Chronic Obstructive Pulmonary DiseaseNCT04260178
Education-Based İntervention Program for Persons With Chronic Obstructive Pulmonary Disease (EBIPCOPD)
A study testing An Education-Based Intervention Program and handbook (EBIP, hospital and home) and PFT, BMI, BDI, SCMP-G in people with Chronic Obstructive Pulmonary Disease, run by Gönül GÖKÇAY at 2 sites in Turkey (Türkiye).
Trial summary
Obstructive Pulmonary Disease(COPD) treatment, leading to the role of nurses to become more and more important. An Education-Based Intervention Program(EBIP) consists of several steps that aim to achieve better health outcomes through guidingCOPD patients to reduce dyspnea symptoms and improve chronic self-care… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- An Education-Based Intervention Program and handbook (EBIP, hospital and home) and PFT, BMI, BDI, SCMP-G
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 4 Mar 2019to 27 Jun 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals to be included in the study are 18 years of age and over
- have been diagnosed with COPD Stage 2 for six months or more,
- not having been in hospital for one month after discharge, - no communication problems,
- lack of mental confusion,
- conscious and complete orientation
- volunteering to participate in the research,
- It is planned to be conducted with patients living in the center of Kars.
Who cannot join
- Being 18 years old and under,
- KOAH stage 1, 2, 4 diagnosed,
- being a communication problem,
- having mental confusion or
- having any psychiatric problem,
- not volunteering to participate in the research,
- Living outside the Kars center
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Kafkas University-Ataturk Health Services Vocational School
Kars, Turkey/Kars, 36500
Sakarya University Health Faculty of Health Sciences
Sakarya, Turke/Sakarya, 2020
About this study
Official title: The Impact Of An Education-Based Intervention Program (EBIP) On Dyspnea And Chronic Self-Care Management Among Copd Patients: A Randomized Controlled Study
Obstructive Pulmonary Disease(COPD) treatment, leading to the role of nurses to become more and more important. An Education-Based Intervention Program(EBIP) consists of several steps that aim to achieve better health outcomes through guidingCOPD patients to reduce dyspnea symptoms and improve chronic self-care management skills. The aim of this study is to evaluate the dyspnea and chronic self-care management outcomes of EBIP compared to routine care.
Research Hypotheses:
H0: EBIP has no effect on dyspnea or chronic self-care management in COPD patients.
H1: EBIP effects dyspnea outcomes of COPD patients. H2: EBIP effects chronic self-care management outcomes of COPD patients.
Read the detailed description
Abstract:
Background:Non-pharmacological interventions are a valuable aspect of Chronic Obstructive Pulmonary Disease(COPD) treatment, leading to the role of nurses to become more and more important. An Education-Based Intervention Program(EBIP) consists of several steps that aim to achieve better health outcomes through guidingCOPD patients to reduce dyspnea symptoms and improve chronic self-care management skills. The aim of this study is to evaluate the dyspnea and chronic self-care management outcomes of EBIP compared to routine care.
Method:A total of 61 Stage II COPD patients that were hospitalized and treated in the month of January 2019 in a university hospital were selected for the study, who had been discharged less than one month ago and resided downtown. 51 conforming patients were divided into experimental(EBIP intervention) and control groups for a single-blind randomized trial. Data were collected using an introductory information form, pulmonary function test(PFT), the Baseline Dyspnea Index(BDI), body mass index(BMI) and the Self Care Management Process in Chronic Illness(SCMP-G) scale. There were no addition interventions to the control group. The intervention group underwent a 3-month EBIP intervention that included education, house visits and follow-ups through phone calls. The data were analyzed using SPSS version 17.0 with descriptive statistics, x2,Mann Whitney U and Wilcoxon signed-rank tests. p<0.05 was statistically significant.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- An Education-Based Intervention Program and handbook (EBIP, hospital and home), PFT, BMI, BDI, SCMP-G
- Keywords
- COPD, dyspnea, self-care management, nurse education.
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An Education-Based Intervention Program and handbook (EBIP, hospital and home)Other
A handbook was developed in line with the literature and input from two specialist physicians. The handbook consisted of 4 sections that concerned improving breathing exercises, drug compliance, nutrition and illness self-care behavior.
