Chronic Obstructive Pulmonary DiseaseNCT05036057
Turkish Version of the Individual Knowledge Statement Questionnaire of Chronic Obstructive Pulmonary Disease (COPD)
An observational study of Chronic Obstructive Pulmonary Disease and Knowledge, Attitudes, Practice, run by Izmir Katip Celebi University.
Trial summary
The Individual Knowledge Statement Questionnaire of Chronic Obstructive Pulmonary Disease (COPD) Patient and Resident Proxies questionnaire, which can be used in patients with Chronic Obstructive Pulmonary Disease (COPD) and their relatives, will be adapted into Turkish and its psychometric properties will be… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Knowledge, Attitudes, Practice
- What is being tested?
- Questionnaire
- How many people
- 340 participants
- Where
- No sites listed yet
- Study dates
- 4 Oct 2021to 4 Oct 2022
- How long will I take part?
- 15 Days
- Phase
- Observational
- 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
Study population: Study population will be patient with diagnosed COPD in the Chest Diseases Outpatient Clinic of Dr Suat Seren Chest Diseases and Surgery Training and Research Hospital, and their proxies.
Who may be able to join
- Being 18 years or older
- Being diagnosed with COPD by a specialist physician (for patients)
- Being clinically stable (For patients, no history of hospital admission/hospitalization due to exacerbation in the last 4 weeks)
- Having information about the diagnosis (For patients)
- To read, write and understand Turkish
- Volunteering to participate in the study
- Being a proxy of the patient (living with the patient regardless of whether they are providing care or not)
Who cannot join
- Having musculoskeletal, neurological, cardiac, and/or cognitive problems other than COPD, which may create a caregiver burden for the patient's relative
About this study
Official title: Investigation of the Psychometric Properties of the Turkish Version of the Individual Knowledge Statement Questionnaire of Chronic Obstructive Pulmonary Disease (COPD) Patient and Resident Proxies
The Individual Knowledge Statement Questionnaire of Chronic Obstructive Pulmonary Disease (COPD) Patient and Resident Proxies questionnaire, which can be used in patients with Chronic Obstructive Pulmonary Disease (COPD) and their relatives, will be adapted into Turkish and its psychometric properties will be examined, and the knowledge level of patients and their relatives about the disease and general health will be investigated.
Read the detailed description
The socio-demographic characteristics of the patients and their relatives will be obtained by asking to them by mutual interview method.
A disease-specific test, the COPD Assessment Test (CAT), will be used to assess patients' own health, and the St George Respiratory Questionnaire (SGRQ) will be used to assess patients' quality of life.
Comorbidities reported by the patient and their relatives will be filled in the Charlson Comorbidity Index. The dyspnea that patients encounter in their daily lives will be questioned with the Modified Medical Research Council (mMRC) Dyspnea Scale.
The "Individual Knowledge Statements of Patients and Resident Proxies" will be used for the individual information of the patient and their relatives about the disease and general health.
There is no control group in the study. SGRQ, CAT and numerical rating scale will be used for the validity of the Turkish version of Individual Knowledge Statements of Patients and Resident Proxies. For the test-retest, the evaluation will be done again after 15 days.
- Being tested
- Questionnaire
- Keywords
- COPD, patient knowledge, proxies
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Patients will do the Individual Knowledge Statement Questionnaire of Chronic Obstructive Pulmonary Disease (COPD), the COPD Assesment Test (CAT), the Saint George Respiratory Disease Questionnaire (SGRQ), the Charlson Comorbidity Index, and will rate the disease and general knowledge level on a numerical scale.
Proxies of patients will do the Individual Knowledge Statement Questionnaire of Chronic Obstructive Pulmonary Disease (COPD) and will rate the disease and general knowledge level on a numerical scale.
| Study group | Role | What they receive |
|---|---|---|
| COPD patients and their proxies | Patients will do the Individual Knowledge Statement Questionnaire of Chronic Obstructive Pulmonary Disease (COPD), the COPD Assesment Test (CAT), the Saint George Respiratory Disease Questionnaire (SGRQ), the Charlson Comorbidity Index, and will rate the disease and general knowledge level on a numerical scale.
