Evaluating Chronic Obstructive Pulmonary Disease (COPD) Patients' Treatment Compliance and Quality of Life Via Telemedicine

Treatment Compliance of Patients Diagnosed With Chronic Obstructive Pulmonary Disease And Their Quality of Life After Follow-up: Evaluation Via Telemedicine

The Covid-19 pandemic has disrupted the follow-up and treatment processes for patients, and telemedicine has emerged as an important alternative method. Our aim was to test compare COPD Assessment Test (CAT) scores, inhaler treatment techniques and adherence between telemedicine-mediated healthcare and healthcare provided face-to-face.

Study Overview

• Status: Completed
• Conditions: Copd; Telehealth
• Intervention / Treatment: Procedure: Telemedicine

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Gazi University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients who were diagnosed with COPD according to Global Initiative for Obstructive Lung Disease (GOLD)
• GOLD spirometric grade 3-4
• At least one hospital admission in the past year
• Acceptable score on the Mini-Mental State Examination
• Residing in Ankara
• Patient or caregiver must understand the process and be able to provide clear information
• Medical records and laboratory test results must be accessible to healthcare professionals
• Patient must have access to prescribed medications
• Comorbidities outside of the lungs are included

Exclusion Criteria:

• Patients diagnosed with asthma
• Patients with lung cancer
• Patients with combined pulmonary fibrosis and emphysema
• Patients with active infections such as pneumonia or COVID-19
• Patients being followed for COPD without spirometry
• Patients with low cognitive function as determined by the Mini-Mental State Examination
• Patients who do not consent to participate in the study
• Patients lacking adequate social support
• Patients with COPD grade 1-2
• Patients with no hospital admissions in the past year
• Patients diagnosed with psychotic disorders
• Patients residing outside of Ankara
• Patients enrolled in inpatient or supervised outpatient rehabilitation programs
• Patients unable to use telemedicine devices or without a caregiver to assist
• Patients and caregivers having difficulty providing information
• Patients without internet access or video call capabilities at home

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Telemedicine group; The study participants were evaluated through telemedicine visits at specific intervals after the baseline visit, with the following schedule: 1st visit: At day 10 post-baseline; 2nd visit: At the end of the 1st month; 3rd visit: At the end of the 3rd month These visits were conducted by the principal investigator using telemedicine. Additional telemedicine visits were arranged for patients in the telemedicine group as required.	Procedure: Telemedicine; Video calls were made with the telemedicine group.
No Intervention: Control group; The visits for the control group, due to being conducted face-to-face in the outpatient clinic, were carried out by the routine attending physician at the clinic, who was not aware of the study. As suggested in the discharge recommendations during the baseline visit (0th visit) for the control group, they were advised to return for a follow-up visit on the 10th day and to schedule these follow-up appointments through the hospital's system. No intervention was made to facilitate the scheduling of these appointments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inhaler adherence	At the end of 3 months, inhaler adherence was compared. A 6-item Inhaler Adherence Scale (IAS) was used to evaluate inhaler treatment compliance. If the patient answered "yes" to even one of the items, they were deemed non-compliant. The questions: ''During the last 3 months; have you at times been careless about using your inhaler or nebulizer?,; have you ever forgotten to use your inhaler or nebulizer?; have you ever stopped using your inhaler because you felt better?; have you ever stopped using your inhaler or nebulizer because you felt worse?; have you ever used your inhaler or nebulizer less than the doctor prescribed because you felt better?; have you ever used your inhaler or nebulizer more than the doctor prescribed because you felt you were having an attack?''.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COPD Assesment Test (CAT) score	The aim of the investigator's study is to test whether telemedicine is a safe and effective method for the follow-up of patients with advanced-stage COPD after exacerbations, to see if there is a difference in treatment adherence after 3 months of observation compared to face-to-face healthcare services, and to evaluate if there is a difference in CAT scores. The COPD Assessment Test (CAT) is a questionnaire for people with COPD. It is designed to measure the impact of COPD on a person's life, and how this changes over time. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.	3 months

Collaborators and Investigators

• Sponsor: Ankara Etlik City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): October 15, 2023

Study Registration Dates

• First Submitted: June 17, 2024
• First Submitted That Met QC Criteria: June 21, 2024
• First Posted (Actual): June 27, 2024

Study Record Updates

• Last Update Posted (Actual): June 27, 2024
• Last Update Submitted That Met QC Criteria: June 21, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: telemedicine; copd; inhaler technique; inhaler adherence
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Chronic Disease; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: GAZISOLMAZ01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No