Clinical trial NCT05295901: The Effect of Mobile Health Applications on Symptom Control, Self-efficacy and Chronic Disease Management in COPD
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: copd
chronic disease
mobile healthy applications
Lead sponsor: Muş Alparslan University
Sponsor class: OTHER
First posted: 2022-03-25
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled quasi-experimental study
Primary purpose: PREVENTION

Brief 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 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

1. 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
2. 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.
3. 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
4. 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.
5. 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.
6. 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.
7. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Application of the patient diagnosis form before the intervention was made to the experimental group
timeFrame: 1 months
measure: Application of the COPD self-efficacy scale to the experimental group before the intervention
timeFrame: 1 months
measure: Application of the patient form scale to evaluate the chronic disease care before the intervention to the experimental group
timeFrame: 1 months
measure: Application of the pre-intervention COPD assessment scale to the experimental group
timeFrame: 1 months
measure: Application of the dyspnea scale to the experimental group before the intervention
timeFrame: 1 months
measure: Application of the patient diagnosis form to the control group
timeFrame: 1 months
measure: Application of the COPD self-efficacy scale to the control group
timeFrame: 1 months
measure: Application of the chronic disease care assessment scale to the control group
timeFrame: 1 months
measure: Application of the COPD assessment scale to the control group
timeFrame: 1 months
measure: Application of the dyspnea scale to the control group
timeFrame: 1 months
Secondary outcomes:
measure: application of the COPD self-efficacy scale to the experimental group after the intervention
timeFrame: 3 months
measure: Application of the patient form to evaluate the chronic disease care after the intervention in the experimental group
timeFrame: 3 months
measure: Application of the COPD assessment scale to the experimental group after the intervention
timeFrame: 3 months
measure: Application of the dyspnea scale to the experimental group after the intervention
timeFrame: 3 months
measure: Application of the post-intervention satisfaction form to the experimental group
timeFrame: 3 months
measure: Application of the COPD self-efficacy scale to the control group
timeFrame: 3 months
measure: Application of the chronic disease care assessment scale to the control group
timeFrame: 3 months
measure: Application of the COPD assessment scale to the control group
timeFrame: 3 months
measure: Application of the dyspnea scale to the control group
timeFrame: 3 months
Other outcomes:
Locations:
city: Muş
country: Turkey
facility: Neşe ÖZDEMİR
Study officials:
affiliation: Muş Alparslan University
name: Neşe ÖZDEMİR, PhD student
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Halpin 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.
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citation: Baker 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.
citation: Alghamdi 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.