NCT05730088

Brief Summary

Chronic obstructive pulmonary disease (COPD) is a progressive lung disease characterized by persistent airflow obstruction and chronic respiratory symptoms or alpha-1-antitrypsin deficiency in response to inhaled cigarette smoke or other irritants. The excessive morbidity and mortality associated with COPD acute exacerbations represent a significant public health problem that places a high burden on patients, their families and society. In frequent and severe exacerbations, patients may experience a decrease in quality of life, depression, and even death up to one year after hospitalization. Costs associated with COPD are more than $15.5 billion, and hospitalizations and repeated hospital admissions related to acute exacerbations alone account for 70% of all costs. For these reasons, efforts to reduce hospital admissions and hospitalizations associated with recurrent exacerbations are imperative to improve patient's quality of life and reduce the societal burden.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration 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

First Submitted

Initial submission to the registry

January 25, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

February 15, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2023

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

November 22, 2024

Status Verified

November 1, 2024

Enrollment Period

6 months

First QC Date

January 25, 2023

Last Update Submit

November 19, 2024

Conditions

Keywords

COPDhome visitmultiple nursing interventionlife quality

Outcome Measures

Primary Outcomes (3)

  • number of hospital admissions

    Number of hospital admissions

    At the end of the 1st month.

  • number of hospital admissions

    Number of hospital admissions

    At the end of the 3st month.

  • number of hospital admissions

    Number of hospital admissions

    At the end of the 6st month.

Secondary Outcomes (6)

  • Scores from the mMRC Dyspnea scale (on the first encounter)

    At the end of the 1st month.

  • Scores from the mMRC Dyspnea scale (on the first encounter)

    At the end of the 3st month.

  • Scores from the mMRC Dyspnea scale (on the first encounter)

    At the end of the 6st month.

  • Scores from the St George Respiratory Questionnaire

    At the end of the 1st month.

  • Scores from the St George Respiratory Questionnaire

    At the end of the 3st month.

  • +1 more secondary outcomes

Study Arms (2)

intervention group

EXPERIMENTAL

Within the scope of the pre-test, the researcher to the patients who will explain the purpose of the research and agree to participate in the research; Inclusion Criteria Form; Socio-Demographic Information Form; Patient Descriptive Information Form, Modified British Medical Research Council (MRC) Questionnaire, St George Respiratory Questionnaire (Quality of Life Scale) will be used to evaluate patients' symptoms. In addition, the patients in the intervention group will be educated with the training booklet "Educational Guide for COPD Patients" prepared by the researcher by scanning the literature.

Other: health educationOther: Mobile application (Creating a WhatsApp group):Other: Telephone interview:

Not intervention group

NO INTERVENTION

The control group will be subjected to the standard COPD training given in the hospital and no intervention will be made by the researcher. After the trials of the experimental group are completed, the control group will be given a home visit, a COPD training booklet, and audio-visual materials.

Interventions

Health Education: While they are still in the hospital, a 30-minute individually planned education about their disease will be given to patients using the COPD patient education booklet. step 1. Smoking cessation, step 2. Vaccination, step 3. Correct drug use, step 4. Regular exercise, step 5. Healthy eating, step 6. Coping with stress, step 7 Coping with attacks, step 8. Includes regular oxygen therapy. Let's learn nhaverug treatments in coping with COPD, under the title of pulmonary rehabilitation (Respiratory Rehabilitation), methods of coping with shortness of breath, indoor air pollution and outdoor air pollution subheadings.

intervention group

A group will be created through the WhatsApp application for participants in health education and visual and audio materials will be shared through this group every week. In the coming weeks, the researcher will provide consultancy services to those who have problems with the application.

intervention group

Participants will be called every month by the researcher and asked if there are any hospital visits in that month, especially if they are chest disease visits.

intervention group

Eligibility Criteria

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

You may qualify if:

  • Being diagnosed with stage 4 (group D) COPD according to GOLD criteria
  • Being 18 years or older,
  • Having a video computer, tablet or phone,
  • Having an internet connection at home or on the phone,
  • Residing in the city centre of Konya,
  • Not having a communication problem, such as an inability to understand/speak Turkish, that would prevent participation in the research,
  • Being literate,
  • Using an oxygen concentrator at home.

You may not qualify if:

  • Being illiterate,
  • Being diagnosed with first, second and third-stage COPD according to GOLD criteria,
  • Having another lung disease in addition to COPD (Lung cancer-Asthma, etc.),
  • Having physical and/or mental disabilities,
  • Being visually impaired and/or hearing impaired,
  • Having a communication problem that prevents participation in the research, such as an inability to understand/speak Turkish,
  • Having been diagnosed with Covid-19 or having had it in the past,
  • Having a psychiatric disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selçuk Tıp Fakültesi Hastanesi

Konya, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • DİLEK CİNGİL

    https://erbakan.edu.tr/hemsirelikfak

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The Effect of Post-Discharge Multiple Nursing Interventions on the Number of Hospital Admissions, Dyspnea Level, and Quality of Life in COPD Patients Receiving Home Oxygen Therapy: A Randomized Controlled Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

January 25, 2023

First Posted

February 15, 2023

Study Start

February 15, 2023

Primary Completion

August 15, 2023

Study Completion

December 31, 2024

Last Updated

November 22, 2024

Record last verified: 2024-11

Locations