CopdNCT06217718
The Effect of Telenursing Interventions in Empowering Patients With COPD
A study testing Telenursing Interventions in people with Copd and Empowerment, run by Zahide Aksoy at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Copd, Empowerment, Empowerment, Patient
- What is being tested?
- Telenursing Interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jun 2024to 25 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)),
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital
Istanbul, Maltepe, 34844
About this study
Official title: 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.
Read the 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.
- Conditions
- Copd, Empowerment, Empowerment, Patient, Self Efficacy
- Being tested
- Telenursing Interventions
- Keywords
- telenursing, empowerment, Pulmonary Disease, Chronic Obstructive
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Empowerment, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telenursing InterventionsOther
Patient follow-up with phone calls and text messages
| Study group | Role | What they receive |
|---|---|---|
| Telenursing Interventions Group | Experimental | 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. Receives: Other: Telenursing Interventions |
| No Intervention Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
COPD Empowerment Scale
A 31-item scale that evaluates the impact of interventions on individuals with COPD.
Measured: Pre-test, Post-test (3rd month), Follow-up Test (6th month)
Secondary outcomes (7)
Lung Function Test
A spirometri test that evaluates lung capacity. FEV1 values will increase after the intervention.
Measured: Pre-test, Post-test (3rd month), Follow-up Test (6th month)
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.
Measured: Pre-test, Post-test (3rd month), Follow-up Test (6th month)
Number of hospital admissions due to COPD exacerbation
The number of hospital admissions due to COPD exacerbation in the experimental group will decrease.
Measured: Pre-test, Post-test (3rd month), Follow-up Test (6th month)
Number of hospitalizations due to COPD exacerbation
The number of hospitalizations due to COPD exacerbation in the experimental group will decrease.
Measured: Pre-test, Post-test (3rd month), Follow-up Test (6th month)
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.
Measured: Pre-test, Post-test (3rd month), Follow-up Test (6th month)
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.
Measured: Pre-test, Post-test (3rd month), Follow-up Test (6th month)
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.
Measured: Pre-test, Post-test (3rd month), Follow-up Test (6th month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start25 Jun 2024
- Primary completion25 Aug 2024
- Study completion25 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CopdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups with experimental and control groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zahide Aksoy
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Sponsor-investigator, Zahide Aksoy, Marmara University
- Investigators
- Zahide Aksoy, MSc, Principal investigator, Marmara UniversitySaime Erol, Ph.D, Study director, Marmara UniversityÖzlem Oruç, M.D, Study director, Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06217718
- Sponsor's protocol ID
- MarmaraU-HEM-ZA-01
- Status last verified
- Mar 2025
- First submitted
- 7 Jan 2024
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aksoy Z, Erol S, Oruc O. Effects of empowerment model-based telenursing interventions on empowerment in individuals with COPD. BMC Nurs. 2025 Dec 19;25(1):52. doi: 10.1186/s12912-025-04225-z.
PubMed 41420230
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Empowerment Model-Based Telenursing Interventions in Empowering Patients With COPD
- ClinicalTrials.gov ID
- NCT06217718
- Acronym / sponsor ID
- MarmaraU-HEM-ZA-01
- Conditions
- Copd, Empowerment, Empowerment, Patient, Self Efficacy
- Keywords
- telenursing, empowerment, Pulmonary Disease, Chronic Obstructive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Zahide AksoyUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 25 Aug 2024 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the effect of telenursing interventions based on the empowerment model in empowering patients with COPD.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups with experimental and control groups
| Arm | Type | Receives |
|---|---|---|
| Telenursing Interventions Group | Experimental | Other: Telenursing InterventionsParticipants 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. |
| No Intervention Group | No intervention | –Participants in this group will be given a pulse oximeter, symptom diary, action plan, oxygen saturation-pulse monitoring chart. No intervention will be taken. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telenursing InterventionsPatient follow-up with phone calls and text messages | Other | Telenursing Interventions Group |
Primary outcome
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.
7 secondary outcomes
Lung Function Test
Time frame: 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)
Number of hospital admissions due to COPD exacerbation
Time frame: 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)
Modified Barthel Index
Time frame: 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)
Inhaler Device Use Skill Scale
Time frame: Pre-test, Post-test (3rd month), Follow-up Test (6th month)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Derived from this study: PubMed 41420230Aksoy Z, Erol S, Oruc O. Effects of empowerment model-based telenursing interventions on empowerment in individuals with COPD. BMC Nurs. 2025 Dec 19;25(1):52. doi: 10.1186/s12912-025-04225-z.
- Individual participant dataSharing planned: No
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A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zahide Aksoy, MSc principal investigator
Marmara University
Saime Erol, Ph.D study director
Marmara University
Özlem Oruç, M.D study director
Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telenursing Interventions in people with Copd and Empowerment, run by Zahide Aksoy at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COPD Empowerment Scale (time frame: Pre-test, Post-test (3rd month), Follow-up Test (6th month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06217718, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.