaction form to the experimental group
Satisfaction Form: It is a form scored from 1 to 5 by the researcher in order to determine how satisfied the experimental group is with the content of the application at the end of the study.
Measured: 3 months
Application of the COPD self-efficacy scale to the control group
COPD Self-Efficacy Scale (CSES):The scale consists of 34 items that determine the degree of self-confidence of COPD patients to manage or avoid breathing difficulties during certain activities, five sub-dimensions: negative impact, emotional state, physical effort, weather/environment influence behavioral risk factors. High scores on managing or avoiding breathing difficulties interpreted as an increase in the degree of confidence.
Measured: 3 months
Application of the chronic disease care assessment scale to the control group
Chronic Disease Care Assessment Scale-Patient Form:The Likert-type and 20-item scale consists of five sub-dimensions: patient participation, decision making, goal setting, problem solving, and monitoring/coordination.An increase in scale scores indicates that individuals with chronic disease are satisfied with the care they receive and that chronic disease management is sufficient.
Measured: 3 months
Application of the COPD assessment scale to the control group
COPD Assessment Test (CAT):It is a scale consisting of 8 parameters in which the effects of the disease on daily life and health status are determined.The scores of the questions in the test vary between "0-40". The CAT evaluation test score is 0-10 "low impact", 11-20 "medium impact", 21-30 "high impact", and 31-40 "very high impact" evaluated as .
Measured: 3 months
Application of the dyspnea scale to the control group
Modifiye Medical Research Council (mMRC)/ Dyspnea Scale:It was used to compare the severity of dyspnea during activity in people with and without lung disease.Scoring is between 0-4. Above 1 point indicates severe respiratory distress.
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 posted25 Mar 2022
- Study start31 Mar 2022
- Primary completion30 Aug 2022
- Study completion15 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled quasi-experimental study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muş Alparslan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neşe Özdemir, Muş Alparslan University
- Investigators
- Neşe ÖZDEMİR, PhD student, Principal investigator, Muş Alparslan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05295901
- Sponsor's protocol ID
- COPD And Mobile Application
- Status last verified
- Feb 2023
- First submitted
- 22 Jan 2022
- Last updated
- 9 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gupta N, Agrawal S, Chakrabarti S, Ish P. COPD 2020 Guidelines - what is new and why? Adv Respir Med. 2020;88(1):38-40. doi: 10.5603/ARM.2020.0080. No abstract available.
PubMed 32153009Halpin DMG, Celli BR, Criner GJ, Frith P, Lopez Varela MV, Salvi S, Vogelmeier CF, Chen R, Mortimer K, Montes de Oca M, Aisanov Z, Obaseki D, Decker R, Agusti A. The GOLD Summit on chronic obstructive pulmonary disease in low- and middle-income countries. Int J Tuberc Lung Dis. 2019 Nov 1;23(11):1131-1141. doi: 10.5588/ijtld.19.0397.
PubMed 31718748Bernard S, Boucher S, McLean L, Moffet H. Mobile technologies for the conservative self-management of urinary incontinence: a systematic scoping review. Int Urogynecol J. 2020 Jun;31(6):1163-1174. doi: 10.1007/s00192-019-04012-w. Epub 2019 Jul 2.
PubMed 31267139Baker E, Fatoye F. Patient perceived impact of nurse-led self-management interventions for COPD: A systematic review of qualitative research. Int J Nurs Stud. 2019 Mar;91:22-34. doi: 10.1016/j.ijnurstu.2018.12.004. Epub 2018 Dec 31.
PubMed 30669076Alghamdi SM, Rajah AMA, Aldabayan YS, Aldhahir AM, Alqahtani JS, Alzahrani AA. Chronic Obstructive Pulmonary Disease Patients' Acceptance in E-Health Clinical Trials. Int J Environ Res Public Health. 2021 May 14;18(10):5230. doi: 10.3390/ijerph18105230.
PubMed 34069028
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Mobile Application Developed to Provide Symptom Control in Chronic Obstructive Pulmonary Patients on Self-Efficacy and Chronic Disease Management
- ClinicalTrials.gov ID
- NCT05295901
- Acronym / sponsor ID
- COPD And Mobile Application
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- copd, chronic disease, mobile healthy applications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Muş Alparslan UniversityUniversity, hospital or other
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 15 Feb 2023 (estimated)
- First posted
- 25 Mar 2022 (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.
