NCT06128902

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 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

May 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

1.1 years

First QC Date

November 2, 2023

Last Update Submit

November 7, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • repeated hospitalizations

    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 Outcomes (1)

  • Quality of life that COPD patients

    Their quality of life will be evaluated with the SF-36 quality of life (Short Form) immediately after randomization and 12 weeks later.

Study Arms (2)

intervention group

EXPERIMENTAL

COPD patients

Other: tele health

Control group

NO INTERVENTION

COPD patients

Interventions

home based exercise and telenursing

Also known as: education
intervention group

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • Having alcohol or drug addiction,
  • Those with physical disabilities,
  • Illiterate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nejla KOKSAL

Ordu, Turkey (Türkiye)

Location

MeSH Terms

Interventions

TelemedicineEducational Status

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services AdministrationSocioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized-control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

November 2, 2023

First Posted

November 13, 2023

Study Start

May 1, 2022

Primary Completion

May 30, 2023

Study Completion

May 30, 2023

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations