- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06128902
The Effect of Home-Based Monitoring, Exercise Training
November 7, 2023 updated by: Hanife DURGUN, T.C. ORDU ÜNİVERSİTESİ
The Effect of Home-Based Monitoring, Counseling and Exercise Training Applied to Individuals With Chronic Obstructive Pulmonary Disease by Tele-Counselling Method on Repeated Hospitalization and Quality of Life of Individuals
Chronic obstructive pulmonary disease (COPD); From time to time, significant involvement in dusts or gases and abnormal disease outbreaks are observed, which are observed throughout life in the period when the cause has just emerged, interruption of air flow with disruptions in air flow, shortness of breath, increase in the amount of secretion.
Directly or indirectly, very high costs are incurred in COPD care and promotion.
While mild stages are treated without directed hospitalization, hospitalizations become more frequent as the disease progresses, and the duration of hospitalization in each acute attack increases compared to the next attack.
Acute exacerbations of COPD negatively affect the rates of rehospitalization and emergency service admissions, and the living conditions of this condition, whose long-term cause of death and morbidity has not yet been revealed, do not lead to negative aspects.
Exercise programs applied in chronic diseases should include stopping their illnesses, increasing sleep during the disease, stopping inflammatory acuteness, and in addition to treatment, the rest of the patients should be normal.
It has been stated that it is more effective than home-based hospital system applications in pulmonary regulation, and it has been taken positively from applications compatible with the basic field, as everywhere in the world.
In this direction, the effect of home-based monitoring, education and exercise training applied to individuals with COPD via tele-consultancy method on repeated hospitalization and quality of life is revealed.
Study Overview
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ordu, Turkey
- Nejla KOKSAL
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Agreeing to participate in the research,
- Diagnosed with COPD,
- Able to use a smartphone,
- Oriented and cooperative,
- Does not have a psychiatric disorder that impairs verbal communication, such as schizophrenia or dementia,
- Having no communication problems.
Exclusion Criteria:
- Having alcohol or drug addiction,
- Those with physical disabilities,
- Illiterate.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: intervention group
COPD patients
|
home based exercise and telenursing
Other Names:
|
No Intervention: Control group
COPD patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
repeated hospitalizations
Time Frame: They will be questioned about the number of times they were admitted to hospital due to COPD during 12 weeks.
|
after randomization and 12 weeks later
|
They will be questioned about the number of times they were admitted to hospital due to COPD during 12 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life that COPD patients
Time Frame: Their quality of life will be evaluated with the SF-36 quality of life (Short Form) immediately after randomization and 12 weeks later.
|
after randomization and 12 weeks later
|
Their quality of life will be evaluated with the SF-36 quality of life (Short Form) immediately after randomization and 12 weeks later.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2022
Primary Completion (Actual)
May 30, 2023
Study Completion (Actual)
May 30, 2023
Study Registration Dates
First Submitted
November 2, 2023
First Submitted That Met QC Criteria
November 7, 2023
First Posted (Actual)
November 13, 2023
Study Record Updates
Last Update Posted (Actual)
November 13, 2023
Last Update Submitted That Met QC Criteria
November 7, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- Tele-nursing
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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