Name:The effect of the mobile application developed to provide symptom control in chronic obstructive pulmonary patients on self-efficacy and chronic disease management
Aim:Considering the covid-19 pandemic seen all over the world, it is aimed to develop a mobile application with an integrated care model that allows individuals with chronic obstructive pulmonary disease to control their symptoms that seriously affect their quality of life.
Detailed description
In recent years, mobile technologies have been used in the use of self-management applications. Mobile technologies have the opportunity to provide information exchange between the patient and the healthcare professional, to provide patient-specific personalized training, to provide reminders, warnings reinforcements, to increase motivation and behavior change, Reducing the impact of exacerbations through early recognition of symptoms and prompt treatment of individuals with COPD has been shown to be effective in reducing the risk of hospitalization, improving health-related quality of life, and controlling the burden of COPD.In addition, due to the COVID-19 pandemic experienced all around the world, telehealth and mobile technologies were used in the delivery of health services in many countries.
Importance of Research
Considering the covid-19 pandemic seen all over the world and in our country aim to develop a mobile application, which is an integrated care model that allows individuals with chronic obstructive pulmonary disease to control their symptoms that seriously affect their quality of life.
Method
Data Collection Tools
- Patient Diagnosis Form: The "Patient Diagnosis Form", prepared by the researcher in line with the literature, consists of two parts. Section 1: Age, place of residence, gender, educational status, occupation, economic status, health insurance, living with whom, smoking and alcohol consumption status, cigarette pack years, COPD information source, etc. for the patient. will consist of questions. Section 2: COPD diagnosis, presence of other diseases, number of symptoms and attacks, medication used, etc. questions were included
- COPD Self-Efficacy Scale) (CSES):The scale consists of 34 items that determine the degree of self-confidence of COPD patients to manage or avoid breathing difficulties during certain activities, and five sub-dimensions: negative impact, emotional state, physical effort, weather/environment influence, and behavioral risk factors.
- Chronic Disease Care Assessment Scale-Patient Form:The Likert-type and 20-item scale consists of five sub-dimensions: patient participation, decision making, goal setting, problem solving, and monitoring/coordination
- COPD Assessment Test (CAT):It is a scale consisting of 8 parameters in which the effects of the disease on daily life and health status are determined.
- Modifiye Medical Research Council (mMRC)/ Dyspnea Scale:It was used to compare the severity of dyspnea during activity in people with and without lung disease.
- Satisfaction Form: It is a form scored from 1 to 5 by the researcher in order to determine how satisfied the experimental group is with the content of the application at the end of the study.
- mCOPD mobile app:The conceptual and theoretical framework of the mobile application designed for individuals with COPD has been developed based on the chronic care model.Inside the mKOAH mobile application; There are interfaces under the headings of education, management, evaluation, vital parameters, communication, about us, resources.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized controlled quasi-experimental study
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Device: mKOAH applicationIn the pre-test phase (first interview) - Patient Diagnosis Form, COPD Self-efficacy Scale, Chronic Disease Care Assessment Scale-Patient Form, COPD Assessment Test (CAT), Modified Medical Research Council (mMRC) Dyspnea Scale average 15-20 min. will be implemented. After the pre-test, the mCOPD mobile application will be installed on the phones of the patients and it will be checked whether the mobile application is working. mobile application content will be explained. In addition, a pulse oximeter device will be given to the patients by the researcher to record their pulse and saturation values and its use will be explained. In the final test phase (final interview); The COPD Self-Efficacy Scale, the Chronic Disease Care Assessment Scale-Patient Form, the COPD Assessment Test (CAT), the Modified Medical Research Council (mMRC) Dyspnea Scale and the Satisfaction Questionnaire will be applied to determine the degree of satisfaction |
| control group | No intervention | –In the pre-test phase (first interview); Patient Diagnosis Form, COPD self-efficacy scale, Chronic Disease Care Assessment Scale-Patient Form, COPD Assessment Test (CAT), Modified Medical Research Council (MRC) Dyspnea Scale will be applied. No action will be taken after the interview. In the final testing phase (final interview); After applying the COPD Self-Efficacy Scale, the Chronic Disease Care Assessment Scale-Patient Form, the COPD Assessment Test (CAT), the Modified Medical Research Council (MRC) Dyspnea Scale, the mCOPD application will be installed on their phones and training |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Literate
- Having and using a smartphone (Android or iPhone)
- who have been diagnosed with COPD
- no communication problem
- Not having mental confusion or any psychiatric problems
Key exclusion criteria (5 listed)
- with cognitive dysfunction
- Comorbid diseases such as severe pulmonary, cardiological and malignant disease
- in exacerbation
- Visual, hearing, cognitive, or dexterity impairment that precludes mobile use
- Patients in Stage 1 (FEV1≥80%) meeting the GOLD 2021 criteria.