Proxies of patients will do the Individual Knowledge Statement Questionnaire of Chronic Obstructive Pulmonary Disease (COPD) and will rate the disease and general knowledge level on a numerical scale. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Individual Knowledge Statement Questionnaire of Chronic Obstructive Pulmonary Disease (COPD)
The scale is a 34-item questionnaire that evaluates the knowledge of COPD patients and their relatives about the disease and general health.
All of 34 statements can be answered as "true", "false" or "don't know". A score out of 34 points will be obtained by giving 1 point to each correct answer appropriate to the question.
Higher score will show more knowledge level. It will done by patients and their proxies.
Measured: Baseline
Secondary outcomes (6)
COPD Assesment Test (CAT)
The COPD Assessment Test (CAT) is a questionnaire, which consist of 8 questions, for people with COPD. It is designed to measure the impact of COPD on a person's life, and how this changes over time. The eight questions are each rated on a scale of 0 to 5. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. It will done by patients.
Measured: Baseline
The modified Medical Research Council (mMRC) scale
The mMRC scale is a self-rating tool to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4: 0, no breathlessness except on strenuous exercise; 1, shortness of breath when hurrying on the level or walking up a slight hill; 2, walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level; 3, stops for breath after walking ∼100 m or after few minutes on the level; and 4, too breathless to leave the house, or breathless when dressing or undressing.
It will done by patients.
Measured: Baseline
Charlson Comorbidity Index
The Charlson Comorbidity Index is a method of categorizing comorbidities of patients based on the International Classification of Diseases (ICD) diagnosis codes found in administrative data, such as hospital abstracts data. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome will result in mortality or higher resource use.
Measured: Baseline
The St George's Respiratory Questionnaire (SGRQ)
The St George's Respiratory Questionnaire (SGRQ) is a validated, commonly used questionnaire for measuring quality of life in patients with chronic obstructive pulmonary disease (COPD). It consists of 76 items in three domains (symptoms, activity, impact of disease on daily life).
A total score of SGRQ is calculated from 0 (no health impairment) to 100 (maximum health impairment). There are also the score of each domain are scored from 0 to 100.
Measured: Baseline
Knowledge Score 0-10 Numerical Rating
The 11-point numeric scale ranges from '0' (e.g. "nothing known") to '10' (e.g. "maximal knowledge").
It can be administered verbally. Scores range from 0-10 points, with higher scores indicating greater knowledge. It will done by patients and their proxies. They will be asked to rate their level of knowledge about COPD and general health.
Measured: Baseline
The Sociodemographic Characteristics
The sociodemographic characteristics of the patient and their relatives will be recorded in the registration form.
Socio-demographic information will be asked from people and their relatives by mutual interview method.
Age, gender, marital status, education level, occupation, medical history, duration of COPD, regularly used medications - oxygen support - non-invasive mechanical ventilation (NIMV), smoking status, alcohol consumption, exercise habits, attacks and pulmonary rehabilitation histories will be questioned in this section.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start4 Oct 2021 (estimated)
- Primary completion25 Nov 2021 (estimated)
- Study completion4 Oct 2022 (estimated)
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 340 participants (estimated)
- Target duration
- 15 Days
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Collaborators
- Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
- Responsible party
- Principal investigator, Ilknur Naz, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036057
- Sponsor's protocol ID
- 2021-GOKAE-0221
- Status last verified
- Sep 2021
- First submitted
- 2 Sep 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Psychometric Properties of the Turkish Version of the Individual Knowledge Statement Questionnaire of Chronic Obstructive Pulmonary Disease (COPD) Patient and Resident Proxies
- ClinicalTrials.gov ID
- NCT05036057
- Acronym / sponsor ID
- 2021-GOKAE-0221
- Keywords
- COPD, patient knowledge, proxies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Collaborators
- Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
- Study start
- 4 Oct 2021 (estimated)
- Primary completion
- 25 Nov 2021 (estimated)
- Study completion
- 4 Oct 2022 (estimated)
- First posted
- 5 Sep 2021 (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 Individual Knowledge Statement Questionnaire of Chronic Obstructive Pulmonary Disease (COPD) Patient and Resident Proxies questionnaire, which can be used in patients with Chronic Obstructive Pulmonary Disease (COPD) and their relatives, will be adapted into Turkish and its psychometric properties will be examined, and the knowledge level of patients and their relatives about the disease and general health will be investigated.