PFT, BMI, BDI, SCMP-GOther
pulmonary function test(PFT), the Baseline Dyspnea Index(BDI), body mass index(BMI) and the Self Care Management Process in Chronic Illness(SCMP-G) scale
| Study group | Role | What they receive |
|---|---|---|
| Experimental groups | Experimental | For the experimental group, EBIP was implemented in three stages:(1) hospital training;(2) home visits + training, which includes motivational interventions that facilitate chronic disease self-care and symptom management with nurse-patient cooperation; and (3) telephone follow-ups and assistance. A handbook was developed in line with the relevant literature and input from two specialist physicians (1,17-20). The handbook consisted of 4 sections that concerned improving breathing exercises, drug compliance, nutrition and illness self-care behavior. The trainings sessions were conducted in a hospital seminar room using PowerPoint presentations. Afterward, patients were asked to demonstrate what they learned, and the parts that were not clear were explained again. The training was concluded after deciding for the first home visit appointment. For patients that could not effectively use the handbook, a close relative was included to all steps of the study. Receives: Other: An Education-Based Intervention Program and handbook (EBIP, hospital and home); Other: PFT, BMI, BDI, SCMP-G |
| Control groups | Other | Control groups were evaluated with an introductory survey form, PFT, BDI, BMI and SCMP-G scales before and after the study. There were no additional interventions to the control group. Receives: Other: PFT, BMI, BDI, SCMP-G |
What is being measured
The primary outcome is the main question the study is designed to answer.
pulmonary function test(PFT)
It is the COPD diagnostic criterion that the ratio of these two values is below 70% by measuring the forced vital capacity (FVC) with PFT and the demanding expiration volume (FEV1) in the first second and the ratio of these two values is calculated by FEV1 / FVC (% FEV1 predicted). According to the GOLD 2019 classification; 1. Stage-mild (FEV1≥80% predicted), 2. Stage-moderate (50% ≤FEV1 <80% predicted), 3. Stage-severe (30% ≤FEV1 <50% predicted), 4. Stage-very severe ( FEV1 <30% predicted). In our study, the changes in FVC, FEV1, FEV1 / FVC (% FEV1) values were measured by including 2nd stage COPD patients.
Measured: Change from PFT at 3 months
Baseline Dyspnea Index(BDI)
The BDI score is based on ratings for three categories: functional impairment, size of task, and extent of effort. Dyspnea in each category is rated on a 5-point scale from 0 (severe) to 4 (intact). The scores of each category are added to create a total dyspnea score (between 0 and 12). Higher scores indicate worse dyspnea.
Measured: Change from BDI at 3 months
Self-Care Management Scale in Chronic Diseases(SCMP-G)
Scale with 35 questions; These two types of protection concepts, defined as self-protection (20 items) and social protection (15 items), constituted two sub-dimensions of the scale. Self-protection sub-dimension items 2, 6, 8, 11, 15, 18, 19, 20, 22, 23 and 25-34 and social-protection sub-dimension 1, 3-5, 7, 9, 10, 12-14, 16 Consists of 17, 21, 24 and 35 items. The assessment of the scale was developed from a 5-point Likert form as 5 (Strongly Agree) and 1 (Never Agree). Questions 3, 15, 19, and 28 on the SCMP-G scale are in the form of a negative question and the evaluation needs to be transformed. Self-care management increases as the score on the SCMP-G scale increases.The overall Cronbach alpha values of the scale are 0.75, 0.78 for the self-protection sub-dimension and 0.78 for the social-protection sub-dimension.
Measured: Change from SCMP-G at 3 months
Secondary outcomes (1)
body mass index(BMI)
BMI was measured using weight and height data. Height was measured with a stadiometer (precision 1 cm) and weight was measured using a standard medical weighing scale (precision 1 kg). The interview was concluded for the control group at this point.
Measured: Change from BMI at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start4 Mar 2019
- Primary completion4 Apr 2019
- Study completion27 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gönül GÖKÇAY
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gönül GÖKÇAY, Kafkas University
- Investigators
- Ayşe ÇEVİRME, Principal investigator, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04260178
- Sponsor's protocol ID
- 80576354-050-99/37
- Status last verified
- Oct 2020
- First submitted
- 24 Jan 2020
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thom DH, Willard-Grace R, Tsao S, Hessler D, Huang B, DeVore D, Chirinos C, Wolf J, Donesky D, Garvey C, Su G. Randomized Controlled Trial of Health Coaching for Vulnerable Patients with Chronic Obstructive Pulmonary Disease. Ann Am Thorac Soc. 2018 Oct;15(10):1159-1168. doi: 10.1513/AnnalsATS.201806-365OC.
PubMed 30130430Baker E, Fatoye F. Patient perceived impact of nurse-led self-management interventions for COPD: A systematic review of qualitative research. Int J Nurs Stud. 2019 Mar;91:22-34. doi: 10.1016/j.ijnurstu.2018.12.004. Epub 2018 Dec 31.