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 |
|---|---|---|
| mKOAH applicationmobile app installed group | Device | experimental group |
Primary outcome
Application of the patient diagnosis form before the intervention was made to the experimental group
Time frame: 1 months
Patient Diagnosis Form: Prepared by the researcher in line with the literature, consists of two parts. Section 1: Age, place of residence, gender, educational status, occupation, economic status, health insurance, living with whom, smoking and alcohol consumption status, cigarette pack years, COPD information source, etc. for the patient. will consist of questions. Section 2: COPD diagnosis, presence of other diseases, number of symptoms and attacks, medication used, etc. questions were included
Application of the COPD self-efficacy scale to the experimental group before the intervention
Time frame: 1 months
COPD Self-Efficacy Scale (CSES):The scale consists of 34 items that determine the degree of self-confidence of COPD patients to manage or avoid breathing difficulties during certain activities, five sub-dimensions: negative impact, emotional state, physical effort, weather/environment influence behavioral risk factors. High scores on managing or avoiding breathing difficulties interpreted as an increase in the degree of confidence.
Application of the patient form scale to evaluate the chronic disease care before the intervention to the experimental group
Time frame: 1 months
Chronic Disease Care Assessment Scale-Patient Form:The Likert-type and 20-item scale consists of five sub-dimensions: patient participation, decision making, goal setting, problem solving, and monitoring/coordination. An increase in the scale score indicates that individuals with chronic diseases are satisfied with the care they receive and that chronic disease management is sufficient.
Application of the pre-intervention COPD assessment scale to the experimental group
Time frame: 1 months
COPD Assessment Test (CAT):It is a scale consisting of 8 parameters in which the effects of the disease on daily life and health status are determined.The scores of the questions in the test vary between "0-40". The CAT evaluation test score is 0-10 "low impact", 11-20 "medium impact", 21-30 "high impact", and 31-40 " very high impact" evaluated as .
Application of the dyspnea scale to the experimental group before the intervention
Time frame: 1 months
Modifiye Medical Research Council (mMRC)/ Dyspnea Scale:It was used to compare the severity of dyspnea during activity in people with and without lung disease. Scoring is between 0-4. Above 1 point indicates severe respiratory distress.
Application of the patient diagnosis form to the control group
Time frame: 1 months
Patient Diagnosis Form: Prepared by the researcher in line with the literature, consists of two parts. Section 1: Age, place of residence, gender, educational status, occupation, economic status, health insurance, living with whom, smoking and alcohol consumption status, cigarette pack years, COPD information source, etc. for the patient. will consist of questions. Section 2: COPD diagnosis, presence of other diseases, number of symptoms and attacks, medication used, etc. questions were included
Application of the COPD self-efficacy scale to the control group
Time frame: 1 months
COPD Self-Efficacy Scale (CSES):The scale consists of 34 items that determine the degree of self-confidence of COPD patients to manage or avoid breathing difficulties during certain activities, five sub-dimensions: negative impact, emotional state, physical effort, weather/environment influence behavioral risk factors. High scores on managing or avoiding breathing difficulties interpreted as an increase in the degree of confidence.
