NCT05036057

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
340

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
29 days until next milestone

Study Start

First participant enrolled

October 4, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2022

Completed
Last Updated

September 5, 2021

Status Verified

September 1, 2021

Enrollment Period

2 months

First QC Date

September 2, 2021

Last Update Submit

September 3, 2021

Conditions

Keywords

COPDpatient knowledgeproxies

Outcome Measures

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.

    Baseline

Secondary Outcomes (6)

  • COPD Assesment Test (CAT)

    Baseline

  • The modified Medical Research Council (mMRC) scale

    Baseline

  • Charlson Comorbidity Index

    Baseline

  • The St George's Respiratory Questionnaire (SGRQ)

    Baseline

  • Knowledge Score 0-10 Numerical Rating

    Baseline

  • +1 more secondary outcomes

Study Arms (1)

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

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.

COPD patients and their proxies

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveBehavior

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
15 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 2, 2021

First Posted

September 5, 2021

Study Start

October 4, 2021

Primary Completion

November 25, 2021

Study Completion

October 4, 2022

Last Updated

September 5, 2021

Record last verified: 2021-09