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

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05036057
• Other study ID #: 2021-GOKAE-0221
• Status: Not yet recruiting
• Start date: October 4, 2021
• Est. completion date: October 4, 2022

Study information

• Verified date: September 2021
• Source: Izmir Katip Celebi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 examined, and the knowledge level of patients and their relatives about the disease and general health will be investigated.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 340
• Est. completion date: October 4, 2022
• Est. primary completion date: November 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Knowledge, Attitudes, Practice
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Questionnaire
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Izmir Katip Celebi University	Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline