NCT06477328

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 27, 2024

Completed
Last Updated

June 27, 2024

Status Verified

June 1, 2024

Enrollment Period

1 year

First QC Date

June 17, 2024

Last Update Submit

June 21, 2024

Conditions

Keywords

telemedicinecopdinhaler adherenceinhaler technique

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • COPD Assesment Test (CAT) score

    3 months

Study Arms (2)

Telemedicine group

ACTIVE COMPARATOR

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

Control group

NO INTERVENTION

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.

Interventions

TelemedicinePROCEDURE

Video calls were made with the telemedicine group.

Telemedicine group

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

  • Dogan ZS, Kokturk N. Evaluation of patients diagnosed with chronic obstructive pulmonary disease in terms of treatment compliance and quality of life after follow-up with telemedicine: a randomized controlled trial. BMC Pulm Med. 2025 Aug 26;25(1):408. doi: 10.1186/s12890-025-03854-z.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: It is a prospective, randomized controlled, method clinical research study. Patients who were hospitalized with COPD exacerbation in the last year were included in the study and were divided into 2 groups.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 17, 2024

First Posted

June 27, 2024

Study Start

July 1, 2022

Primary Completion

July 1, 2023

Study Completion

October 15, 2023

Last Updated

June 27, 2024

Record last verified: 2024-06

Locations