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Status unknownNCT05036057Updated Sep 5, 2021

Turkish Version of the Individual Knowledge Statement Questionnaire of Chronic Obstructive Pulmonary Disease (COPD)

An observational study in Chronic Obstructive Pulmonary Disease and Knowledge, Attitudes, Practice, sponsored by Izmir Katip Celebi University. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-05.

Sponsored by Izmir Katip Celebi University · Observational

The sponsor has not verified this record recently (last verified Sep 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
340
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease
  • Knowledge, Attitudes, Practice

Keywords

  • COPD
  • patient knowledge
  • proxies
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's planned enrollment of 340 is above the median of 157 across 929 observational studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Izmir Katip Celebi University is the lead sponsor of 191 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • Having musculoskeletal, neurological, cardiac, and/or cognitive problems other than COPD, which may create a caregiver burden for the patient's relative
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
340 participants (estimated)
Target follow-up
15 Days
Patient registry
Yes

Groups and cohorts

  • 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.

    Other: Questionnaire

Interventions

  • OtherQuestionnaire

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

Secondary outcomes

  1. 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.

    Time frame: Baseline

  2. 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.

    Time frame: Baseline

  3. 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.

    Time frame: Baseline

  4. 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.

    Time frame: Baseline

  5. 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.

    Time frame: Baseline

  6. 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.

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05036057
Lead sponsor
Izmir Katip Celebi University
Collaborators
Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
Responsible party
Ilknur Naz (Associate Professor, Izmir Katip Celebi University) — Principal investigator
First posted
Sep 5, 2021
Start date
Oct 4, 2021 (estimated)
Primary completion
Nov 25, 2021 (estimated)
Completion
Oct 4, 2022 (estimated)
Last update
Sep 5, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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