Detailed description
The socio-demographic characteristics of the patients and their relatives will be obtained by asking to them by mutual interview method.
A disease-specific test, the COPD Assessment Test (CAT), will be used to assess patients' own health, and the St George Respiratory Questionnaire (SGRQ) will be used to assess patients' quality of life.
Comorbidities reported by the patient and their relatives will be filled in the Charlson Comorbidity Index. The dyspnea that patients encounter in their daily lives will be questioned with the Modified Medical Research Council (mMRC) Dyspnea Scale.
The "Individual Knowledge Statements of Patients and Resident Proxies" will be used for the individual information of the patient and their relatives about the disease and general health.
There is no control group in the study. SGRQ, CAT and numerical rating scale will be used for the validity of the Turkish version of Individual Knowledge Statements of Patients and Resident Proxies. For the test-retest, the evaluation will be done again after 15 days.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD patients and their proxies | – | Other: QuestionnairePatients will do the Individual Knowledge Statement Questionnaire of Chronic Obstructive Pulmonary Disease (COPD), the COPD Assesment Test (CAT), the Saint George Respiratory Disease Questionnaire (SGRQ), the Charlson Comorbidity Index, and will rate the disease and general knowledge level on a numerical scale. Proxies of patients will do the Individual Knowledge Statement Questionnaire of Chronic Obstructive Pulmonary Disease (COPD) and will rate the disease and general knowledge level on a numerical scale. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will be patient with diagnosed COPD in the Chest Diseases Outpatient Clinic of Dr Suat Seren Chest Diseases and Surgery Training and Research Hospital, and their proxies.
Key inclusion criteria (7 listed)
- Being 18 years or older
- Being diagnosed with COPD by a specialist physician (for patients)
- Being clinically stable (For patients, no history of hospital admission/hospitalization due to exacerbation in the last 4 weeks)
- Having information about the diagnosis (For patients)
- To read, write and understand Turkish
Key exclusion criteria (1 listed)
- Having musculoskeletal, neurological, cardiac, and/or cognitive problems other than COPD, which may create a caregiver burden for the patient's relative
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 |
|---|---|---|
| QuestionnairePatients will do the Individual Knowledge Statement Questionnaire of Chronic Obstructive Pulmonary Disease (COPD), the COPD Assesment Test (CAT), the Saint George Respiratory Disease Questionnaire (SGRQ), the Charlson Comorbidity Index, and will rate the disease and general knowledge level on a numerical scale. Proxies of patients will do the Individual Knowledge Statement Questionnaire of Chronic Obstructive Pulmonary Disease (COPD) and will rate the disease and general knowledge level on a numerical scale. | Other | COPD patients and their proxies |
Primary outcome
Individual Knowledge Statement Questionnaire of Chronic Obstructive Pulmonary Disease (COPD)
Time frame: Baseline
The scale is a 34-item questionnaire that evaluates the knowledge of COPD patients and their relatives about the disease and general health. All of 34 statements can be answered as "true", "false" or "don't know". A score out of 34 points will be obtained by giving 1 point to each correct answer appropriate to the question. Higher score will show more knowledge level. It will done by patients and their proxies.
6 secondary outcomes
COPD Assesment Test (CAT)
Time frame: Baseline
The modified Medical Research Council (mMRC) scale
Time frame: Baseline
Charlson Comorbidity Index
Time frame: Baseline
The St George's Respiratory Questionnaire (SGRQ)
Time frame: Baseline
Knowledge Score 0-10 Numerical Rating
Time frame: Baseline
The Sociodemographic Characteristics
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease and Knowledge, Attitudes, Practice, run by Izmir Katip Celebi University.
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 1 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: status not confirmed, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Individual Knowledge Statement Questionnaire of Chronic Obstructive Pulmonary Disease (COPD) (time frame: Baseline). 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 5 Sep 2021.