The Effect of Telenursing Interventions in Empowering Patients With COPD

March 9, 2025 updated by: Zahide Aksoy

The Effect of Empowerment Model-Based Telenursing Interventions in Empowering Patients With COPD

The aim of this study is to evaluate the effect of telenursing interventions based on the empowerment model in empowering patients with COPD.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patient empowerment is gaining importance and popularity day by day as it can be sustained through telehealth applications. The importance of using communication technologies in providing health care services has become more evident during the COVID-19 pandemic. When integrated into healthcare, technology-centric services provide continuous and easily accessible health data for patients and help facilitate self-monitoring. With tele-nursing, COPD patients can be strengthened in health literacy by teaching them how to access accurate and reliable resources. Through tele-nursing, online support groups and forums can be created among COPD patients so that patients can share their experiences with each other. In this way, social support is provided to patients who have to remain in social isolation due to their illness.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
    • Maltepe
      • Istanbul, Maltepe, Turkey, 34844
        • Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Having a confirmed COPD diagnosis for at least one year
  • being literate,
  • Having the cognitive and mental competence to answer questions,
  • Being able to use a mobile phone,
  • Disease symptoms are at a level that does not interfere with communication,
  • Being in COPD Stage 2 and Stage 3 according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD: Global Initiative for Chronic Obstructive Lung Disease) criteria (30% ≤ FEV1 <80% (of expected)),

Exclusion Criteria:

  • The disease is in the acute exacerbation period,
  • Dyspnea is at a level that prevents cooperation,
  • Having sensory loss regarding vision, hearing and speech,
  • Refusal to sign informed consent forms
  • It is the refusal of the research to complete the data collection tools.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Telenursing Interventions Group
Participants in this group will receive five hours of face-to-face empowerment training. After the training, the experimental group will be monitored remotely by the researcher nurse via tele-nursing interventions for 12 weeks. Participants will be given a pulse oximeter, symptom diary, action plan, oxygen saturation-pulse monitoring chart. Participants will be asked to measure their oxygen saturation and pulse once a day for 12 weeks and record it on the chart. Participants will also be asked to record their complaints in their symptom diary. Participants will be called by the researcher every two weeks (on Thursdays) and informative and reminding text messages prepared specifically for the disease will be sent to the participants three times a week for 12 weeks. Participants will be able to reach the researchers by phone whenever they need.
Other: Telenursing Interventions
Patient follow-up with phone calls and text messages
No Intervention: No Intervention Group
Participants in this group will be given a pulse oximeter, symptom diary, action plan, oxygen saturation-pulse monitoring chart. No intervention will be taken.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
COPD Empowerment Scale
Time Frame: Pre-test, Post-test (3rd month), Follow-up Test (6th month)
A 31-item scale that evaluates the impact of interventions on individuals with COPD.
Pre-test, Post-test (3rd month), Follow-up Test (6th month)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Lung Function Test
Time Frame: Pre-test, Post-test (3rd month), Follow-up Test (6th month)
A spirometri test that evaluates lung capacity. FEV1 values will increase after the intervention.
Pre-test, Post-test (3rd month), Follow-up Test (6th month)
COPD Assesment Test
Time Frame: Pre-test, Post-test (3rd month), Follow-up Test (6th month)
It is an eight-item test that measures the effects of COPD and deterioration in health status. CAT assessment test score; 0-10 is low 11-20 is considered medium effective, 21-30 is considered highly effective, and 31-40 is considered very high effective.
Pre-test, Post-test (3rd month), Follow-up Test (6th month)
Number of hospital admissions due to COPD exacerbation
Time Frame: Pre-test, Post-test (3rd month), Follow-up Test (6th month)
The number of hospital admissions due to COPD exacerbation in the experimental group will decrease.
Pre-test, Post-test (3rd month), Follow-up Test (6th month)
Number of hospitalizations due to COPD exacerbation
Time Frame: Pre-test, Post-test (3rd month), Follow-up Test (6th month)
The number of hospitalizations due to COPD exacerbation in the experimental group will decrease.
Pre-test, Post-test (3rd month), Follow-up Test (6th month)
Modified Barthel Index
Time Frame: Pre-test, Post-test (3rd month), Follow-up Test (6th month)
A scale that evaluates physical competence and independence in daily living activities. It evaluates 0-15 points with 10 items. On this scale, where the possible score varies between 0 and 100, the higher the score, the more independent the patient is from other people.
Pre-test, Post-test (3rd month), Follow-up Test (6th month)
Modified Medical Research Council
Time Frame: Pre-test, Post-test (3rd month), Follow-up Test (6th month)
A brief 5-item scale describing dyspnea. Scores between 0 and 1 are considered mild, and scores of 2 and above are considered moderate to severe dyspnea.
Pre-test, Post-test (3rd month), Follow-up Test (6th month)
Inhaler Device Use Skill Scale
Time Frame: Pre-test, Post-test (3rd month), Follow-up Test (6th month)
An observational test that measures inhaler device usage skill, with 10 usage steps explained. 1 point for correct use of each item; Incomplete or incorrect use is given 0 points.
Pre-test, Post-test (3rd month), Follow-up Test (6th month)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zahide Aksoy

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Scientific and Technological Research Council of Turkey

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zahide Aksoy, MSc, Marmara University
  • Study Director: Saime Erol, Ph.D, Marmara University
  • Study Director: Özlem Oruç, M.D, Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 25, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 25, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 25, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 7, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MarmaraU-HEM-ZA-01

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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