NCT06286072

Brief Summary

COPD is an important respiratory system disease that progresses with damage to the airways.Increased mucus secretion and thickening in the airways causes obstruction.This obstruction causes symptoms such as shortness of breath, cough, phlegm and wheezing.The most obvious problem that the emerging symptoms will cause for the patient is fatigue.Coping with fatigue is an important problem in COPD. The main questions it aims to answer are:

  • Dyspnea severity,
  • COPD general conditions and
  • Fatigue level. The results obtained will be interpreted by comparing between 3 groups.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

November 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 29, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

8 months

First QC Date

February 22, 2024

Last Update Submit

August 6, 2024

Conditions

Keywords

COPDFatiguedyspneaTrainingMessage

Outcome Measures

Primary Outcomes (2)

  • Fatigue Level

    Evaluated with COPD ASTHMA FATIGUE SCALE.

    Applied at baseline and after 8 weeks.

  • Dyspnea Severity

    Evaluated with mMRC Dyspnea Scale

    Applied at baseline and after 8 weeks.

Secondary Outcomes (1)

  • COPD general condition

    Applied at baseline and after 8 weeks.

Study Arms (3)

Training and Message Group

EXPERIMENTAL

Patients in this group were given training for 3 consecutive days during their stay in the hospital. Day 1: general information about the disease, medication use Day 2: Physiology of fatigue, factors causing fatigue, and the relationship between COPD and fatigue. Day 3 Strategies to cope with fatigue (Breathing exercises, good thinking, etc.) Patients were messaged twice a week after they were discharged. Message sent for 8 weeks. Short, motivating and reminder messages were used. For example; * When I can control my shortness of breath, my fatigue level decreases significantly. * Excessive thinking and stress lead to more fatigue. That's why I stay away from negative thoughts. At the baseline and 8th weeks, the patients were interviewed again and their dyspnea and fatigue levels were measured again.

Other: Education and message

Training Group

EXPERIMENTAL

Patients in this group were given training for 3 consecutive days during their stay in the hospital. Day 1: general information about the disease, medication use Day 2: Physiology of fatigue, factors causing fatigue, and the relationship between COPD and fatigue. Day 3 Strategies to cope with fatigue (Breathing exercises, good thinking, etc.) No other treatment was performed on these patients. At the baseline and end of 8 weeks, the patients were interviewed again and their dyspnea and fatigue levels were measured again.

Other: Education and message

Routine Treatment and Care Group

ACTIVE COMPARATOR

These patients received routine treatment and care in the clinic. No training was given. Message not sent. At the baseline and 8th weeks, the patients were interviewed again and their dyspnea and fatigue levels were measured again.

Other: Education and message

Interventions

COPD general education content and fatigue-specific coping strategies. Messages sent to phones

Routine Treatment and Care GroupTraining GroupTraining and Message Group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with COPD for the last 1 year
  • Hospitalized for at least 3 days,
  • Voluntary patients

You may not qualify if:

  • Under 18 years old
  • Over 85 years old
  • Those with chronic fatigue syndrome
  • Those with severe heart failure
  • Those who had surgery in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yasemin CEYHAN

Kırşehir, Center, 40100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveFatigueDyspnea

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsRespiration DisordersSigns and Symptoms, Respiratory

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Yasemin CEYHAN, PhD

    Kirsehir Ahi Evran Universitesi

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomised Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Proffesor

Study Record Dates

First Submitted

February 22, 2024

First Posted

February 29, 2024

Study Start

November 1, 2023

Primary Completion

June 30, 2024

Study Completion

August 30, 2024

Last Updated

August 7, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations