- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06217718
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
90
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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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
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
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
Investigators
- 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)
June 25, 2024
Primary Completion (Actual)
August 25, 2024
Study Completion (Actual)
November 25, 2024
Study Registration Dates
First Submitted
January 7, 2024
First Submitted That Met QC Criteria
January 18, 2024
First Posted (Actual)
January 22, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 9, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Other Study ID 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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