The Effect of Mobile Health Applications on Symptom Control, Self-efficacy and Chronic Disease Management in COPD

NCT ID: NCT05295901

Last Updated: 2023-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-31

Study Completion Date

2023-02-15

Brief Summary

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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

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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.

Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled quasi-experimental study
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
participants do not know that they are in the experimental or control group

Study Groups

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experimental group

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

Group Type EXPERIMENTAL

mKOAH application

Intervention Type DEVICE

mobile app installed group

control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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mKOAH application

mobile app installed group

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Muş Alparslan University

OTHER

Sponsor Role lead

Responsible Party

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Neşe Özdemir

research assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Neşe ÖZDEMİR, PhD student

Role: PRINCIPAL_INVESTIGATOR

Muş Alparslan University

Locations

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Neşe ÖZDEMİR

Muş, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Neşe ÖZDEMİR, PhD student

Role: CONTACT

05393081641

Nuray ENÇ, Doktora Prof

Role: CONTACT

Facility Contacts

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Neşe Özdemir, PhD student

Role: primary

05393081641

Nuray ENÇ, Doktora Prof

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 32153009 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31718748 (View on PubMed)

Bernard 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.

Reference Type BACKGROUND
PMID: 31267139 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30669076 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34069028 (View on PubMed)

Other Identifiers

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COPD And Mobile Application

Identifier Type: -

Identifier Source: org_study_id

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