PubMed 30669076Efraimsson EO, Hillervik C, Ehrenberg A. Effects of COPD self-care management education at a nurse-led primary health care clinic. Scand J Caring Sci. 2008 Jun;22(2):178-85. doi: 10.1111/j.1471-6712.2007.00510.x.
PubMed 18489687
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact Of An Education-Based Intervention Program (EBIP) On Dyspnea And Chronic Self-Care Management Among Copd Patients: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04260178
- Acronym / sponsor ID
- 80576354-050-99/37
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, dyspnea, self-care management, nurse education.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Gönül GÖKÇAYUniversity, hospital or other
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 4 Apr 2019 (actual)
- Study completion
- 27 Jun 2019 (actual)
- First posted
- 7 Feb 2020 (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.
Obstructive Pulmonary Disease(COPD) treatment, leading to the role of nurses to become more and more important. An Education-Based Intervention Program(EBIP) consists of several steps that aim to achieve better health outcomes through guidingCOPD patients to reduce dyspnea symptoms and improve chronic self-care management skills. The aim of this study is to evaluate the dyspnea and chronic self-care management outcomes of EBIP compared to routine care.
Research Hypotheses:
H0: EBIP has no effect on dyspnea or chronic self-care management in COPD patients.
H1: EBIP effects dyspnea outcomes of COPD patients. H2: EBIP effects chronic self-care management outcomes of COPD patients.
Detailed description
Abstract:
Background:Non-pharmacological interventions are a valuable aspect of Chronic Obstructive Pulmonary Disease(COPD) treatment, leading to the role of nurses to become more and more important. An Education-Based Intervention Program(EBIP) consists of several steps that aim to achieve better health outcomes through guidingCOPD patients to reduce dyspnea symptoms and improve chronic self-care management skills. The aim of this study is to evaluate the dyspnea and chronic self-care management outcomes of EBIP compared to routine care.
Method:A total of 61 Stage II COPD patients that were hospitalized and treated in the month of January 2019 in a university hospital were selected for the study, who had been discharged less than one month ago and resided downtown. 51 conforming patients were divided into experimental(EBIP intervention) and control groups for a single-blind randomized trial. Data were collected using an introductory information form, pulmonary function test(PFT), the Baseline Dyspnea Index(BDI), body mass index(BMI) and the Self Care Management Process in Chronic Illness(SCMP-G) scale. There were no addition interventions to the control group. The intervention group underwent a 3-month EBIP intervention that included education, house visits and follow-ups through phone calls. The data were analyzed using SPSS version 17.0 with descriptive statistics, x2,Mann Whitney U and Wilcoxon signed-rank tests. p<0.05 was statistically significant.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Experimental groups | Experimental | Other: An Education-Based Intervention Program and handbook (EBIP, hospital and home), Other: PFT, BMI, BDI, SCMP-GFor the experimental group, EBIP was implemented in three stages:(1) hospital training;(2) home visits + training, which includes motivational interventions that facilitate chronic disease self-care and symptom management with nurse-patient cooperation; and (3) telephone follow-ups and assistance. A handbook was developed in line with the relevant literature and input from two specialist physicians (1,17-20). The handbook consisted of 4 sections that concerned improving breathing exercises, drug compliance, nutrition and illness self-care behavior. The trainings sessions were conducted in a hospital seminar room using PowerPoint presentations. Afterward, patients were asked to demonstrate what they learned, and the parts that were not clear were explained again. The training was concluded after deciding for the first home visit appointment. For patients that could not effectively use the handbook, a close relative was included to all steps of the study. |
| Control groups | Other | Other: PFT, BMI, BDI, SCMP-GControl groups were evaluated with an introductory survey form, PFT, BDI, BMI and SCMP-G scales before and after the study. There were no additional interventions to the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Individuals to be included in the study are 18 years of age and over
- have been diagnosed with COPD Stage 2 for six months or more,
- not having been in hospital for one month after discharge, - no communication problems,
- lack of mental confusion,
- conscious and complete orientation
Key exclusion criteria (7 listed)
- Being 18 years old and under,
- KOAH stage 1, 2, 4 diagnosed,
- being a communication problem,
- having mental confusion or
- having any psychiatric problem,
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 |
|---|---|---|
| An Education-Based Intervention Program and handbook (EBIP, hospital and home)A handbook was developed in line with the literature and input from two specialist physicians. The handbook consisted of 4 sections that concerned improving breathing exercises, drug compliance, nutrition and illness self-care behavior. | Other | Experimental groups |
| PFT, BMI, BDI, SCMP-Gpulmonary function test(PFT), the Baseline Dyspnea Index(BDI), body mass index(BMI) and the Self Care Management Process in Chronic Illness(SCMP-G) scale | Other | Control groups, Experimental groups |
Primary outcome
pulmonary function test(PFT)
Time frame: Change from PFT at 3 months
It is the COPD diagnostic criterion that the ratio of these two values is below 70% by measuring the forced vital capacity (FVC) with PFT and the demanding expiration volume (FEV1) in the first second and the ratio of these two values is calculated by FEV1 / FVC (% FEV1 predicted). According to the GOLD 2019 classification; 1. Stage-mild (FEV1≥80% predicted), 2. Stage-moderate (50% ≤FEV1 <80% predicted), 3. Stage-severe (30% ≤FEV1 <50% predicted), 4. Stage-very severe ( FEV1 <30% predicted). In our study, the changes in FVC, FEV1, FEV1 / FVC (% FEV1) values were measured by including 2nd stage COPD patients.
