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OpenTrials
Completed

NCT Number: NCT06477328

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

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Key information

Conditions

Telehealth COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gazi University

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telemedicine

Procedure

Video calls were made with the telemedicine group.

Primary outcomes

  1. Inhaler adherence

    Time frame: 3 months

    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?''.

Secondary outcomes

  1. COPD Assesment Test (CAT) score

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

Ankara Etlik City Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 27, 2024
Registry last updated
Jun 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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