Chronic Obstructive Pulmonary DiseaseNCT06551103
The Effect of Training Given to Patients With COPD in Line With Pender's Health Promotion Model
A study testing Intervention group trained in line with the Health Promotion Model in people with Chronic Obstructive Pulmonary Disease and Self Efficacy, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted as a randomized controlled experimental study. The study was conducted with patients hospitalized in the chest diseases intensive care unit of a state hospital. The study was terminated with the participation of 140 patients, 70 in each group. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Self Efficacy
- What is being tested?
- Intervention group trained in line with the Health Promotion Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 30 Jun 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- being 18 years of age or older,
- having been diagnosed with COPD at least 6 months ago,
- volunteering to participate in the study,
- being able to speak and understand Turkish and communicate effectively,
- not having a mental or physical disability that would prevent answering the questions.
Who cannot join
- having a psychiatric illness,
- having vision and hearing problems,
- having cognitive dysfunction,
- not volunteering to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Training Given to Patients With COPD in Line With Pender's Health Promotion Model on Self-Efficacy Level
This study was conducted as a randomized controlled experimental study. The study was conducted with patients hospitalized in the chest diseases intensive care unit of a state hospital. The study was terminated with the participation of 140 patients, 70 in each group. Data were collected with Descriptive Information Form and COPD Self-Efficacy Scale.
Read the detailed description
This study was conducted as a randomized controlled experimental study. The study was conducted with patients hospitalized in the chest diseases intensive care unit of a state hospital. The study was terminated with the participation of 140 patients, 70 in each group. Data were collected with the Descriptive Information Form and COPD Self-Efficacy Scale. Self-efficacy of all patients was assessed at the beginning of the study. Patients in the intervention group were given training prepared in line with the health promotion model. The control group received standard practices of the clinic. After three months, patients' self-efficacy was re-evaluated.
- Being tested
- Intervention group trained in line with the Health Promotion Model
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention group trained in line with the Health Promotion ModelBehavioural
A literature review was conducted by the researchers within the scope of Health Promotion Model and a educational material was prepared. With this educational material, the patients in the intervention group were trained in four sessions lasting 25 minutes each.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group trained in line with the Health Promotion Model | Experimental | A literature review was conducted by the researchers within the scope of Health Promotion Model and a educational material was prepared. With this educational material, the patients in the intervention group were trained in four sessions lasting 25 minutes each. Receives: Behavioral: Intervention group trained in line with the Health Promotion Model |
| Control group | No intervention | The control group was subjected to the clinic's standard procedures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Efficacy
Self-efficacy was assessed with the COPD Self-Efficacy Scale. The 34-item COPD Self-Efficacy Scale has 5 sub-dimensions. The items in the scale are ranked from very safe (5 points) to not safe at all (1 point) and are Likert-type. In the evaluation of the scale, the higher the score obtained from the scale, the higher the competence level of the individual in managing respiratory difficulty.
Measured: 3 months after the first test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start1 Dec 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevda Korkut, TC Erciyes University
- Investigators
- SEVDA KORKUT, Principal investigator, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06551103
- Sponsor's protocol ID
- 2023/156
- Status last verified
- Aug 2024
- First submitted
- 9 Aug 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Training Given to Patients With COPD in Line With Pender's Health Promotion Model on Self-Efficacy Level
- ClinicalTrials.gov ID
- NCT06551103
- Acronym / sponsor ID
- 2023/156
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 13 Aug 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.
This study was conducted as a randomized controlled experimental study. The study was conducted with patients hospitalized in the chest diseases intensive care unit of a state hospital. The study was terminated with the participation of 140 patients, 70 in each group. Data were collected with Descriptive Information Form and COPD Self-Efficacy Scale.
Detailed description
This study was conducted as a randomized controlled experimental study. The study was conducted with patients hospitalized in the chest diseases intensive care unit of a state hospital. The study was terminated with the participation of 140 patients, 70 in each group. Data were collected with the Descriptive Information Form and COPD Self-Efficacy Scale. Self-efficacy of all patients was assessed at the beginning of the study. Patients in the intervention group were given training prepared in line with the health promotion model. The control group received standard practices of the clinic. After three months, patients' self-efficacy was re-evaluated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group trained in line with the Health Promotion Model | Experimental | Behavioral: Intervention group trained in line with the Health Promotion ModelA literature review was conducted by the researchers within the scope of Health Promotion Model and a educational material was prepared. With this educational material, the patients in the intervention group were trained in four sessions lasting 25 minutes each. |
| Control group | No intervention | –The control group was subjected to the clinic's standard procedures. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- being 18 years of age or older,
- having been diagnosed with COPD at least 6 months ago,
- volunteering to participate in the study,
- being able to speak and understand Turkish and communicate effectively,
- not having a mental or physical disability that would prevent answering the questions.
Key exclusion criteria (4 listed)
- having a psychiatric illness,
- having vision and hearing problems,
- having cognitive dysfunction,
- not volunteering to participate in the study.
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 |
|---|---|---|
| Intervention group trained in line with the Health Promotion ModelA literature review was conducted by the researchers within the scope of Health Promotion Model and a educational material was prepared. With this educational material, the patients in the intervention group were trained in four sessions lasting 25 minutes each. | Behavioural | Intervention group trained in line with the Health Promotion Model |
Primary outcome
Self-Efficacy
Time frame: 3 months after the first test
Self-efficacy was assessed with the COPD Self-Efficacy Scale. The 34-item COPD Self-Efficacy Scale has 5 sub-dimensions. The items in the scale are ranked from very safe (5 points) to not safe at all (1 point) and are Likert-type. In the evaluation of the scale, the higher the score obtained from the scale, the higher the competence level of the individual in managing respiratory difficulty.
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 13 Aug 2024.
- Individual participant dataSharing planned: No
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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.
SEVDA KORKUT principal investigator
TC Erciyes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group trained in line with the Health Promotion Model in people with Chronic Obstructive Pulmonary Disease and Self Efficacy, run by TC Erciyes University 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 5 inclusion and 4 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 13 Aug 2024. 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?
Self-Efficacy (time frame: 3 months after the first test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2024.