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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06217718
Other study ID # MarmaraU-HEM-ZA-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 20, 2024
Est. completion date October 20, 2024

Study information

Verified date June 2024
Source Marmara University
Contact Zahide Aksoy, MSc
Phone +90 541 304 91 41
Email aksoyzahide@outlook.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 112
Est. completion date October 20, 2024
Est. primary completion date July 20, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Telenursing Interventions
Patient follow-up with phone calls and text messages

Locations

Country Name City State
Turkey Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital Istanbul Maltepe

Sponsors (2)

Lead Sponsor Collaborator
Zahide Aksoy The Scientific and Technological Research Council of Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary COPD Empowerment Scale 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 Lung Function Test 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)
Secondary COPD Assesment Test 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)
Secondary Number of hospital admissions due to COPD exacerbation 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)
Secondary Number of hospitalizations due to COPD exacerbation 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)
Secondary Modified Barthel Index 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)
Secondary Modified Medical Research Council 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)
Secondary Inhaler Device Use Skill Scale 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)
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