Baseline Dyspnea Index(BDI)
Time frame: Change from BDI at 3 months
The BDI score is based on ratings for three categories: functional impairment, size of task, and extent of effort. Dyspnea in each category is rated on a 5-point scale from 0 (severe) to 4 (intact). The scores of each category are added to create a total dyspnea score (between 0 and 12). Higher scores indicate worse dyspnea.
Self-Care Management Scale in Chronic Diseases(SCMP-G)
Time frame: Change from SCMP-G at 3 months
Scale with 35 questions; These two types of protection concepts, defined as self-protection (20 items) and social protection (15 items), constituted two sub-dimensions of the scale. Self-protection sub-dimension items 2, 6, 8, 11, 15, 18, 19, 20, 22, 23 and 25-34 and social-protection sub-dimension 1, 3-5, 7, 9, 10, 12-14, 16 Consists of 17, 21, 24 and 35 items. The assessment of the scale was developed from a 5-point Likert form as 5 (Strongly Agree) and 1 (Never Agree). Questions 3, 15, 19, and 28 on the SCMP-G scale are in the form of a negative question and the evaluation needs to be transformed. Self-care management increases as the score on the SCMP-G scale increases.The overall Cronbach alpha values of the scale are 0.75, 0.78 for the self-protection sub-dimension and 0.78 for the social-protection sub-dimension.
1 secondary outcome
body mass index(BMI)
Time frame: Change from BMI at 3 months
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 6 Oct 2020.
- Background: PubMed 30130430Thom DH, Willard-Grace R, Tsao S, Hessler D, Huang B, DeVore D, Chirinos C, Wolf J, Donesky D, Garvey C, Su G. Randomized Controlled Trial of Health Coaching for Vulnerable Patients with Chronic Obstructive Pulmonary Disease. Ann Am Thorac Soc. 2018 Oct;15(10):1159-1168. doi: 10.1513/AnnalsATS.201806-365OC.
- Results publication: PubMed 30669076Baker E, Fatoye F. Patient perceived impact of nurse-led self-management interventions for COPD: A systematic review of qualitative research. Int J Nurs Stud. 2019 Mar;91:22-34. doi: 10.1016/j.ijnurstu.2018.12.004. Epub 2018 Dec 31.
- Results publication: PubMed 18489687Efraimsson EO, Hillervik C, Ehrenberg A. Effects of COPD self-care management education at a nurse-led primary health care clinic. Scand J Caring Sci. 2008 Jun;22(2):178-85. doi: 10.1111/j.1471-6712.2007.00510.x.
- Global Inıtıatıve For Chronıc Obstructıve Lung Dısease. Pocket Guıde To Copd Dıagnosıs, Management, And Preventıon.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
PRA-216 COPD Safety and Biomarker Study
Chronic Obstructive Pulmonary Disease (COPD)
RecruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 2
A Study to Evaluate Solrikitug in Participants With COPD (ZION)
COPD
RecruitingPhase 2
To Evaluate the Effect of EXPD-101/FXS7553 Compared With Placebo in Patients With COPD Over 52 Weeks of Treatment
Chronic Obstructive Pulmonary Disease (COPD)
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.
Ayşe ÇEVİRME principal investigator
Sakarya University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing An Education-Based Intervention Program and handbook (EBIP, hospital and home) and PFT, BMI, BDI, SCMP-G in people with Chronic Obstructive Pulmonary Disease, run by Gönül GÖKÇAY at 2 sites 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 7 inclusion and 7 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 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
pulmonary function test(PFT) (time frame: Change from PFT at 3 months). The study lists 3 primary outcomes in all. 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 NCT04260178, which also lists 3 linked publications.
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 6 Oct 2020.