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

NCT05295901 | Unknown

• 1 other identifier: COPD And Mobile Application
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

copd; chronic disease; mobile healthy applications

Outcome Measures

Primary Outcomes (10)

• 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

  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.

  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.

  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 .

  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.

  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

  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.

  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.

  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 .

  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.

  1 months

Secondary Outcomes (9)

• application of the COPD self-efficacy scale to the experimental group after the intervention

  3 months

• Application of the patient form to evaluate the chronic disease care after the intervention in the experimental group

  3 months

• Application of the COPD assessment scale to the experimental group after the intervention

  3 months

• Application of the dyspnea scale to the experimental group after the intervention

  3 months

• Application of the post-intervention satisfaction form to the experimental group

  3 months

Study Arms (2)

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

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

Interventions

mKOAH application DEVICE

mobile app installed group

experimental group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Muş Alparslan University: lead

Study Sites (1)

Neşe ÖZDEMİR

Muş, 49000, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• 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.

  PMID: 32153009 BACKGROUND

• 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.

  PMID: 31718748 BACKGROUND

• 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.

  PMID: 31267139 BACKGROUND

• 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.

  PMID: 30669076 BACKGROUND

• 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.

  PMID: 34069028 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Chronic Disease

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Neşe ÖZDEMİR, PhD student

  Muş Alparslan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neşe ÖZDEMİR, PhD student

CONTACT

05393081641; nese_ozdemir23@hotmail.com

Nuray ENÇ, Doktora Prof

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: participants do not know that they are in the experimental or control group
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Model Details: randomized controlled quasi-experimental study

Study Record Dates

• First Submitted: January 22, 2022
• First Posted: March 25, 2022
• Study Start: March 31, 2022
• Primary Completion: August 30, 2022
• Study Completion: February 15, 2023
• Last Updated: February 9, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)