Application of the chronic disease care assessment scale to the control group
Time frame: 1 months
Chronic Disease Care Assessment Scale-Patient Form:The Likert-type and 20-item scale consists of five sub-dimensions: patient participation, decision making, goal setting, problem solving, and monitoring/coordination.An increase in scale scores indicates that individuals with chronic disease are satisfied with the care they receive and that chronic disease management is sufficient.
Application of the COPD assessment scale to the control group
Time frame: 1 months
COPD Assessment Test (CAT):It is a scale consisting of 8 parameters in which the effects of the disease on daily life and health status are determined.The scores of the questions in the test vary between "0-40". The CAT evaluation test score is 0-10 "low impact", 11-20 "medium impact", 21-30 "high impact", and 31-40 "very high impact" evaluated as .
Application of the dyspnea scale to the control group
Time frame: 1 months
Modifiye Medical Research Council (mMRC)/ Dyspnea Scale:It was used to compare the severity of dyspnea during activity in people with and without lung disease.Scoring is between 0-4. Above 1 point indicates severe respiratory distress.
9 secondary outcomes
application of the COPD self-efficacy scale to the experimental group after the intervention
Time frame: 3 months
Application of the patient form to evaluate the chronic disease care after the intervention in the experimental group
Time frame: 3 months
Application of the COPD assessment scale to the experimental group after the intervention
Time frame: 3 months
Application of the dyspnea scale to the experimental group after the intervention
Time frame: 3 months
Application of the post-intervention satisfaction form to the experimental group
Time frame: 3 months
Application of the COPD self-efficacy scale to the control group
Time frame: 3 months
Application of the chronic disease care assessment scale to the control group
Time frame: 3 months
Application of the COPD assessment scale to the control group
Time frame: 3 months
Application of the dyspnea scale to the control group
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Background: PubMed 32153009Gupta N, Agrawal S, Chakrabarti S, Ish P. COPD 2020 Guidelines - what is new and why? Adv Respir Med. 2020;88(1):38-40. doi: 10.5603/ARM.2020.0080. No abstract available.
- Background: PubMed 31718748Halpin DMG, Celli BR, Criner GJ, Frith P, Lopez Varela MV, Salvi S, Vogelmeier CF, Chen R, Mortimer K, Montes de Oca M, Aisanov Z, Obaseki D, Decker R, Agusti A. The GOLD Summit on chronic obstructive pulmonary disease in low- and middle-income countries. Int J Tuberc Lung Dis. 2019 Nov 1;23(11):1131-1141. doi: 10.5588/ijtld.19.0397.
- Background: PubMed 31267139Bernard S, Boucher S, McLean L, Moffet H. Mobile technologies for the conservative self-management of urinary incontinence: a systematic scoping review. Int Urogynecol J. 2020 Jun;31(6):1163-1174. doi: 10.1007/s00192-019-04012-w. Epub 2019 Jul 2.
- Background: PubMed 30669076Baker E, Fatoye F. Patient perceived impact of nurse-led self-management interventions for COPD: A systematic review of qualitative research. Int J Nurs Stud. 2019 Mar;91:22-34. doi: 10.1016/j.ijnurstu.2018.12.004. Epub 2018 Dec 31.
- Background: PubMed 34069028Alghamdi SM, Rajah AMA, Aldabayan YS, Aldhahir AM, Alqahtani JS, Alzahrani AA. Chronic Obstructive Pulmonary Disease Patients' Acceptance in E-Health Clinical Trials. Int J Environ Res Public Health. 2021 May 14;18(10):5230. doi: 10.3390/ijerph18105230.
- Individual participant dataSharing planned: No
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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
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
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.
Nuray ENÇ, Doktora Prof contact
Neşe ÖZDEMİR, PhD student principal investigator
Muş Alparslan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mKOAH application in people with Pulmonary Disease, Chronic Obstructive, run by Muş Alparslan 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 6 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: status not confirmed, as of the sponsor's last update on 9 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Neşe ÖZDEMİR, PhD student (05393081641, nese_ozdemir23@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Application of the patient diagnosis form before the intervention was made to the experimental group (time frame: 1 months). The study lists 10 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 NCT05295901, which also lists 5 linked publications.
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 9 Feb 2023.